| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
% |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1; DOSE=It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d.; EFFECT=SCCP/1044/06 OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE) 16 showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450- 2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% DEGEE in the diet for 13 weeks.; CITATION=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; CITATION_NUMBERS=[28,15]; REFERENCE=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0","dose":"It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d.","duration":"90 days","effect":"SCCP/1044/06 OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE) 16 showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450- 2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% DEGEE in the diet for 13 weeks.","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"%","noael_value":"1","page":16,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: /; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"","effect":"s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: /","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":16,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: /; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"","effect":"oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: /","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":16,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
850 |
mg/kg bw/d |
mouse |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=850-1000; DOSE=10 of the 20 males at the high dose died between week 5 and 12.; EFFECT=l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/d. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 167, 500, and 1500 mg/kg bw/day DEGEE, top dose decreased to 1000 mg/kg bw/d after 3 weeks Route: Oral in diet Exposures: 90 days GLP: / White pigs, groups of 3 males and 3 females, received 0, 167, 500, and 1500 mg/kg bw/day DEGEE (top dose decreased to 1000 mg/kg bw/d after 3 weeks) in the diet for 13 weeks. 1 male; CITATION=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0; CITATION_NUMBERS=[29,3]; REFERENCE=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0","dose":"10 of the 20 males at the high dose died between week 5 and 12.","duration":"90 days","effect":"l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/d. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 167, 500, and 1500 mg/kg bw/day DEGEE, top dose decreased to 1000 mg/kg bw/d after 3 weeks Route: Oral in diet Exposures: 90 days GLP: / White pigs, groups of 3 males and 3 females, received 0, 167, 500, and 1500 mg/kg bw/day DEGEE (top dose decreased to 1000 mg/kg bw/d after 3 weeks) in the diet for 13 weeks. 1 male","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"850-1000","page":17,"route":"oral","species":"mouse","study_id":"sccp_o_082_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
167 |
mg/kg bw/d |
rabbit |
dermal |
13-week |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=167; DOSE=There was a slight anaemia in male pigs at the highest dose.; EFFECT=weights were not reduced during the treatment and increased from about 10 kg to 35 kg during the 13-week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. It is concluded that NOAEL was 167 mg/kg bw/d. Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross pathology at dose level up to 300 mg/kg bw/d. A treatment related histopatological effect was seen in the kidneys of animals at 1000 and 3000 mg/kg bw/d. Ref.: 31 Inhalation; CITATION=Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross; CITATION_NUMBERS=[29,90]; REFERENCE=Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross","dose":"There was a slight anaemia in male pigs at the highest dose.","duration":"13-week","effect":"weights were not reduced during the treatment and increased from about 10 kg to 35 kg during the 13-week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. It is concluded that NOAEL was 167 mg/kg bw/d. Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross pathology at dose level up to 300 mg/kg bw/d. A treatment related histopatological effect was seen in the kidneys of animals at 1000 and 3000 mg/kg bw/d. Ref.: 31 Inhalation","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"167","page":17,"route":"dermal","species":"rabbit","study_id":"sccp_o_082_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1500; DOSE=AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"","effect":"AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1500","page":18,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"","effect":"in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d w","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1500; DOSE=No significant effects were observed at the only dose tested.; EFFECT=kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is u; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant effects were observed at the only dose tested.","duration":"","effect":"kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is u","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1500","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=500; DOSE=ies used this study for their NOAEL of 180 mg/kg bw/d.; EFFECT=ies used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ies used this study for their NOAEL of 180 mg/kg bw/d.","duration":"","effect":"ies used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine.","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
% |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1; DOSE=It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d.; EFFECT=SCCP/1200/08 Opinion on diethyleneglycol monoethylether 21 glutamic-oxaloacetic transaminase which occurred in both sexes at the 5% level indicated impaired renal function. This effect was more pronounced in males which also showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450- 2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% DEGEE in the diet for 13 weeks.; CITATION=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; CITATION_NUMBERS=[28,15]; REFERENCE=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0","dose":"It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d.","duration":"90 days","effect":"SCCP/1200/08 Opinion on diethyleneglycol monoethylether 21 glutamic-oxaloacetic transaminase which occurred in both sexes at the 5% level indicated impaired renal function. This effect was more pronounced in males which also showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/d. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450- 2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% DEGEE in the diet for 13 weeks.","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"%","noael_value":"1","page":21,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"","effect":"s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":21,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"","effect":"oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":21,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
850 |
mg/kg bw/d |
mouse |
oral |
90 days |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=850-1000; DOSE=10 of the 20 males at the high dose died between week 5 and 12.; EFFECT=l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/d. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 167, 500, and 1500 mg/kg bw/day DEGEE, top dose decreased to 1000 mg/kg bw/d after 3 weeks Route: Oral in diet Exposures: 90 days GLP: / White pigs, groups of 3 males and 3 females, received 0, 167, 500, and 1500 mg/kg bw/day DEGEE (top dose decreased to 1000 mg/kg bw/d after 3 weeks) in the diet for 13 weeks. 1 male; CITATION=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0; CITATION_NUMBERS=[29,3]; REFERENCE=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0","dose":"10 of the 20 males at the high dose died between week 5 and 12.","duration":"90 days","effect":"l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/d. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 167, 500, and 1500 mg/kg bw/day DEGEE, top dose decreased to 1000 mg/kg bw/d after 3 weeks Route: Oral in diet Exposures: 90 days GLP: / White pigs, groups of 3 males and 3 females, received 0, 167, 500, and 1500 mg/kg bw/day DEGEE (top dose decreased to 1000 mg/kg bw/d after 3 weeks) in the diet for 13 weeks. 1 male","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"850-1000","page":22,"route":"oral","species":"mouse","study_id":"sccp_o_161_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
167 |
mg/kg bw/d |
rabbit |
dermal |
13-week |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=167; DOSE=There was a slight anaemia in male pigs at the highest dose.; EFFECT=weights were not reduced during the treatment and increased from about 10 kg to 35 kg during the 13-week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. It is concluded that NOAEL was 167 mg/kg bw/d. Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross pathology at dose level up to 300 mg/kg bw/d. A treatment related histopatological effect was seen in the kidneys of animals at 1000 and 3000 mg/kg bw/d. Ref.: 31; CITATION=Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross; CITATION_NUMBERS=[29,90]; REFERENCE=Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross","dose":"There was a slight anaemia in male pigs at the highest dose.","duration":"13-week","effect":"weights were not reduced during the treatment and increased from about 10 kg to 35 kg during the 13-week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. It is concluded that NOAEL was 167 mg/kg bw/d. Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE for 90 days showed no effects on growth, mortality, haematology, clinical chemistry or gross pathology at dose level up to 300 mg/kg bw/d. A treatment related histopatological effect was seen in the kidneys of animals at 1000 and 3000 mg/kg bw/d. Ref.: 31","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"167","page":22,"route":"dermal","species":"rabbit","study_id":"sccp_o_161_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1500; DOSE=AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"","effect":"AEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1500","page":23,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1500; DOSE=ts a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=ts a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ts a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"","effect":"ts a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1500","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=500; DOSE=No significant effects were observed at the only dose tested.; EFFECT=gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant effects were observed at the only dose tested.","duration":"","effect":"gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68%","endpoint":"","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg bw |
- |
oral |
13 weeks |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1500; DOSE=Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.; EFFECT=n in the kidney. Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was signif; CITATION=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; CITATION_NUMBERS=[34,1000,11]; REFERENCE=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11","dose":"Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.","duration":"13 weeks","effect":"n in the kidney. Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was signif","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1500","page":24,"route":"oral","species":"","study_id":"sccs_o_039_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw |
- |
oral |
13 weeks |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.; EFFECT=rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly; CITATION=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; CITATION_NUMBERS=[34,1000,11]; REFERENCE=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11","dose":"rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.","duration":"13 weeks","effect":"rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":24,"route":"oral","species":"","study_id":"sccs_o_039_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1340 |
mg/kg bw |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1340; DOSE=t the intermediate dose, one animal died before study termination.; EFFECT=t the intermediate dose, one animal died before study termination. Lethargy was noted during the first week of treatment. There were no significant effects of treatment with the intermediate dose on haematology or clinical chemistries. The relative liver, heart, and kidney weights (but not absolute weights of these organs) were increased with respect to control. Pathological changes included hyperkeratosis of the stomach (2/10), and spleenic congestion (1/9). No effects were noted at the lowest dose; therefore the NOAEL was established as 1340 mg/kg bw. N Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0.4% ethylene glycol Dose levels: 0, 0.25, 1.0, and 5% DEGEE in the diet Route: Oral in diet Exposures: 90 days GLP: / Wistar rats, groups of 12 males and 12 females, received diet containing 0, 0.25, 1.0, and 5.0% DEGEE for 13 weeks. The growth of male and female rats which was significantly retarded at the 5% level was associat; CITATION=Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0; CITATION_NUMBERS=[6,48,12]; REFERENCE=Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0","dose":"t the intermediate dose, one animal died before study termination.","duration":"90 days","effect":"t the intermediate dose, one animal died before study termination. Lethargy was noted during the first week of treatment. There were no significant effects of treatment with the intermediate dose on haematology or clinical chemistries. The relative liver, heart, and kidney weights (but not absolute weights of these organs) were increased with respect to control. Pathological changes included hyperkeratosis of the stomach (2/10), and spleenic congestion (1/9). No effects were noted at the lowest dose; therefore the NOAEL was established as 1340 mg/kg bw. N Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0.4% ethylene glycol Dose levels: 0, 0.25, 1.0, and 5% DEGEE in the diet Route: Oral in diet Exposures: 90 days GLP: / Wistar rats, groups of 12 males and 12 females, received diet containing 0, 0.25, 1.0, and 5.0% DEGEE for 13 weeks. The growth of male and female rats which was significantly retarded at the 5% level was associat","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1340","page":25,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
% |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1; DOSE=It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day.; EFFECT=ch was significantly retarded at the 5% level was associated with fall in food consumption. No haematological changes were seen at any dietary level. The raised levels of urinary glutamic-oxaloacetic transaminase which occurred in both sexes at the 5% level indicated impaired renal function. This effect was more pronounced in males which also showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450-2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% (about 250 and 2500 mg/kg bw/da; CITATION=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; CITATION_NUMBERS=[28,15]; REFERENCE=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0","dose":"It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day.","duration":"90 days","effect":"ch was significantly retarded at the 5% level was associated with fall in food consumption. No haematological changes were seen at any dietary level. The raised levels of urinary glutamic-oxaloacetic transaminase which occurred in both sexes at the 5% level indicated impaired renal function. This effect was more pronounced in males which also showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450-2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% (about 250 and 2500 mg/kg bw/da","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"%","noael_value":"1","page":25,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet; Intake, males 0, 370- 270, 1020-800, 3240-2540, and 9930-6980 mg/kg bw/day, females 0, 380-320, 1100-820, 4600-3660, and 1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"","effect":"s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet; Intake, males 0, 370- 270, 1020-800, 3240-2540, and 9930-6980 mg/kg bw/day, females 0, 380-320, 1100-820, 4600-3660, and 1","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":26,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet; Intake, males 0, 370- 270, 1020-800, 3240-2540, and 9930-6980 mg/kg bw/day, females 0, 380-320, 1100-820, 4600-3660, and 12880-9080 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"90 days","effect":"oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts” Mice Guideline: / Species/strain: CD-1 mice Group size: 20 males and 20 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet; Intake, males 0, 370- 270, 1020-800, 3240-2540, and 9930-6980 mg/kg bw/day, females 0, 380-320, 1100-820, 4600-3660, and 12880-9080 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0,","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":26,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
850 |
mg/kg bw/day |
mouse |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=850-1000; DOSE=10 of the 20 males at the high dose died between week 5 and 12.; EFFECT=l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/day. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: /; CITATION=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: /; CITATION_NUMBERS=[29,3]; REFERENCE=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: /; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: /","dose":"10 of the 20 males at the high dose died between week 5 and 12.","duration":"90 days","effect":"l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/day. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: /","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"850-1000","page":26,"route":"oral","species":"mouse","study_id":"sccs_o_039_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
167 |
mg/kg bw/day |
rabbit |
dermal |
13- week |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=167; DOSE=There was a slight anaemia in male pigs at the highest dose.; EFFECT=the treatment and increased from about 10 kg to 35 kg during the 13- week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/day (in one of two female pigs). It is concluded that NOAEL was 167 mg/kg bw/day. Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE at dose levels of 0.1, 0.3, 1.0 and 3.0 ml/kg bw 5 times per weeks over a period of 90 days. The animals revealed no effects on growth, mortality, haematology, clinical chemistry or gross pathology at dose level up to 0.3 ml/kg bw (corresponding to about 300 mg/kg bw) A treatment related histopathological effect was seen in the kidneys of the animals at 1000 and 3000 mg/kg bw. N Ref: 6, 48, 51 Ref.; CITATION=Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE at dose levels of 0; CITATION_NUMBERS=[29]; REFERENCE=Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE at dose levels of 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE at dose levels of 0","dose":"There was a slight anaemia in male pigs at the highest dose.","duration":"13- week","effect":"the treatment and increased from about 10 kg to 35 kg during the 13- week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/day (in one of two female pigs). It is concluded that NOAEL was 167 mg/kg bw/day. Ref.: 29 Dermal Rabbits Rabbits receiving dermal treatments (not further specified) of DEGEE at dose levels of 0.1, 0.3, 1.0 and 3.0 ml/kg bw 5 times per weeks over a period of 90 days. The animals revealed no effects on growth, mortality, haematology, clinical chemistry or gross pathology at dose level up to 0.3 ml/kg bw (corresponding to about 300 mg/kg bw) A treatment related histopathological effect was seen in the kidneys of the animals at 1000 and 3000 mg/kg bw. N Ref: 6, 48, 51 Ref.","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"167","page":27,"route":"dermal","species":"rabbit","study_id":"sccs_o_039_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:; EFFECT=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 29 Table 3.11: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:","duration":"90 day","effect":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 29 Table 3.11: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=1340 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 1340; DOSE=Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:; EFFECT=_____________________________ 29 Table 3.11: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSA; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:","duration":"90 day","effect":"_____________________________ 29 Table 3.11: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSA","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1340","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
800 |
mg/kg bw/day |
rat |
oral |
6-week |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=800; DOSE=Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:; EFFECT=died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:","duration":"6-week","effect":"died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"800","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
250 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=250; DOSE=No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat:; EFFECT=t died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat:","duration":"90 day","effect":"t died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=180 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 180; DOSE=Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:; EFFECT=rded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:","duration":"90 day","effect":"rded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 180","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=167 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 167; DOSE=Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg:; EFFECT=males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg:","duration":"90 day","effect":"males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% e","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 167","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=500; DOSE=A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight.; EFFECT=ogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight.","duration":"90 day","effect":"ogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS.","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
200 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=200; DOSE=The observed NOAELs varied from 180 to 1340 mg/kg bw/day.; EFFECT=ey weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"The observed NOAELs varied from 180 to 1340 mg/kg bw/day.","duration":"90 day","effect":"ey weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS.","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
10 |
% |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=10; DOSE=Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOA...; EFFECT=lculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGEE in all cosmetic products (SED 1.97mg/kg bw) would result in a MoS of 203 when compared to the NOAEL of 400 derived from a newly provided study. The use of 10% DEGEE in rinse-off products does not significantly lower this MoS and is not of concern. However, a MOS of 48 is not considered to give sufficient protection in relation to the combined use of DEGEE in the intended concentrations of 5.5% in leave-on and 10% in rinse-off cosmetic products.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOA...","duration":"","effect":"lculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGEE in all cosmetic products (SED 1.97mg/kg bw) would result in a MoS of 203 when compared to the NOAEL of 400 derived from a newly provided study. The use of 10% DEGEE in rinse-off products does not significantly lower this MoS and is not of concern. However, a MOS of 48 is not considered to give sufficient protection in relation to the combined use of DEGEE in the intended concentrations of 5.5% in leave-on and 10% in rinse-off cosmetic products.","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"%","noael_value":"10","page":43,"route":"","species":"human","study_id":"sccs_o_039_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
200 |
mg/kg bw/day |
dog |
oral |
13 week |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=200; DOSE=the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found.; EFFECT=the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found.","duration":"13 week","effect":"the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":45,"route":"oral","species":"dog","study_id":"sccs_o_039_noael_044"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5.4 |
% |
mouse |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=5.4; DOSE=Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 29: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"%","noael_value":"5.4","page":29,"route":"oral","species":"mouse","study_id":"sccs_o_039_noael_052"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5360 |
mg/kg |
rat |
- |
6-week |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=5360; DOSE=Sprague Dawley | M | 5360 mg/kg:; EFFECT=Unlabeled table on page 29: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Sprague Dawley | M | 5360 mg/kg:","duration":"6-week","effect":"Unlabeled table on page 29: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg","noael_value":"5360","page":29,"route":"","species":"rat","study_id":"sccs_o_039_noael_053"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
% |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=5; DOSE=Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; EFFECT=Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"%","noael_value":"5","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_054"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
% |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=5; DOSE=Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"%","noael_value":"5","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_055"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg |
rat |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=180; DOSE=90 day | Rat | 180 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"90 day | Rat | 180 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg","noael_value":"180","page":29,"route":"","species":"rat","study_id":"sccs_o_039_noael_056"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg |
pig |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=White | m + f | 1500/1000 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"White | m + f | 1500/1000 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":29,"route":"","species":"pig","study_id":"sccs_o_039_noael_057"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg |
dog |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1500; DOSE=Beagle | m + f | 2000/1500 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Beagle | m + f | 2000/1500 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg","noael_value":"1500","page":29,"route":"","species":"dog","study_id":"sccs_o_039_noael_058"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
29.5 |
% |
rat |
- |
2 year |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=29.5; DOSE=No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; EFFECT=Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","duration":"2 year","effect":"Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"%","noael_value":"29.5","page":29,"route":"","species":"rat","study_id":"sccs_o_039_noael_059"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
mouse |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 29: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":29,"route":"oral","species":"mouse","study_id":"sccs_o_039_noael_060"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=1340 |
mg/kg bw/day |
rat |
- |
6-week |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 1340; DOSE=Sprague Dawley | M | 5360 mg/kg:; EFFECT=Unlabeled table on page 29: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Sprague Dawley | M | 5360 mg/kg:","duration":"6-week","effect":"Unlabeled table on page 29: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rat died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1340","page":29,"route":"","species":"rat","study_id":"sccs_o_039_noael_061"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=800 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 800; DOSE=Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; EFFECT=Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 800","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_062"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=250 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 250; DOSE=Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemi in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 250","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_063"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=180 |
mg/kg bw/day |
rat |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 180; DOSE=90 day | Rat | 180 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"90 day | Rat | 180 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 180","page":29,"route":"","species":"rat","study_id":"sccs_o_039_noael_064"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=167 |
mg/kg bw/day |
pig |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 167; DOSE=White | m + f | 1500/1000 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"White | m + f | 1500/1000 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 167","page":29,"route":"","species":"pig","study_id":"sccs_o_039_noael_065"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=400 |
mg/kg bw/day |
dog |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 400; DOSE=Beagle | m + f | 2000/1500 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Beagle | m + f | 2000/1500 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 400","page":29,"route":"","species":"dog","study_id":"sccs_o_039_noael_066"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=200 |
mg/kg bw/day |
rat |
- |
2 year |
- |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 200; DOSE=No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; EFFECT=Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","duration":"2 year","effect":"Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","endpoint":"","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 200","page":29,"route":"","species":"rat","study_id":"sccs_o_039_noael_067"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg bw |
- |
oral |
13 weeks |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1500; DOSE=Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.; EFFECT=n in the kidney. Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was signif; CITATION=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; CITATION_NUMBERS=[34,1000,11]; REFERENCE=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11","dose":"Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.","duration":"13 weeks","effect":"n in the kidney. Slightly lower terminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was signif","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1500","page":24,"route":"oral","species":"","study_id":"sccs_o_119_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw |
- |
oral |
13 weeks |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.; EFFECT=rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly; CITATION=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; CITATION_NUMBERS=[34,1000,11]; REFERENCE=Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11","dose":"rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption.","duration":"13 weeks","effect":"rminal body weights were noted in the 1000 and 2000/1500 mg/kg bw females, but with no correlating decrease in food consumption. Slight, non-adverse findings in clinical pathology parameters were noted in the 400, 1000 and/or 2000/1500 mg/kg bw groups and slightly increased liver weights were observed at 1000 mg/kg bw females and at 2000/1500 mg/kg bw in both sexes. They were considered as an adaptive response rather than a sign of toxicity. Based on the results of this study, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of Transcutol HP for 13 weeks was considered to be at least 1000 mg/kg bw. N Ref.: 34 Comment SCCS notes that the absolute and relative liver weight in the 1000 mg/kg bw/day female group is increased by 11.7% (non-significant) and 22.7% (p= 0.01), respectively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":24,"route":"oral","species":"","study_id":"sccs_o_119_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1340 |
mg/kg bw |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1340; DOSE=t the intermediate dose, one animal died before study termination.; EFFECT=t the intermediate dose, one animal died before study termination. Lethargy was noted during the first week of treatment. There were no significant effects of treatment with the intermediate dose on haematology or clinical chemistries. The relative liver, heart, and kidney weights (but not absolute weights of these organs) were increased with respect to control. Pathological changes included hyperkeratosis of the stomach (2/10), and spleenic congestion (1/9). No effects were noted at the lowest dose; therefore the NOAEL was established as 1340 mg/kg bw. N Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0.4% ethylene glycol; CITATION=Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0; CITATION_NUMBERS=[6,48,12]; REFERENCE=Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0","dose":"t the intermediate dose, one animal died before study termination.","duration":"","effect":"t the intermediate dose, one animal died before study termination. Lethargy was noted during the first week of treatment. There were no significant effects of treatment with the intermediate dose on haematology or clinical chemistries. The relative liver, heart, and kidney weights (but not absolute weights of these organs) were increased with respect to control. Pathological changes included hyperkeratosis of the stomach (2/10), and spleenic congestion (1/9). No effects were noted at the lowest dose; therefore the NOAEL was established as 1340 mg/kg bw. N Ref.: 6, 48 Guideline: / Species/strain: Wistar rats (SPF-derived) Group size: 12 males and 12 females Test substance: DEGEE Batch: / Purity: Contain 0.4% ethylene glycol","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1340","page":24,"route":"","species":"rat","study_id":"sccs_o_119_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
% |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1; DOSE=It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day.; EFFECT=ch was significantly retarded at the 5% level was associated with fall in food consumption. No haematological changes were seen at any dietary level. The raised levels of urinary glutamic-oxaloacetic transaminase which occurred in both sexes at the 5% level indicated impaired renal function. This effect was more pronounced in males which also showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450- 2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% (about 250 and 2500 mg/kg bw/da; CITATION=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; CITATION_NUMBERS=[28,15]; REFERENCE=Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0","dose":"It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day.","duration":"90 days","effect":"ch was significantly retarded at the 5% level was associated with fall in food consumption. No haematological changes were seen at any dietary level. The raised levels of urinary glutamic-oxaloacetic transaminase which occurred in both sexes at the 5% level indicated impaired renal function. This effect was more pronounced in males which also showed a high degree of proteinuria. At the 5% level, increases were observed in the relative weights of the kidney in both sexes and of the testes. It was concluded that the NOAEL corresponded to 1% DEGEE in the diet or about 800 mg/kg bw/day. Ref.: 28 Guideline: / Species/strain: CFE rats (SPF-derived) Group size: 15 males and 15 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 0.5, and 5% DEGEE in the diet; Intake, males 0, 570-260, and 5450- 2710 mg/kg bw/day, females 0, 470-350, and 5000-3560 mg/kg bw/day Route: Oral in diet Exposures: 90 days GLP: / CFE rats, groups of 15 males and females, received 0, 0.5, and 5.0% (about 250 and 2500 mg/kg bw/da","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"1","page":25,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts”; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"","effect":"s, and histopathology. A toxicokinetic analysis were also performed and the results showed that DEGEE was rapidly absorbed after oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts”","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":25,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg bw/d |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=180; DOSE=No significant toxicity were observed after DEGEE treatment at the single dose level tested.; EFFECT=oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts”; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No significant toxicity were observed after DEGEE treatment at the single dose level tested.","duration":"","effect":"oral administration to rats and even if the oral bioavailability of DEGEE could not be determined in this study, it was clear that oral administration of DEGEE resulted in a significant systemic exposure to the compound for up to 8 hours after each exposure in male and female rats. No significant toxicity were observed after DEGEE treatment at the single dose level tested. Therefore, the NOAEL for oral DEGEE treatment is 180 mg/kg bw/d. This value is the one used in the calculation of the safety margin, but a new NOAEL may be chosen if new reliable data are submitted to the experts”","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":25,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
850 |
mg/kg bw/day |
mouse |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=850-1000; DOSE=10 of the 20 males at the high dose died between week 5 and 12.; EFFECT=l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/day. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 167, 500, and 1500 mg/kg bw/day DEGEE, top dose decreased to 1000 mg/kg bw/day after 3 weeks Route: Oral in diet Exposures: 90 days GLP: / Date: 1967 White pigs, groups of 3 males and 3 females (6 weeks old), received 0, 167, 500, and 1500 mg/kg bw/day DEGEE (top dose decreased to 1000 mg/kg bw/day after 3 weeks) in; CITATION=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0; CITATION_NUMBERS=[29,3]; REFERENCE=Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0","dose":"10 of the 20 males at the high dose died between week 5 and 12.","duration":"90 days","effect":"l in diet Exposures: 90 days GLP: / CD-1 mice, groups of 20 males and 20 females, received 0, 0.2, 0.6, 1.8, and 5.4% DEGEE in the diet for 13 weeks. 10 of the 20 males at the high dose died between week 5 and 12. The growth rate was reduced at the highest level of DEGEE. The relative kidney weight was significantly increased in the high dose group (16% male, 18% females) and next high dose among males (16%). Histological examination showed hydropic degeneration of the proximal renal tubules. It is concluded that NOAEL is about 850-1000 mg/kg bw/day. Ref.: 29 Pigs Guideline: / Species/strain: White pigs Group size: 3 males and 3 females Test substance: DEGEE Batch: / Purity: < 0.4% ethylene glycol Dose levels: 0, 167, 500, and 1500 mg/kg bw/day DEGEE, top dose decreased to 1000 mg/kg bw/day after 3 weeks Route: Oral in diet Exposures: 90 days GLP: / Date: 1967 White pigs, groups of 3 males and 3 females (6 weeks old), received 0, 167, 500, and 1500 mg/kg bw/day DEGEE (top dose decreased to 1000 mg/kg bw/day after 3 weeks) in","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"850-1000","page":26,"route":"oral","species":"mouse","study_id":"sccs_o_119_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
167 |
mg/kg bw/day |
pig |
- |
13-week |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=167; DOSE=There was a slight anaemia in male pigs at the highest dose.; EFFECT=g the treatment and increased from about 10 kg to 35 kg during the 13-week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/day (in one of two female pigs). It is concluded that NOAEL was 167 mg/kg bw/day. Ref.: 29 Comment The SCCS notes that the concentration of ethylene glycol is higher than accepted in cosmetic preparations and that the study was not performed according to OECD guidelines and GLP.; CITATION=Ref.: 29 Comment The SCCS notes that the concentration of ethylene glycol is higher than accepted in cosmetic preparations and that the study was not performed according to OECD guidelin; CITATION_NUMBERS=[29]; REFERENCE=Ref.: 29 Comment The SCCS notes that the concentration of ethylene glycol is higher than accepted in cosmetic preparations and that the study was not performed according to OECD guidelin; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Comment The SCCS notes that the concentration of ethylene glycol is higher than accepted in cosmetic preparations and that the study was not performed according to OECD guidelin","dose":"There was a slight anaemia in male pigs at the highest dose.","duration":"13-week","effect":"g the treatment and increased from about 10 kg to 35 kg during the 13-week treatment. There was a slight anaemia in male pigs at the highest dose. The killed pigs had a more severe anaemia associated with a reduced haematocrit and erythrocyte count. The absolute and relative kidney weight was increased in the high dose group. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/day (in one of two female pigs). It is concluded that NOAEL was 167 mg/kg bw/day. Ref.: 29 Comment The SCCS notes that the concentration of ethylene glycol is higher than accepted in cosmetic preparations and that the study was not performed according to OECD guidelines and GLP.","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"167","page":26,"route":"","species":"pig","study_id":"sccs_o_119_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rat |
oral |
30 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:; EFFECT=the kidney are further supported by an old study from 1947 where kidney damage and treatment-related mortality were reported in rabbits following dermal application of DEGEE for 30 day (no further information available). Oral Table 3.10: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:","duration":"30 day","effect":"the kidney are further supported by an old study from 1947 where kidney damage and treatment-related mortality were reported in rabbits following dermal application of DEGEE for 30 day (no further information available). Oral Table 3.10: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":28,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=1340 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 1340; DOSE=Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:; EFFECT=r information available). Oral Table 3.10: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat:","duration":"90 day","effect":"r information available). Oral Table 3.10: Summary on oral repeated toxicity Study Species Sex Effects Critical doses Ref 90 day Mice: CD-1 m + f 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day NOAEL = 850 – 1000 mg/kg bw/day 29 6-week Rat: Sprague Dawley M 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted NOAEL = 1340 mg/kg bw/day N- 6, 48","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1340","page":28,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
800 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=800; DOSE=Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:; EFFECT=SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 29 Study Species Sex Effects Critical doses Ref 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m +; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:","duration":"90 day","effect":"SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 29 Study Species Sex Effects Critical doses Ref 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m +","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"800","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
250 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=250; DOSE=Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:; EFFECT=__________________________________________________________________________ 29 Study Species Sex Effects Critical doses Ref 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:","duration":"90 day","effect":"__________________________________________________________________________ 29 Study Species Sex Effects Critical doses Ref 90 day Rat: Wistar m + f 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=180 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 180; DOSE=Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:; EFFECT=ed. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat:","duration":"90 day","effect":"ed. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day NOAEL = 800 mg/kg bw/day 28 90 day Rat: CFE m + f 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 180","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=167 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 167; DOSE=Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg:; EFFECT=ales and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% e; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg:","duration":"90 day","effect":"ales and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day NOAEL = 250 mg/kg bw/day 29 90 day Rat 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) -- 90 day Pigs: White m + f 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% e","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 167","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=500; DOSE=A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight.; EFFECT=ogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. The concentration of ethylene glycol in this study was higher than accepted in cosmetic preparations and the study was not performed according to OECD guidelines and GLP. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS. However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight.","duration":"90 day","effect":"ogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. The concentration of ethylene glycol in this study was higher than accepted in cosmetic preparations and the study was not performed according to OECD guidelines and GLP. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS. However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
% |
rat |
- |
4 month |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1; EFFECT=SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 30 exposed to 270 and 1100 mg/m3 DEGEE. No system effects were observed. A NOAEL of 90 mg/m3 was found for local effects and 1100 mg/m3 DEGEE for systemic toxicity. SCCS note that the DEGEE used contained 1% ethylene glycol. In a 4 month study where rats were exposed continuously to 1, 5, or 25 mg/m3 DEGEE, the authors reported changes in the functional state of the nervous system were found during both the treatment and the recovery periods in rats. Analysis of blood samples was said to reveal indications of anemia. The authors wrote that the effects were confined mainly to rats exposed to 5; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"","duration":"4 month","effect":"SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 30 exposed to 270 and 1100 mg/m3 DEGEE. No system effects were observed. A NOAEL of 90 mg/m3 was found for local effects and 1100 mg/m3 DEGEE for systemic toxicity. SCCS note that the DEGEE used contained 1% ethylene glycol. In a 4 month study where rats were exposed continuously to 1, 5, or 25 mg/m3 DEGEE, the authors reported changes in the functional state of the nervous system were found during both the treatment and the recovery periods in rats. Analysis of blood samples was said to reveal indications of anemia. The authors wrote that the effects were confined mainly to rats exposed to 5","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"1","page":30,"route":"","species":"rat","study_id":"sccs_o_119_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
- |
rat |
inhalation |
28 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=unclear:g to the ConsExpo fact sheet. Total daily exposure is based on two times 5 minutes and an inhalation rate of 23.1 l/min. See Table 3.12. Table 3.12: Calculation of daily exposure by SCCS Substance Spraying time (s) Amount sprayed (g) Peak concentration (mg/l) Total exposure (mg) Daily exposure (mg/kg bw/d) Fine fragrance 5.0 0.70 0.0026 0.61 0.0101 Hair spray 14.4 6.8 0.0257 5.94 0.0989 Ap/Deo 10 4.0 00151 3.49 0.0582 Total 0.167 The highest peak exposure is calculated to 0.0257 mg/l or 25.7 mg/m3. Since a NOAEL of 90 mg/m3 was found for local effects in rats in a 28 day study with 6 hours exposure per day, it is unlikely that 2 times 5 min exposure per day at 25.7 mg/m3 will produce any adverse effects in humans. 3.3.13. Safety evaluation (including calculation of the MoS) 1 www.consexpo.nl; DOSE=Calculation of daily exposure by SCCS Substance Spraying time (s) Amount sprayed (g) Peak concentration (mg/l) Total exposure (mg) Daily exposure (mg/kg bw/d) Fine fragrance 5.0 0.70 0.0026 0.61 0.0101 Hair spray 14.4 6.8 0.0257 5.94 0.0989 Ap/Deo 10 4.0 00151 3.49 0.0582 Total 0.167 The highest peak exposure is calculated to 0.0257 mg/l or 25.7...; EFFECT=g to the ConsExpo fact sheet. Total daily exposure is based on two times 5 minutes and an inhalation rate of 23.1 l/min. See Table 3.12. Table 3.12: Calculation of daily exposure by SCCS Substance Spraying time (s) Amount sprayed (g) Peak concentration (mg/l) Total exposure (mg) Daily exposure (mg/kg bw/d) Fine fragrance 5.0 0.70 0.0026 0.61 0.0101 Hair spray 14.4 6.8 0.0257 5.94 0.0989 Ap/Deo 10 4.0 00151 3.49 0.0582 Total 0.167 The highest peak exposure is calculated to 0.0257 mg/l or 25.7 mg/m3. Since a NOAEL of 90 mg/m3 was found for local effects in rats in a 28 day study with 6 hours exposure per day, it is unlikely that 2 times 5 min exposure per day at 25.7 mg/m3 will produce any adverse effects in humans. 3.3.13. Safety evaluation (including calculation of the MoS) 1 www.consexpo.nl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Calculation of daily exposure by SCCS Substance Spraying time (s) Amount sprayed (g) Peak concentration (mg/l) Total exposure (mg) Daily exposure (mg/kg bw/d) Fine fragrance 5.0 0.70 0.0026 0.61 0.0101 Hair spray 14.4 6.8 0.0257 5.94 0.0989 Ap/Deo 10 4.0 00151 3.49 0.0582 Total 0.167 The highest peak exposure is calculated to 0.0257 mg/l or 25.7...","duration":"28 day","effect":"g to the ConsExpo fact sheet. Total daily exposure is based on two times 5 minutes and an inhalation rate of 23.1 l/min. See Table 3.12. Table 3.12: Calculation of daily exposure by SCCS Substance Spraying time (s) Amount sprayed (g) Peak concentration (mg/l) Total exposure (mg) Daily exposure (mg/kg bw/d) Fine fragrance 5.0 0.70 0.0026 0.61 0.0101 Hair spray 14.4 6.8 0.0257 5.94 0.0989 Ap/Deo 10 4.0 00151 3.49 0.0582 Total 0.167 The highest peak exposure is calculated to 0.0257 mg/l or 25.7 mg/m3. Since a NOAEL of 90 mg/m3 was found for local effects in rats in a 28 day study with 6 hours exposure per day, it is unlikely that 2 times 5 min exposure per day at 25.7 mg/m3 will produce any adverse effects in humans. 3.3.13. Safety evaluation (including calculation of the MoS) 1 www.consexpo.nl","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"","noael_value":"unclear:g to the ConsExpo fact sheet. Total daily exposure is based on two times 5 minutes and an inhalation rate of 23.1 l/min. See Table 3.12. Table 3.12: Calculation of daily exposure by SCCS Substance Spraying time (s) Amount sprayed (g) Peak concentration (mg/l) Total exposure (mg) Daily exposure (mg/kg bw/d) Fine fragrance 5.0 0.70 0.0026 0.61 0.0101 Hair spray 14.4 6.8 0.0257 5.94 0.0989 Ap/Deo 10 4.0 00151 3.49 0.0582 Total 0.167 The highest peak exposure is calculated to 0.0257 mg/l or 25.7 mg/m3. Since a NOAEL of 90 mg/m3 was found for local effects in rats in a 28 day study with 6 hours exposure per day, it is unlikely that 2 times 5 min exposure per day at 25.7 mg/m3 will produce any adverse effects in humans. 3.3.13. Safety evaluation (including calculation of the MoS) 1 www.consexpo.nl","page":43,"route":"inhalation","species":"rat","study_id":"sccs_o_119_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
102 |
ppm |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=102; DOSE=SCCS considers on the basis of the above experiment the NOAEL of maternal toxicity and teratogenicity 102 ppm (570 mg/m3;; EFFECT=ion days 7 – 15. Females were weighed and euthanized on day 20. The uterus was removed and the numbers of resorption sites and live foetuses were counted. Foetuses were removed, weighed, sexed, and examined for external malformation. Two-thirds of the foetuses were fixed and examined for visceral abnormalities with a dissection microscope. The rest of the foetuses were examined for skeletal defects. Test material did not cause toxicity in dams or in foetuses. SCCS considers on the basis of the above experiment the NOAEL of maternal toxicity and teratogenicity 102 ppm (570 mg/m3; 11.4 mg/kg bw/d) based on no effects at the only dose tested. Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several different unidentified metabolite peaks that accounted for approximately 1-17% of the total radioactivity. Human hepatocytes did not metabolize DEGEE significantly. In vivo, the absorption, distribution and excretion of DEGEE was investiga; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"SCCS considers on the basis of the above experiment the NOAEL of maternal toxicity and teratogenicity 102 ppm (570 mg/m3;","duration":"","effect":"ion days 7 – 15. Females were weighed and euthanized on day 20. The uterus was removed and the numbers of resorption sites and live foetuses were counted. Foetuses were removed, weighed, sexed, and examined for external malformation. Two-thirds of the foetuses were fixed and examined for visceral abnormalities with a dissection microscope. The rest of the foetuses were examined for skeletal defects. Test material did not cause toxicity in dams or in foetuses. SCCS considers on the basis of the above experiment the NOAEL of maternal toxicity and teratogenicity 102 ppm (570 mg/m3; 11.4 mg/kg bw/d) based on no effects at the only dose tested. Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several different unidentified metabolite peaks that accounted for approximately 1-17% of the total radioactivity. Human hepatocytes did not metabolize DEGEE significantly. In vivo, the absorption, distribution and excretion of DEGEE was investiga","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"ppm","noael_value":"102","page":48,"route":"","species":"rat","study_id":"sccs_o_119_noael_061"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5.4 |
% |
mouse |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=5.4; DOSE=Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 28: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 28: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"5.4","page":28,"route":"oral","species":"mouse","study_id":"sccs_o_119_noael_062"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5360 |
mg/kg |
rat |
- |
6-week |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=5360; DOSE=Sprague Dawley | M | 5360 mg/kg:; EFFECT=Unlabeled table on page 28: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Sprague Dawley | M | 5360 mg/kg:","duration":"6-week","effect":"Unlabeled table on page 28: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg","noael_value":"5360","page":28,"route":"","species":"rat","study_id":"sccs_o_119_noael_063"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
mouse |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 28: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 28: 90 day | Mice: CD-1 | m + f | 5.4% in diet: 10 males died 1.8% in diet: Relative kidney weight significantly increased among males. 0.6% in diet: No effects recorded. Corresponds to 850 – 1000 mg/kg bw/day | NOAEL = 850 – 1000 mg/kg bw/day | 29","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":28,"route":"oral","species":"mouse","study_id":"sccs_o_119_noael_064"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=1340 |
mg/kg bw/day |
rat |
- |
6-week |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 1340; DOSE=Sprague Dawley | M | 5360 mg/kg:; EFFECT=Unlabeled table on page 28: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Sprague Dawley | M | 5360 mg/kg:","duration":"6-week","effect":"Unlabeled table on page 28: 6-week | Rat: Sprague Dawley | M | 5360 mg/kg: 4 rats died. 2680 mg/kg: 1 rat died. Relative liver, heart, and kidney weights increased. 1340 mg/kg: No effects noted | NOAEL = 1340 mg/kg bw/day | N- 6, 48","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 1340","page":28,"route":"","species":"rat","study_id":"sccs_o_119_noael_065"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
% |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=5; DOSE=Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; EFFECT=Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"5","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_066"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
% |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=5; DOSE=Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"5","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_067"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
180 |
mg/kg |
rat |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=180; DOSE=90 day | Rat | 180 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"90 day | Rat | 180 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg","noael_value":"180","page":29,"route":"","species":"rat","study_id":"sccs_o_119_noael_068"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg |
pig |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=White | m + f | 1500/1000 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"White | m + f | 1500/1000 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":29,"route":"","species":"pig","study_id":"sccs_o_119_noael_069"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1500 |
mg/kg |
dog |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1500; DOSE=Beagle | m + f | 2000/1500 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Beagle | m + f | 2000/1500 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg","noael_value":"1500","page":29,"route":"","species":"dog","study_id":"sccs_o_119_noael_070"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
29.5 |
% |
rat |
- |
2 year |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=29.5; DOSE=No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; EFFECT=Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","duration":"2 year","effect":"Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"29.5","page":29,"route":"","species":"rat","study_id":"sccs_o_119_noael_071"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=800 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 800; DOSE=Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; EFFECT=Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: Wistar | m + f | 5% in diet: Growth significantly retarded. 1% in diet: No effect recorded. Corresponds to about 800 mg/kg bw/day | NOAEL = 800 mg/kg bw/day | 28","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 800","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_072"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=250 |
mg/kg bw/day |
rat |
oral |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 250; DOSE=Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; EFFECT=Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat: CFE | m + f | 5% in diet: Growth rate reduced. Slight anaemia in males. Relative kidney weigh significantly increased among both males and females. 0.5% in diet: No effects recorded. Corresponded to about 250 mg/kg bw/day | NOAEL = 250 mg/kg bw/day | 29","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 250","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_073"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=180 |
mg/kg bw/day |
rat |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 180; DOSE=90 day | Rat | 180 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"90 day | Rat | 180 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Rat | 180 mg/kg: Study evaluated by French authorities (AFSSAPS in 2005 concluded that no adverse health effects were observed at the single dose tested) | NOAEL = 180 mg/kg bw/day (communication from AFSSAPS) | --","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 180","page":29,"route":"","species":"rat","study_id":"sccs_o_119_noael_074"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=167 |
mg/kg bw/day |
pig |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 167; DOSE=White | m + f | 1500/1000 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"White | m + f | 1500/1000 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Pigs: White | m + f | 1500/1000 mg/kg: 3 pigs had to be killed 500 mg/kg: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded | NOAEL = 167 mg/kg bw/day | 29","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 167","page":29,"route":"","species":"pig","study_id":"sccs_o_119_noael_075"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=400 |
mg/kg bw/day |
dog |
- |
90 day |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 400; DOSE=Beagle | m + f | 2000/1500 mg/kg:; EFFECT=Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Beagle | m + f | 2000/1500 mg/kg:","duration":"90 day","effect":"Unlabeled table on page 29: 90 day | Dog: Beagle | m + f | 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. | NOAEL = 400 mg/kg bw/day | N- 34","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 400","page":29,"route":"","species":"dog","study_id":"sccs_o_119_noael_076"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=200 |
mg/kg bw/day |
rat |
- |
2 year |
- |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 200; DOSE=No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; EFFECT=Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","duration":"2 year","effect":"Unlabeled table on page 29: 2 year | Rat: Albino | m + f | Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. | NOAEL = 200 mg/kg bw/day | 34","endpoint":"","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 200","page":29,"route":"","species":"rat","study_id":"sccs_o_119_noael_077"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
55.2 |
% |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=55.2; DOSE=Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.; EFFECT=Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the u; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.","duration":"2 year","effect":"Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation / 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity / 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the u","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"%","noael_value":"55.2","page":23,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=1.97 |
mg/kg |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 1.97; DOSE=Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.; EFFECT=ALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products). 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.","duration":"2 year","effect":"ALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products). 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg","noael_value":"= 1.97","page":23,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 200; DOSE=Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.; EFFECT=ylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products). 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.","duration":"2 year","effect":"ylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products). 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg","noael_value":"= 200","page":23,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 200; DOSE=Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.; EFFECT=nsidering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products). 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d.","duration":"2 year","effect":"nsidering dermal exposure. Maximum dermal absorption of test substance reported was 55.2% NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97 mg/kg No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products). 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg","noael_value":"= 200","page":23,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
200 |
mg/kg bw/d |
rat |
oral |
- |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=200; DOSE=orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine.; EFFECT=orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Ref.: 48 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200; CITATION=Ref.: 48 3; CITATION_NUMBERS=[48,3]; REFERENCE=Ref.: 48 3; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 48 3","dose":"orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine.","duration":"","effect":"orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Ref.: 48 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":28,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=1.97 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 1.97; DOSE=NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8.; EFFECT=n is only considering dermal exposure. NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8.","duration":"2 year","effect":"n is only considering dermal exposure. NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products).","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 1.97","page":28,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 200; DOSE=NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8.; EFFECT=sure. NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8.","duration":"2 year","effect":"sure. NOAEL based on kidney damage or bladder concretions in albino rats was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products).","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":28,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 200; DOSE=ts was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8.; EFFECT=ts was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ts was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8.","duration":"2 year","effect":"ts was 200 mg/kg bw/d DEGEE in all cosmetic products, except products for oral hygiene and eye products at a concentrations up to 1.5% Dermal absorption 45.6+4.8. Uses mean + 2 SD Exposure 17.79 (total) – 3.52 (oral product) = 14.27 g/d, 1.5% DEGEE = 214 mg/d. Maximum absorption through the skin 214 x 55.2/100 = 118 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 118/60 = 1.97mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 102 A MOS of 102 is considered to give sufficient protection in relation to the use of DEGEE as a solvent in cosmetics (with exception of oral products).","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":28,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.75 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 0.75; DOSE=Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...; EFFECT=SCCP/1200/08 Opinion on diethyleneglycol monoethylether 29 DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations Dermal absorption 34.2+15.0. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 267 A MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...","duration":"2 year","effect":"SCCP/1200/08 Opinion on diethyleneglycol monoethylether 29 DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations Dermal absorption 34.2+15.0. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 267 A MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.75","page":29,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 200; DOSE=Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...; EFFECT=SCCP/1200/08 Opinion on diethyleneglycol monoethylether 29 DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations Dermal absorption 34.2+15.0. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 267 A MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...","duration":"2 year","effect":"SCCP/1200/08 Opinion on diethyleneglycol monoethylether 29 DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations Dermal absorption 34.2+15.0. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 267 A MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body w","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":29,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 200; DOSE=Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...; EFFECT=onoethylether 29 DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations Dermal absorption 34.2+15.0. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 267 A MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...","duration":"2 year","effect":"onoethylether 29 DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations Dermal absorption 34.2+15.0. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 44.9 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.75 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 267 A MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":29,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.2 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 0.20; DOSE=Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...; EFFECT=MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 1000 A MOS of 1000 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCP considers the proposed uses safe for the consumer given the use pattern of hair dyes. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influen; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...","duration":"2 year","effect":"MOS of 267 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 1000 A MOS of 1000 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCP considers the proposed uses safe for the consumer given the use pattern of hair dyes. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influen","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.20","page":29,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 200; DOSE=Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...; EFFECT=ction in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 1000 A MOS of 1000 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCP considers the proposed uses safe for the consumer given the use pattern of hair dyes. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...","duration":"2 year","effect":"ction in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 1000 A MOS of 1000 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCP considers the proposed uses safe for the consumer given the use pattern of hair dyes. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":29,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=200 |
mg/kg bw |
rat |
oral |
2 year |
dermal absorption |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT== 200; DOSE=Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...; EFFECT=e formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 1000 A MOS of 1000 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCP considers the proposed uses safe for the consumer given the use pattern of hair dyes. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 yea...","duration":"2 year","effect":"e formulations. DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations Dermal absorption 9.9+3.8. Uses mean + 2 SD Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 12.3 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.20 mg/kg bw No observed adverse effect level NOAEL = 200 mg/kg bw (albino rats 2 year oral study) Margin of Safety NOAEL / SED = 1000 A MOS of 1000 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCP considers the proposed uses safe for the consumer given the use pattern of hair dyes. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered","endpoint":"dermal absorption","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 200","page":29,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
400 |
mg/kg bw/day |
dog |
dermal |
13 week |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=400; DOSE=NOAEL based on kidney damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products.; EFFECT=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 43 CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. NOAEL based on kidney damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products. Leave-on products A dermal absorption of (56.1 + 12.5) 68.6% is used in the MOS calculations. Exposure 13 g/day, 5.5% DEGEE = 715 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Mar; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL based on kidney damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products.","duration":"13 week","effect":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 43 CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is only considering dermal exposure. NOAEL based on kidney damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products. Leave-on products A dermal absorption of (56.1 + 12.5) 68.6% is used in the MOS calculations. Exposure 13 g/day, 5.5% DEGEE = 715 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Mar","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":43,"route":"dermal","species":"dog","study_id":"sccs_o_039_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=8.2 |
mg/kg bw |
dog |
dermal |
13 week |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 8.2; DOSE=ey damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products.; EFFECT=ey damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products. Leave-on products A dermal absorption of (56.1 + 12.5) 68.6% is used in the MOS calculations. Exposure 13 g/day, 5.5% DEGEE = 715 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGE; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ey damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products.","duration":"13 week","effect":"ey damage in a 13 week study with dogs was 400 mg/kg bw/day The applicant wants to use DEGEE in a concentration up to 5.5% in leave-on products and in a concentration up to 10% in rinse-off products. Leave-on products A dermal absorption of (56.1 + 12.5) 68.6% is used in the MOS calculations. Exposure 13 g/day, 5.5% DEGEE = 715 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGE","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 8.2","page":43,"route":"dermal","species":"dog","study_id":"sccs_o_039_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.08 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 0.08; DOSE=5 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations.; EFFECT=5 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGEE in all cosmetic products (SED 1.97mg/kg bw) would result in a MoS of 203 when compared to the NOAEL of 400 derived from a newly provided study. The use of 10% DEGEE in rinse-off products does not significantly lower this MoS and is not of concern. However, a MOS of 48 is not considered to give sufficient protection in relation t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"5 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations.","duration":"","effect":"5 mg/day Maximum absorption through the skin 715 x 68.6/100 = 490.5 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGEE in all cosmetic products (SED 1.97mg/kg bw) would result in a MoS of 203 when compared to the NOAEL of 400 derived from a newly provided study. The use of 10% DEGEE in rinse-off products does not significantly lower this MoS and is not of concern. However, a MOS of 48 is not considered to give sufficient protection in relation t","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.08","page":43,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
1.5 |
% |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1.5; DOSE=ose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations.; EFFECT=ose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGEE in all cosmetic products (SED 1.97mg/kg bw) would result in a MoS of 203 when compared to the NOAEL of 400 derived from a newly provided study. The use of 10% DEGEE in rinse-off products does not significantly lower this MoS and is not of concern. However, a MOS of 48 is not considered to give sufficient protection in relation to the combined use of DEGEE in the intended concentrations of 5.5% in leave-on and 10% in rinse-off cosmetic products.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations.","duration":"","effect":"ose (SED) 490.5 /60 = 8.2 mg/kg bw Margin of Safety NOAEL / SED = 49 Rinse-off products A dermal absorption of (17.5 + 3.9) 21.4% is used in the MOS calculations. Exposure 0.22 g/day, 10% DEGEE = 22 mg/day Maximum absorption through the skin 22 x 21.4/100 = 4.7 mg/day Typical body weight of human = 60 kg Systemic exposure dose (SED) 4.7 /60 = 0.08 mg/kg bw Margin of Safety NOAEL / SED = 5000 Total exposure 490.5 +4.7 = 495.2 mg/day Systemic exposure dose (SED) 495.2/60 = 8.25 mg/kg bw Margin of Safety NOAEL / SED = 48 The previously assessed use of 1.5% DEGEE in all cosmetic products (SED 1.97mg/kg bw) would result in a MoS of 203 when compared to the NOAEL of 400 derived from a newly provided study. The use of 10% DEGEE in rinse-off products does not significantly lower this MoS and is not of concern. However, a MOS of 48 is not considered to give sufficient protection in relation to the combined use of DEGEE in the intended concentrations of 5.5% in leave-on and 10% in rinse-off cosmetic products.","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"%","noael_value":"1.5","page":43,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.62 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 0.62; DOSE=Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645...; EFFECT=___________________________________________________________________________ 44 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of (34.2 + 2x15.0) 64.2 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645...","duration":"","effect":"___________________________________________________________________________ 44 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of (34.2 + 2x15.0) 64.2 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.62","page":44,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 400; DOSE=Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645...; EFFECT=__________________________________________ 44 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of (34.2 + 2x15.0) 64.2 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typ; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645...","duration":"","effect":"__________________________________________ 44 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of (34.2 + 2x15.0) 64.2 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typ","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 400","page":44,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 400; DOSE=Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645...; EFFECT=___ 44 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of (34.2 + 2x15.0) 64.2 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Syst; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645...","duration":"","effect":"___ 44 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of (34.2 + 2x15.0) 64.2 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Syst","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 400","page":44,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.17 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 0.17; DOSE=Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...; EFFECT=lation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. Discussion The safety has only been evaluated for dermal exposure. The exposure due to pos; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...","duration":"","effect":"lation to the use of DEGEE as a solvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. Discussion The safety has only been evaluated for dermal exposure. The exposure due to pos","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.17","page":44,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 400; DOSE=Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...; EFFECT=olvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. Discussion The safety has only been evaluated for dermal exposure. The exposure due to possible; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...","duration":"","effect":"olvent in oxidative hair dye formulations. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. Discussion The safety has only been evaluated for dermal exposure. The exposure due to possible","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 400","page":44,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 400; DOSE=Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...; EFFECT=ns. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. Discussion The safety has only been evaluated for dermal exposure. The exposure due to possible evaporation of DEGEE, as observed in va; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...","duration":"","effect":"ns. USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of (9.9 + 2x3.8) 17.5 µg/cm² is used in the MOS calculations. Maximum absorption through the skin A (µg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. Discussion The safety has only been evaluated for dermal exposure. The exposure due to possible evaporation of DEGEE, as observed in va","endpoint":"dermal absorption","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 400","page":44,"route":"dermal","species":"human","study_id":"sccs_o_039_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
400 |
mg/kg bw/day |
dog |
oral |
13 week |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=400; DOSE=NOAEL based on kidney damage in a 13 week oral study with dogs was 400 mg/kg bw/day.; EFFECT=kin & hair care products Body lotion 7.82 Face cream 1.54 Hand cream 2.16 Deo non-spray 1.50 Hair styling 0.40 Make-up products Liquid foundation 0.51 Make-up remover 0.50 Eye make-up 0.02 Mascara 0.025 Lipstick 0.06 Eyeliner 0.005 Total leave-on products (products used for the eye are excluded) 14.45 Oral care cosmetics Toothpaste 0.14 Mouthwash 2.16 TOTAL 17.4 CALCULATIONS OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is considering dermal and inhalation exposure. NOAEL based on kidney damage in a 13 week oral study with dogs was 400 mg/kg bw/day. The applicant wants to use DEGEE in a concentration up to 2.6% in all cosmetic products and in a concentration up to 10% in rinse-off products. All cosmetic products (except products for oral hygiene and the eyes) Leave on products Total leave-on products (except products for oral hygiene and the eyes) 14.45 g (see Table 3.13) A dermal absorption of 50.4% is used in the MOS calculations. Exposure 14.45 g/day, 2.6% DEGEE = 376 mg/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL based on kidney damage in a 13 week oral study with dogs was 400 mg/kg bw/day.","duration":"13 week","effect":"kin & hair care products Body lotion 7.82 Face cream 1.54 Hand cream 2.16 Deo non-spray 1.50 Hair styling 0.40 Make-up products Liquid foundation 0.51 Make-up remover 0.50 Eye make-up 0.02 Mascara 0.025 Lipstick 0.06 Eyeliner 0.005 Total leave-on products (products used for the eye are excluded) 14.45 Oral care cosmetics Toothpaste 0.14 Mouthwash 2.16 TOTAL 17.4 CALCULATIONS OF THE MARGIN OF SAFETY Diethylene glycol monoethyl ether (DEGEE) The safety calculation is considering dermal and inhalation exposure. NOAEL based on kidney damage in a 13 week oral study with dogs was 400 mg/kg bw/day. The applicant wants to use DEGEE in a concentration up to 2.6% in all cosmetic products and in a concentration up to 10% in rinse-off products. All cosmetic products (except products for oral hygiene and the eyes) Leave on products Total leave-on products (except products for oral hygiene and the eyes) 14.45 g (see Table 3.13) A dermal absorption of 50.4% is used in the MOS calculations. Exposure 14.45 g/day, 2.6% DEGEE = 376 mg/d","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":44,"route":"oral","species":"dog","study_id":"sccs_o_119_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=3.16 |
mg/kg bw/d |
human |
oral |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 3.16; DOSE=Exposure 14.45 g/day, 2.6% DEGEE = 376 mg/d Maximum absorption through the skin 376x50.4/100 = 189 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 189/60 = 3.16mg/kg bw/d Margin of Safety (leave on products) NOAEL / SED = 127; EFFECT=n up to 10% in rinse-off products. All cosmetic products (except products for oral hygiene and the eyes) Leave on products Total leave-on products (except products for oral hygiene and the eyes) 14.45 g (see Table 3.13) A dermal absorption of 50.4% is used in the MOS calculations. Exposure 14.45 g/day, 2.6% DEGEE = 376 mg/d Maximum absorption through the skin 376x50.4/100 = 189 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 189/60 = 3.16mg/kg bw/d Margin of Safety (leave on products) NOAEL / SED = 127; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Exposure 14.45 g/day, 2.6% DEGEE = 376 mg/d Maximum absorption through the skin 376x50.4/100 = 189 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 189/60 = 3.16mg/kg bw/d Margin of Safety (leave on products) NOAEL / SED = 127","duration":"","effect":"n up to 10% in rinse-off products. All cosmetic products (except products for oral hygiene and the eyes) Leave on products Total leave-on products (except products for oral hygiene and the eyes) 14.45 g (see Table 3.13) A dermal absorption of 50.4% is used in the MOS calculations. Exposure 14.45 g/day, 2.6% DEGEE = 376 mg/d Maximum absorption through the skin 376x50.4/100 = 189 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 189/60 = 3.16mg/kg bw/d Margin of Safety (leave on products) NOAEL / SED = 127","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 3.16","page":44,"route":"oral","species":"human","study_id":"sccs_o_119_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.19 |
mg/kg bw/d |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 0.19; DOSE=Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic ex...; EFFECT=ion of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 45 Rinse-off products Total rinse-of products 0.54 g (see Table 3.13) A dermal absorption of 21.4% is used in the MOS calculations. Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an o; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic ex...","duration":"","effect":"ion of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 45 Rinse-off products Total rinse-of products 0.54 g (see Table 3.13) A dermal absorption of 21.4% is used in the MOS calculations. Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an o","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.19","page":45,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=3.35 |
mg/kg bw/d |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 3.35; DOSE=Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic ex...; EFFECT=nse-of products 0.54 g (see Table 3.13) A dermal absorption of 21.4% is used in the MOS calculations. Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic ex...","duration":"","effect":"nse-of products 0.54 g (see Table 3.13) A dermal absorption of 21.4% is used in the MOS calculations. Exposure 0.54 g/day, 10% DEGEE = 54 mg/d Maximum absorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²)","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 3.35","page":45,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
0.167 |
mg/kg bw/d |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=0.167; DOSE=bsorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin...; EFFECT=bsorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg System; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"bsorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin...","duration":"","effect":"bsorption through the skin 54 x 21.4/100 = 11.6 mg/d Typical body weight of human = 60 kg Systemic exposure dose (SED) 11.6 /60 = 0.19mg/kg bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg System","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.167","page":45,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
3.52 |
mg/kg bw/d |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=3.52; DOSE=g bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)):; EFFECT=g bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"g bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)):","duration":"","effect":"g bw/d Margin of Safety (rinse-off products) NOAEL / SED = 2077 All cosmetic products (dermal exposure, except products for the eyes)) Total dermal systemic exposure dose (3.16 + 0.19) = 3.35 mg/kg bw/d Margin of Safety NOAEL / SED = 119 Inhalation from spray products Systemic exposure dose (2.6% in spray products (see Table 3.12)): 0.167 mg/kg bw/d Margin of Safety NOAEL / SED = 2395 Total dermal and inhalation exposure Total Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"3.52","page":45,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.62 |
mg/kg bw/d |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 0.62; DOSE=Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations.; EFFECT=Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations.","duration":"","effect":"Systemic exposure dose (3.35 + 0.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations.","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.62","page":45,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_044"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw/d |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 400; DOSE=.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations.; EFFECT=.17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":".17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations.","duration":"","effect":".17) 3.52 mg/kg bw/d Margin of Safety NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations.","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 400","page":45,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_045"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw/d |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 400; DOSE=Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 6...; EFFECT=NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 6...","duration":"","effect":"NOAEL / SED = 114 USE of DEGEE as solvent in an on-head concentration up 7.0% in oxidative hair dye formulations A dermal absorption of 64.2 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 64.2 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 37.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.62mg/kg bw/d No observed adverse effect level NOAEL = 400 mg/kg bw/d Margin of Safety NOAEL / SED = 645 A MOS of 645 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations.","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 400","page":45,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_046"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=0.17 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 0.17; DOSE=ermal, spray and oxidative hair dye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations.; EFFECT=ermal, spray and oxidative hair dye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. (If we consider that the exposure from dermal, spray and non-oxidative hair dye 3.52 + 0.17 = 3.69 mg/kg bw/d, resulting in a MOS = 108 Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into considera; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ermal, spray and oxidative hair dye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations.","duration":"","effect":"ermal, spray and oxidative hair dye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. (If we consider that the exposure from dermal, spray and non-oxidative hair dye 3.52 + 0.17 = 3.69 mg/kg bw/d, resulting in a MOS = 108 Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into considera","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.17","page":46,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_047"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 400; DOSE=ye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations.; EFFECT=ye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. (If we consider that the exposure from dermal, spray and non-oxidative hair dye 3.52 + 0.17 = 3.69 mg/kg bw/d, resulting in a MOS = 108 Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations.","duration":"","effect":"ye 3.52 + 0.62 = 4.14 mg/kg bw/d, resulting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. (If we consider that the exposure from dermal, spray and non-oxidative hair dye 3.52 + 0.17 = 3.69 mg/kg bw/d, resulting in a MOS = 108 Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration t","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 400","page":46,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_048"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
dermal absorption |
=400 |
mg/kg bw |
human |
dermal |
- |
dermal absorption |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 400; DOSE=Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...; EFFECT=ting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. (If we consider that the exposure from dermal, spray and non-oxidative hair dye 3.52 + 0.17 = 3.69 mg/kg bw/d, resulting in a MOS = 108 Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. D; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353...","duration":"","effect":"ting in a MOS = 97 USE of DEGEE as solvent in an on-head concentration up 5.0% in non-oxidative hair dye formulations A dermal absorption of 17.5 μg/cm² is used in the MOS calculations. Maximum absorption through the skin A (μg/cm²) = 17.5 µg/cm² Skin Area surface SAS (cm²) = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 10.2 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.17 mg/kg bw No observed adverse effect level NOAEL = 400 mg/kg bw Margin of Safety NOAEL / SED = 2353 A MOS of 2353 gives sufficient protection in relation to the use of DEGEE as a solvent in oxidative hair dye formulations. (If we consider that the exposure from dermal, spray and non-oxidative hair dye 3.52 + 0.17 = 3.69 mg/kg bw/d, resulting in a MOS = 108 Although the consumer may be exposed to DEGEE both from its use in cosmetics in general and in hair dyes formulations, the SCCS considers the proposed uses safe for the consumer taking into consideration the use pattern of hair dyes. 3.3.14. D","endpoint":"dermal absorption","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 400","page":46,"route":"dermal","species":"human","study_id":"sccs_o_119_noael_049"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/d |
- |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.; EFFECT=was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Ref.: 44; CITATION=Ref.: 44; CITATION_NUMBERS=[44]; REFERENCE=Ref.: 44; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 44","dose":"was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.","duration":"","effect":"was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Ref.: 44","endpoint":"developmental toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":21,"route":"","species":"","study_id":"sccp_o_082_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/d |
- |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.; EFFECT=dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Ref.: 44; CITATION=Ref.: 44; CITATION_NUMBERS=[44]; REFERENCE=Ref.: 44; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 44","dose":"dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.","duration":"","effect":"dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Ref.: 44","endpoint":"developmental toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":21,"route":"","species":"","study_id":"sccp_o_082_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/d |
- |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1000; DOSE=was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.; EFFECT=was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.","duration":"","effect":"was restricted to minor skeletal findings which principally included a dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study.","endpoint":"developmental toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":26,"route":"","species":"","study_id":"sccp_o_161_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/d |
- |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=300; DOSE=dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.; EFFECT=dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups.","duration":"","effect":"dose-related increase in the incidence of reduced ossification of cranial bones in the 1000 and 2000 mg/kg bw/d groups. These minor skeleton findings were considered not to be indicative of a teratogenic potential of Transcutol HP, but suggested a selective effect on the developing foetuses in view of the limited maternal toxicity in the high dose group and the absence of an effect on foetal weight. The dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study.","endpoint":"developmental toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":26,"route":"","species":"","study_id":"sccp_o_161_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw |
- |
- |
Prenatal |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=n was not affected at any dose level.; EFFECT=n was not affected at any dose level. Prenatal developmental toxicity occurred at 2000 mg/kg bw in form of minor skeletal findings predominantly in form of a clear and statistically significant increase in the incidence of reduced ossification of cranial bones as an indication of transiently retarded development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission,; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"n was not affected at any dose level.","duration":"Prenatal","effect":"n was not affected at any dose level. Prenatal developmental toxicity occurred at 2000 mg/kg bw in form of minor skeletal findings predominantly in form of a clear and statistically significant increase in the incidence of reduced ossification of cranial bones as an indication of transiently retarded development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission,","endpoint":"developmental toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":34,"route":"","species":"","study_id":"sccs_o_039_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
>2000 |
mg/kg bw |
- |
- |
prenatal |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=>2000; DOSE=There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.; EFFECT=se in the incidence of reduced ossification of cranial bones as an indication of transiently retarded development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission,; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.","duration":"prenatal","effect":"se in the incidence of reduced ossification of cranial bones as an indication of transiently retarded development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission,","endpoint":"developmental toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":">2000","page":34,"route":"","species":"","study_id":"sccs_o_039_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/day |
- |
- |
prenatal |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=300; DOSE=some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.; EFFECT=some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission,; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.","duration":"prenatal","effect":"some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission,","endpoint":"developmental toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":34,"route":"","species":"","study_id":"sccs_o_039_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
rat |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryo-foetal toxicity.; EFFECT=SCCS-rejected applicant NOAEL: SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 37 in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential and was not considered an adverse effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryo-foetal toxicity. 3.3.9. Toxicokinetics 3.3.9. 1. In vitro metabolism Guideline: / Test system: Hepatocytes from rats and human Test substance: Non-labelled: Transcutol HP (DEGEE), ethylene glycol mono ethyl ether (EGEE) Labelled: [14C]-Diethylene glycol monoethyl ether ([14C]-DEGEE), [14C]-Ethylene glycol monoethyl ether ([14C]-EGEE) Batch: Non-labelled: DEGEE: 0025005, EGEE: 049H1248 Labelled: [14C]-DEGEE: 209-201-053 (radiochemical purity: 100%), [14C]-EGEE: 209-209-053 (radiochemic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryo-foetal toxicity.","duration":"","effect":"SCCS-rejected applicant NOAEL: SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 37 in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential and was not considered an adverse effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryo-foetal toxicity. 3.3.9. Toxicokinetics 3.3.9. 1. In vitro metabolism Guideline: / Test system: Hepatocytes from rats and human Test substance: Non-labelled: Transcutol HP (DEGEE), ethylene glycol mono ethyl ether (EGEE) Labelled: [14C]-Diethylene glycol monoethyl ether ([14C]-DEGEE), [14C]-Ethylene glycol monoethyl ether ([14C]-EGEE) Batch: Non-labelled: DEGEE: 0025005, EGEE: 049H1248 Labelled: [14C]-DEGEE: 209-201-053 (radiochemical purity: 100%), [14C]-EGEE: 209-209-053 (radiochemic","endpoint":"developmental toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":37,"route":"","species":"rat","study_id":"sccs_o_039_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/day |
rat |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=300; DOSE=ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption.; EFFECT=SCCS-rejected applicant NOAEL: ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several differen; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption.","duration":"","effect":"SCCS-rejected applicant NOAEL: ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several differen","endpoint":"developmental toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":46,"route":"","species":"rat","study_id":"sccs_o_039_noael_048"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
rat |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=station was not affected at any dose level.; EFFECT=SCCS-rejected applicant NOAEL: station was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several different unidentified metabolite peaks that accounted for approximately 1-17% of the total radioactivity. Human hepatocytes did n; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"station was not affected at any dose level.","duration":"","effect":"SCCS-rejected applicant NOAEL: station was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several different unidentified metabolite peaks that accounted for approximately 1-17% of the total radioactivity. Human hepatocytes did n","endpoint":"developmental toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":46,"route":"","species":"rat","study_id":"sccs_o_039_noael_049"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
rat |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity.; EFFECT=SCCS-rejected applicant NOAEL: ed to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several different unidentified metabolite peaks that accounted for approximately 1-17% of the total radioactivity. Human hepatocytes did not metabolize DEGEE significantly. In vivo, the absorption, distribution and excretion of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity.","duration":"","effect":"SCCS-rejected applicant NOAEL: ed to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Toxicokinetics and metabolism An in vitro metabolism study to determine its metabolism profile, DEGEE was slowly metabolized by rat hepatocytes to several different unidentified metabolite peaks that accounted for approximately 1-17% of the total radioactivity. Human hepatocytes did not metabolize DEGEE significantly. In vivo, the absorption, distribution and excretion of","endpoint":"developmental toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":46,"route":"","species":"rat","study_id":"sccs_o_039_noael_050"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw |
- |
- |
prenatal |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.; EFFECT=SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 35 development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/k; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.","duration":"prenatal","effect":"SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 35 development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/k","endpoint":"developmental toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":35,"route":"","species":"","study_id":"sccs_o_119_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/day |
rat |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=300; DOSE=ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption.; EFFECT=SCCS-rejected applicant NOAEL: ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofoetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Males rats (>300g) were individually placed in cages with three females (200-300 g). The presence of sperm in vaginal smears was considered day 0 of gestation. Pregn; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption.","duration":"","effect":"SCCS-rejected applicant NOAEL: ation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofoetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Males rats (>300g) were individually placed in cages with three females (200-300 g). The presence of sperm in vaginal smears was considered day 0 of gestation. Pregn","endpoint":"developmental toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":48,"route":"","species":"rat","study_id":"sccs_o_119_noael_058"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
rat |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=station was not affected at any dose level.; EFFECT=SCCS-rejected applicant NOAEL: station was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofoetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Males rats (>300g) were individually placed in cages with three females (200-300 g). The presence of sperm in vaginal smears was considered day 0 of gestation. Pregnant females were caged alone. 20 pregnant animals were exposed to 570 mg/m3 DEGEE 7 hr/day on gestation days 7 – 15. Femal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"station was not affected at any dose level.","duration":"","effect":"SCCS-rejected applicant NOAEL: station was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofoetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Males rats (>300g) were individually placed in cages with three females (200-300 g). The presence of sperm in vaginal smears was considered day 0 of gestation. Pregnant females were caged alone. 20 pregnant animals were exposed to 570 mg/m3 DEGEE 7 hr/day on gestation days 7 – 15. Femal","endpoint":"developmental toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":48,"route":"","species":"rat","study_id":"sccs_o_119_noael_059"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
rat |
- |
- |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity.; EFFECT=SCCS-rejected applicant NOAEL: ed to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofoetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Males rats (>300g) were individually placed in cages with three females (200-300 g). The presence of sperm in vaginal smears was considered day 0 of gestation. Pregnant females were caged alone. 20 pregnant animals were exposed to 570 mg/m3 DEGEE 7 hr/day on gestation days 7 – 15. Females were weighed and euthanized on day 20. The uterus was removed and the numbers of resorpt; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity.","duration":"","effect":"SCCS-rejected applicant NOAEL: ed to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential. The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofoetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study Males rats (>300g) were individually placed in cages with three females (200-300 g). The presence of sperm in vaginal smears was considered day 0 of gestation. Pregnant females were caged alone. 20 pregnant animals were exposed to 570 mg/m3 DEGEE 7 hr/day on gestation days 7 – 15. Females were weighed and euthanized on day 20. The uterus was removed and the numbers of resorpt","endpoint":"developmental toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":48,"route":"","species":"rat","study_id":"sccs_o_119_noael_060"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
200 |
mg/kg bw/d |
rat |
oral |
chronic |
genotoxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=200; DOSE=SCCP/1044/06 OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE) 19 From a two year chronic drinking water study with albino rats, a NOAEL of 200 mg/kg bw/d was obtained with a preparation containing 0.2% ethylene glycol.; EFFECT=SCCP/1044/06 OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE) 19 From a two year chronic drinking water study with albino rats, a NOAEL of 200 mg/kg bw/d was obtained with a preparation containing 0.2% ethylene glycol. This value will be used in calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro DEGEE displayed a weak mutagenic activity at high concentrations in some tested Salmonella typhimurium strains (TA1535, TA1537, TA1538) and in Saccharomyces cervisiae (D7) Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Ba; CITATION=Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Ba; CITATION_NUMBERS=[1,98,100,102,1535,1537]; REFERENCE=Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Ba; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Ba","dose":"SCCP/1044/06 OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE) 19 From a two year chronic drinking water study with albino rats, a NOAEL of 200 mg/kg bw/d was obtained with a preparation containing 0.2% ethylene glycol.","duration":"chronic","effect":"SCCP/1044/06 OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE) 19 From a two year chronic drinking water study with albino rats, a NOAEL of 200 mg/kg bw/d was obtained with a preparation containing 0.2% ethylene glycol. This value will be used in calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro DEGEE displayed a weak mutagenic activity at high concentrations in some tested Salmonella typhimurium strains (TA1535, TA1537, TA1538) and in Saccharomyces cervisiae (D7) Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Ba","endpoint":"genotoxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":19,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
200 |
mg/kg bw/d |
rat |
oral |
chronic |
genotoxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=200; DOSE=SCCP/1200/08 Opinion on diethyleneglycol monoethylether 24 examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.; EFFECT=SCCP/1200/08 Opinion on diethyleneglycol monoethylether 24 examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. From a two year chronic drinking water study with albino rats, a NOAEL of 200 mg/kg bw/d was obtained with a preparation containing 0.2% ethylene glycol. This value will be used in calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro DEGEE displayed a weak mutagenic activity at high concentrations in some tested Salmonella typhimurium strains (TA1535, TA1537, TA1538) and in Saccharomyces cervisiae (D7) Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Bat; CITATION=Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Bat; CITATION_NUMBERS=[1,98,100,102,1535,1537]; REFERENCE=Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Bat; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Bat","dose":"SCCP/1200/08 Opinion on diethyleneglycol monoethylether 24 examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.","duration":"chronic","effect":"SCCP/1200/08 Opinion on diethyleneglycol monoethylether 24 examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. From a two year chronic drinking water study with albino rats, a NOAEL of 200 mg/kg bw/d was obtained with a preparation containing 0.2% ethylene glycol. This value will be used in calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro DEGEE displayed a weak mutagenic activity at high concentrations in some tested Salmonella typhimurium strains (TA1535, TA1537, TA1538) and in Saccharomyces cervisiae (D7) Ref.: 1 Guideline: / Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Bat","endpoint":"genotoxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":24,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
400 |
mg/kg bw/day |
dog |
- |
13 week |
genotoxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=400; DOSE=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 46 decided to use the 13 week dog study from 2007 with a NOAEL of 400 mg/kg bw/day in the calculation of MOS.; EFFECT=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 46 decided to use the 13 week dog study from 2007 with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. Mutagenicity/Genotoxicity DEGEE was tested for mutagenicity/genotoxicity in a range of validated and/or scientifically reasonable studies in vitro and in vivo. No genotoxic/mutagenic potential was noted in reliable bacterial gene mutation assays in vitro with Salmonella typhimurium in the presence or absence of metabolic activation. In vivo, DEGEE did not possess a mutagenic/genotoxic potential covering two independent endpoints. No indication of clastogenicity was; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 46 decided to use the 13 week dog study from 2007 with a NOAEL of 400 mg/kg bw/day in the calculation of MOS.","duration":"13 week","effect":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 46 decided to use the 13 week dog study from 2007 with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. Mutagenicity/Genotoxicity DEGEE was tested for mutagenicity/genotoxicity in a range of validated and/or scientifically reasonable studies in vitro and in vivo. No genotoxic/mutagenic potential was noted in reliable bacterial gene mutation assays in vitro with Salmonella typhimurium in the presence or absence of metabolic activation. In vivo, DEGEE did not possess a mutagenic/genotoxic potential covering two independent endpoints. No indication of clastogenicity was","endpoint":"genotoxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":46,"route":"","species":"dog","study_id":"sccs_o_039_noael_045"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
400 |
mg/kg bw/day |
rat |
oral |
13 week |
genotoxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=400; DOSE=A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs.; EFFECT=e of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose only inhalation study which rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats exposed to 270 or 1100 mg/m³. Thus, a NOAEL of 90 mg/m³ was found for local effects and 1100 mg/m³ DEGEE for systemic toxicity. The SCCS notes that the DEGEE used contained 1% ethylene glycol. Mutagenicity/Gen; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs.","duration":"13 week","effect":"e of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose only inhalation study which rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats exposed to 270 or 1100 mg/m³. Thus, a NOAEL of 90 mg/m³ was found for local effects and 1100 mg/m³ DEGEE for systemic toxicity. The SCCS notes that the DEGEE used contained 1% ethylene glycol. Mutagenicity/Gen","endpoint":"genotoxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":47,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_054"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
1 |
% |
rat |
oral |
2 year |
genotoxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1; DOSE=For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS.; EFFECT=/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose only inhalation study which rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats exposed to 270 or 1100 mg/m³. Thus, a NOAEL of 90 mg/m³ was found for local effects and 1100 mg/m³ DEGEE for systemic toxicity. The SCCS notes that the DEGEE used contained 1% ethylene glycol. Mutagenicity/Genotoxicity DEGEE was tested for mutagenicity/genotoxicity in a range of validated and/or scientifically reasonable studies in vitro and in vivo. No genotoxic/mutagenic potential was noted in reliable bacterial gene mutation assays in vitro with Salmonella typhimurium in the presence or absence of metabolic activation. In vivo, DEGEE did not possess a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS.","duration":"2 year","effect":"/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose only inhalation study which rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats exposed to 270 or 1100 mg/m³. Thus, a NOAEL of 90 mg/m³ was found for local effects and 1100 mg/m³ DEGEE for systemic toxicity. The SCCS notes that the DEGEE used contained 1% ethylene glycol. Mutagenicity/Genotoxicity DEGEE was tested for mutagenicity/genotoxicity in a range of validated and/or scientifically reasonable studies in vitro and in vivo. No genotoxic/mutagenic potential was noted in reliable bacterial gene mutation assays in vitro with Salmonella typhimurium in the presence or absence of metabolic activation. In vivo, DEGEE did not possess a","endpoint":"genotoxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"1","page":47,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_055"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
180 |
mg/kg bw/day |
rat |
oral |
- |
irritation |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=180 to 800; DOSE=In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded.; EFFECT=g bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and sl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded.","duration":"","effect":"g bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and sl","endpoint":"irritation","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180 to 800","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
180 |
mg/kg bw/day |
rat |
oral |
- |
irritation |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=180 to 800; DOSE=French authorities used this study for their NOAEL of 180 mg/kg bw/d.; EFFECT=French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"French authorities used this study for their NOAEL of 180 mg/kg bw/d.","duration":"","effect":"French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE i","endpoint":"irritation","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"180 to 800","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
167 |
mg/kg bw/d |
rat |
oral |
- |
irritation |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=167; DOSE=added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded.; EFFECT=added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded.","duration":"","effect":"added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to c","endpoint":"irritation","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"167","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
98.6 |
% |
rat |
inhalation |
5 days |
irritation |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=98.6; DOSE=e Dawley rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed.; EFFECT=e Dawley rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats (numbers were not stated) and foci of necrosis in the small ventral cartilage of the larynx were observed in 2/5 and 3/5 males inhaling 270 or 1100 mg/m³, respectively. At 1100 mg/m³ the test atmosphere was approximately equally divided by mass into respirable droplets (aerosol) and vapour. The NOAEL from this study for systemic toxicity was determined to be 1100 mg/m³. It is stated that DEGEE was 98.6% pure. Impurities included ethylene glycol (1%) and ethyl glycol (0.24%).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"e Dawley rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed.","duration":"5 days","effect":"e Dawley rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats (numbers were not stated) and foci of necrosis in the small ventral cartilage of the larynx were observed in 2/5 and 3/5 males inhaling 270 or 1100 mg/m³, respectively. At 1100 mg/m³ the test atmosphere was approximately equally divided by mass into respirable droplets (aerosol) and vapour. The NOAEL from this study for systemic toxicity was determined to be 1100 mg/m³. It is stated that DEGEE was 98.6% pure. Impurities included ethylene glycol (1%) and ethyl glycol (0.24%).","endpoint":"irritation","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"98.6","page":21,"route":"inhalation","species":"rat","study_id":"sccs_o_119_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
200 |
mg/kg bw/day |
rat |
oral |
13 week |
irritation |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=200; DOSE=the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found.; EFFECT=the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose only inhalation study which rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats exposed to 270 or 1100 mg/m³; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found.","duration":"13 week","effect":"the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose only inhalation study which rats inhaled 16, 49, or 200 ppm (90, 270, 1100 mg/m³) DEGEE for 6 hours/day, 5 days/week, no systemic effects were observed. However, mild local irritation of the larynx and nasal turbinates were found in some rats exposed to 270 or 1100 mg/m³","endpoint":"irritation","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":47,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_053"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
13 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=250; DOSE=At terminal haematological examination there was a slight anaemia in male rats in the high dose group.; EFFECT=he diet for 13 weeks. At both levels of treatment the rats appeared healthy and there were no deaths. The growth rate was reduced at the highest level of DEGEE. At terminal haematological examination there was a slight anaemia in male rats in the high dose group. The relative kidney weight was significantly increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/d. Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref.: 28, 29) referred to a 90 day rat subchronic gavage study (ref.: 30). This study has not been submitted. It is stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption,; CITATION=Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref; CITATION_NUMBERS=[29]; REFERENCE=Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref","dose":"At terminal haematological examination there was a slight anaemia in male rats in the high dose group.","duration":"13 weeks","effect":"he diet for 13 weeks. At both levels of treatment the rats appeared healthy and there were no deaths. The growth rate was reduced at the highest level of DEGEE. At terminal haematological examination there was a slight anaemia in male rats in the high dose group. The relative kidney weight was significantly increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/d. Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref.: 28, 29) referred to a 90 day rat subchronic gavage study (ref.: 30). This study has not been submitted. It is stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption,","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":16,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
800 |
mg/kg bw/d |
rat |
oral |
23 months |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=800; DOSE=1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.; EFFECT=4 Rats and mice In an incomplete study DEGEE caused no apparent adverse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOA; CITATION=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; CITATION_NUMBERS=[1,490,2960,9]; REFERENCE=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months","dose":"1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.","duration":"23 months","effect":"4 Rats and mice In an incomplete study DEGEE caused no apparent adverse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOA","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"800","page":18,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
23 months |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=250; DOSE=1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.; EFFECT=erse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed; CITATION=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; CITATION_NUMBERS=[1,490,2960,9]; REFERENCE=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months","dose":"1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.","duration":"23 months","effect":"erse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":18,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
180 |
mg/kg bw/d |
rat |
oral |
9 months |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=180; DOSE=s ranging from 490 to 2960 mg mg/kg bw/d for 9 months.; EFFECT=s ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.; CITATION=Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed; CITATION_NUMBERS=[37]; REFERENCE=Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed","dose":"s ranging from 490 to 2960 mg mg/kg bw/d for 9 months.","duration":"9 months","effect":"s ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":18,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=nt Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"nt Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":18,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
800 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=800; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=r produces little repro- or haemato-toxicity, which are of concern with several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar st; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"r produces little repro- or haemato-toxicity, which are of concern with several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar st","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"800","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=250; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=ith several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 m; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"ith several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 m","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
180 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=180; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from severa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from severa","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
180 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=180; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=cute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"cute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. A NOAEL of 200 mg/kg bw/d was calculated from a two year drinking water study with rats. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
13 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=250; DOSE=At terminal haematological examination there was a slight anaemia in male rats in the high dose group.; EFFECT=he diet for 13 weeks. At both levels of treatment the rats appeared healthy and there were no deaths. The growth rate was reduced at the highest level of DEGEE. At terminal haematological examination there was a slight anaemia in male rats in the high dose group. The relative kidney weight was significantly increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/d. Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref.: 28, 29) referred to a 90 day rat subchronic gavage study (ref.: 30). This study has not been submitted. It is stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption,; CITATION=Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref; CITATION_NUMBERS=[29]; REFERENCE=Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref","dose":"At terminal haematological examination there was a slight anaemia in male rats in the high dose group.","duration":"13 weeks","effect":"he diet for 13 weeks. At both levels of treatment the rats appeared healthy and there were no deaths. The growth rate was reduced at the highest level of DEGEE. At terminal haematological examination there was a slight anaemia in male rats in the high dose group. The relative kidney weight was significantly increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/d. Ref.: 29 Comment In the documentation received, it is in addition to the two studies above (ref.: 28, 29) referred to a 90 day rat subchronic gavage study (ref.: 30). This study has not been submitted. It is stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption,","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":21,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
800 |
mg/kg bw/d |
rat |
oral |
23 months |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=800; DOSE=1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.; EFFECT=34 Rats and mice In an incomplete study DEGEE caused no apparent adverse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOA; CITATION=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; CITATION_NUMBERS=[1,490,2960,9]; REFERENCE=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months","dose":"1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.","duration":"23 months","effect":"34 Rats and mice In an incomplete study DEGEE caused no apparent adverse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOA","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"800","page":23,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
23 months |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=250; DOSE=1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.; EFFECT=verse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological; CITATION=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; CITATION_NUMBERS=[1,490,2960,9]; REFERENCE=Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months","dose":"1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months.","duration":"23 months","effect":"verse effects when presented at 1% concentration in the drinking water to rats or mice for up to 23 months. Ref.: 1 Ferrets Ferrets showed no adverse treatment related effects following dietary feeding with DEGEE at concentrations ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
180 |
mg/kg bw/d |
rat |
oral |
9 months |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=180; DOSE=ns ranging from 490 to 2960 mg mg/kg bw/d for 9 months.; EFFECT=ns ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological; CITATION=Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed; CITATION_NUMBERS=[37]; REFERENCE=Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed","dose":"ns ranging from 490 to 2960 mg mg/kg bw/d for 9 months.","duration":"9 months","effect":"ns ranging from 490 to 2960 mg mg/kg bw/d for 9 months. Ref.: 37 General comment Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":23,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1000; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=nt Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"nt Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In an oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar small study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":23,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
800 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=800; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=r produces little repro- or haemato-toxicity, which are of concern with several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"r produces little repro- or haemato-toxicity, which are of concern with several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 1","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"800","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=250; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=ith several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"ith several other glycol ethers. However, some systemic toxicity has been reported. DEGEE may contain ethylene glycol as impurity. It is recommended that the level of ethylene glycol in DEGEE preparations used in cosmetics should be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropi","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
180 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=180; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"be <0.2%. DEGEE has low acute toxicity by oral, dermal, and inhalation routes. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"180","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
mg/kg bw/d |
rat |
oral |
subchronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1000; DOSE=In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.; EFFECT=s. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded.","duration":"subchronic","effect":"s. Three oral subchronic oral studies in rats are discussed. DEGEE was added to the diet in two of the studies. In one study with Wistar rats a NOAEL of 800 mg/kg bw/d was reported and in a study with CFE rats a NOAEL of 250 mg/kg bw/d (0.5% DEGEE in the diet) was concluded. In the third study the rats received DEGEE by gavage. No significant effects were observed at the only dose tested. The French authorities used this study for their NOAEL of 180 mg/kg bw/d. In a oral mice study with DEGEE added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d w","endpoint":"repeated dose toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
400 |
mg/kg bw/day |
- |
- |
- |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=400; DOSE=Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01).; EFFECT=tively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly decreased among males in all groups (p = 0.01), but not among females. Urine creatinine was significantly decreased among all groups of males (p = 0.01) and in the 1000 mg/kg bw/day and the 2000/1500 mg/kg bw/day groups of females (p = 0.01). The SCCS considers 400 mg/kg bw/day to be the NOAEL of this repeated dose study.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01).","duration":"","effect":"tively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly decreased among males in all groups (p = 0.01), but not among females. Urine creatinine was significantly decreased among all groups of males (p = 0.01) and in the 1000 mg/kg bw/day and the 2000/1500 mg/kg bw/day groups of females (p = 0.01). The SCCS considers 400 mg/kg bw/day to be the NOAEL of this repeated dose study.","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":24,"route":"","species":"","study_id":"sccs_o_039_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/day |
rat |
oral |
90 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=250; DOSE=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 26 increased in the high dose group (14% male, 16% females).; EFFECT=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 26 increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/day. Ref.: 29 Comment A 90 day rat subchronic gavage study (ref.: 30) has been evaluated by the French authorities (this study has not been submitted to SCCS). The French authorities stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption, ophthalmology, clinical chem; CITATION=Ref.: 29 Comment A 90 day rat subchronic gavage study (ref; CITATION_NUMBERS=[29,90]; REFERENCE=Ref.: 29 Comment A 90 day rat subchronic gavage study (ref; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Comment A 90 day rat subchronic gavage study (ref","dose":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 26 increased in the high dose group (14% male, 16% females).","duration":"90 day","effect":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 26 increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/day. Ref.: 29 Comment A 90 day rat subchronic gavage study (ref.: 30) has been evaluated by the French authorities (this study has not been submitted to SCCS). The French authorities stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption, ophthalmology, clinical chem","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":26,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
=400 |
mg/kg bw/day |
rat |
oral |
90 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 400; DOSE=No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog:; EFFECT=g: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog:","duration":"90 day","effect":"g: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carr","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 400","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
=200 |
mg/kg bw/day |
rat |
oral |
2 year |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT== 200; DOSE=NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:; EFFECT=t) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:","duration":"2 year","effect":"t) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 200","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
mg/kg bw/day |
rat |
oral |
2 year |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:; EFFECT=and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:","duration":"2 year","effect":"and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":29,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
400 |
mg/kg bw/day |
dog |
- |
13 week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=400; DOSE=In this study, liver changes were observed at 1000 mg/kg bw/day.; EFFECT=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 30 However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according to modern guidelines and with high purity DEGEE (purity >99.9%). In this study, liver changes were observed at 1000 mg/kg bw/day. Based on the results of this study the SCCS considered the NOAEL for repeated dose toxicity to be 400 mg/kg bw/day, which will be used in the calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro DEGEE displayed a weak mutagenic activity at high concentrations in some tested Salmonella typhimurium strains (TA1535, TA1537, TA1538) and in Saccharomyces cervisiae (D7) Ref.: 1 Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Batch: 9833703 (Purity > 99.7; CITATION=Ref.: 1 Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Batch: 9833703 (Purity > 99; CITATION_NUMBERS=[1,471,98,100,102,1535,1537,9833,703,99]; REFERENCE=Ref.: 1 Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Batch: 9833703 (Purity > 99; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 1 Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Batch: 9833703 (Purity > 99","dose":"In this study, liver changes were observed at 1000 mg/kg bw/day.","duration":"13 week","effect":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 30 However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according to modern guidelines and with high purity DEGEE (purity >99.9%). In this study, liver changes were observed at 1000 mg/kg bw/day. Based on the results of this study the SCCS considered the NOAEL for repeated dose toxicity to be 400 mg/kg bw/day, which will be used in the calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro DEGEE displayed a weak mutagenic activity at high concentrations in some tested Salmonella typhimurium strains (TA1535, TA1537, TA1538) and in Saccharomyces cervisiae (D7) Ref.: 1 Guideline: OECD 471 Species/strains: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Test substance: Transcutol P Batch: 9833703 (Purity > 99.7","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":30,"route":"","species":"dog","study_id":"sccs_o_039_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
mg/kg bw/day |
rat |
oral |
- |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.; EFFECT=ation. The total recovery was 100%. In the MOS calculation 64.2 µg/cm² (mean + 2SD) is used for the oxidative hair dye formulation and 17.5 µg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been resolved. Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.","duration":"","effect":"ation. The total recovery was 100%. In the MOS calculation 64.2 µg/cm² (mean + 2SD) is used for the oxidative hair dye formulation and 17.5 µg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been resolved. Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP c","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":45,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
167 |
mg/kg bw/day |
rat |
oral |
13 week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=167; DOSE=Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.; EFFECT=(mean + 2SD) is used for the oxidative hair dye formulation and 17.5 µg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been resolved. Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (S; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.","duration":"13 week","effect":"(mean + 2SD) is used for the oxidative hair dye formulation and 17.5 µg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been resolved. Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (S","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"167","page":45,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
400 |
mg/kg bw/day |
rat |
oral |
13 week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=400; DOSE=Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.; EFFECT=he large difference has not been resolved. Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.","duration":"13 week","effect":"he large difference has not been resolved. Repeated dose toxicity In five rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS","endpoint":"repeated dose toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":45,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1 |
% |
rat |
oral |
12 days |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1; EFFECT=SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 22 Ref.: 26 Comment A NOAEL of 90 mg/m3 was found for local effects and 1100 mg/m3 DEGEE for systemic toxicity. SCCS note that the DEGEE used contained 1% ethylene glycol. Mice, rats, guinea pigs, rabbits, and cats Daily exposure of mice, rats, guinea pigs, rabbits, and cats to an atmosphere saturated with DEGEE for 12 days was reported not to cause adverse effect. Ref.: 27 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Oral Dogs Guideline/method: Subchronic oral toxicity study according to pharmaceutical guideline (FDA) excee; CITATION=Ref.: 26 Comment A NOAEL of 90 mg/m3 was found for local effects and 1100 mg/m3 DEGEE for systemic toxicity; CITATION_NUMBERS=[26,90,3,1100]; REFERENCE=Ref.: 26 Comment A NOAEL of 90 mg/m3 was found for local effects and 1100 mg/m3 DEGEE for systemic toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment A NOAEL of 90 mg/m3 was found for local effects and 1100 mg/m3 DEGEE for systemic toxicity","dose":"","duration":"12 days","effect":"SCCS/1507/13 Revision of the opinion on diethylene glycol monoethyl ether ___________________________________________________________________________________________ 22 Ref.: 26 Comment A NOAEL of 90 mg/m3 was found for local effects and 1100 mg/m3 DEGEE for systemic toxicity. SCCS note that the DEGEE used contained 1% ethylene glycol. Mice, rats, guinea pigs, rabbits, and cats Daily exposure of mice, rats, guinea pigs, rabbits, and cats to an atmosphere saturated with DEGEE for 12 days was reported not to cause adverse effect. Ref.: 27 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Oral Dogs Guideline/method: Subchronic oral toxicity study according to pharmaceutical guideline (FDA) excee","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"%","noael_value":"1","page":22,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
400 |
mg/kg bw/day |
rat |
oral |
- |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=400; DOSE=Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01).; EFFECT=tively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly decreased among males in all groups (p = 0.01), but not among females. Urine creatinine was significantly decreased among all groups of males (p = 0.01) and in the 1000 mg/kg bw/day and the 2000/1500 mg/kg bw/day groups of females (p = 0.01). The SCCS considers 400 mg/kg bw/day to be the NOAEL of this repeated dose study. Rats A six week oral gavage study was conducted in which groups of 10 male Sprague Dawley rats were administered doses of 1340, 2680, and 5360 mg/kg bw/day DEGEE. At the highest dose, four animals died before study termination and 3 were terminated moribund. Seven animals had bloody urine at various times throughout the study. Several other haematological and clinical chemistry signs were observed. At the intermediate dose, one animal died before study termination. Lethargy was note; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01).","duration":"","effect":"tively. Alkaline phosphatase was significantly increased both among males (p = 0.01) and females (p = 0.05) in the 1000 mg/kg bw/day groups as well as in the high dose groups (p = 0.01). Urine sodium and chloride was significantly decreased among males in all groups (p = 0.01), but not among females. Urine creatinine was significantly decreased among all groups of males (p = 0.01) and in the 1000 mg/kg bw/day and the 2000/1500 mg/kg bw/day groups of females (p = 0.01). The SCCS considers 400 mg/kg bw/day to be the NOAEL of this repeated dose study. Rats A six week oral gavage study was conducted in which groups of 10 male Sprague Dawley rats were administered doses of 1340, 2680, and 5360 mg/kg bw/day DEGEE. At the highest dose, four animals died before study termination and 3 were terminated moribund. Seven animals had bloody urine at various times throughout the study. Several other haematological and clinical chemistry signs were observed. At the intermediate dose, one animal died before study termination. Lethargy was note","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":24,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
250 |
mg/kg bw/day |
rat |
oral |
13 weeks |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=250; DOSE=At terminal haematological examination there was a slight anaemia in male rats in the high dose group.; EFFECT=he diet for 13 weeks. At both levels of treatment the rats appeared healthy and there were no deaths. The growth rate was reduced at the highest level of DEGEE. At terminal haematological examination there was a slight anaemia in male rats in the high dose group. The relative kidney weight was significantly increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/day. Ref.: 29 Comment A 90 day rat subchronic gavage study (ref.: 30) has been evaluated by the French authorities (this study has not been submitted to SCCS). The French authorities stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption, ophthalmology, clinical chem; CITATION=Ref.: 29 Comment A 90 day rat subchronic gavage study (ref; CITATION_NUMBERS=[29,90]; REFERENCE=Ref.: 29 Comment A 90 day rat subchronic gavage study (ref; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 29 Comment A 90 day rat subchronic gavage study (ref","dose":"At terminal haematological examination there was a slight anaemia in male rats in the high dose group.","duration":"13 weeks","effect":"he diet for 13 weeks. At both levels of treatment the rats appeared healthy and there were no deaths. The growth rate was reduced at the highest level of DEGEE. At terminal haematological examination there was a slight anaemia in male rats in the high dose group. The relative kidney weight was significantly increased in the high dose group (14% male, 16% females). Histological examination showed hydropic degeneration of the proximal renal tubules. The males were more affected than the females. It is concluded that NOAEL is about 250 mg/kg bw/day. Ref.: 29 Comment A 90 day rat subchronic gavage study (ref.: 30) has been evaluated by the French authorities (this study has not been submitted to SCCS). The French authorities stated: “Among the studies submitted to the experts of AFSSAPS, a 90 day subchronic oral (gavage) toxicity study in rats with DEGEE at the unique dose of 180 mg/kg bw/d. Toxicological endpoints measured during the study included clinical observations, body weights, feed consumption, ophthalmology, clinical chem","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":25,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
=400 |
mg/kg bw/day |
rat |
oral |
90 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 400; DOSE=No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog:; EFFECT=g: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog:","duration":"90 day","effect":"g: Hydropic degeneration of the proximal renal tubules in one of two females. 167 mg/kg: No effects recorded NOAEL = 167 mg/kg bw/day 29 90 day Dog: Beagle m + f 2000/1500 mg/kg: Due to deaths, dose reduced to 1500 mg/kg. 1000 mg/kg: 11.7% (non-significant) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carr","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 400","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
=200 |
mg/kg bw/day |
rat |
oral |
2 year |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT== 200; DOSE=NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:; EFFECT=t) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:","duration":"2 year","effect":"t) and 22.7% (p= 0.01) in absolute and relative liver weight in females. Alkaline phosphatise significantly increased both among males and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 200","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
mg/kg bw/day |
rat |
oral |
2 year |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:; EFFECT=and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"NOAEL = 400 mg/kg bw/day N- 34 2 year Rat:","duration":"2 year","effect":"and females. 400 mg/kg: Urine sodium and chloride and urine creatinine significantly decreased among males but not among females. NOAEL = 400 mg/kg bw/day N- 34 2 year Rat: Albino m + f Two samples, one containing 29.5% and one less than 0.2% ethylene glycol. Results with the latter is given. 950 mg/kg: 7% with pathological kidney changes. 200 mg/kg: No pathological kidney changes. NOAEL = 200 mg/kg bw/day 34 The toxicity of DEGEE has been examined in oral repeated dose studies with mice, rats, pigs and dogs. A NOAEL of 850 – 1000 mg/kg bw/day was found in one study with mice based on increased relative kidney weight. Five studies have been carried out with rats. The observed NOAELs varied from 180 to 1340 mg/kg bw/day. The lowest value was based on a one dose study with no effect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
200 |
mg/kg bw/day |
rat |
oral |
90 day |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=200; DOSE=In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses.; EFFECT=ffect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. The concentration of ethylene glycol in this study was higher than accepted in cosmetic preparations and the study was not performed according to OECD guidelines and GLP. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS. However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according to modern guidelines and with high purity DEGEE (purity >99.9%). In this study, liver changes were observed at 1000 mg/kg bw/day. Based on the results of this study the SCCS considered the NOAEL for repeated dose toxicity to be 400 mg/kg bw/day. Inhalation In the 28 days st; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses.","duration":"90 day","effect":"ffect reported. In a two year and a 90 day rat study, NOAELs of 200 - 250 mg/kg bw/day was recorded based on pathological kidney changes at 5 to 10 times higher doses. In a 90 day pig study, kidney damage was observed at 500 mg/kg bw/day and a NOAEL of 167 mg/kg bw/day was derived. The concentration of ethylene glycol in this study was higher than accepted in cosmetic preparations and the study was not performed according to OECD guidelines and GLP. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS. However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according to modern guidelines and with high purity DEGEE (purity >99.9%). In this study, liver changes were observed at 1000 mg/kg bw/day. Based on the results of this study the SCCS considered the NOAEL for repeated dose toxicity to be 400 mg/kg bw/day. Inhalation In the 28 days st","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
400 |
mg/kg bw/day |
rat |
oral |
2 year |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=400; DOSE=In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS.; EFFECT=lines and GLP. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS. However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according to modern guidelines and with high purity DEGEE (purity >99.9%). In this study, liver changes were observed at 1000 mg/kg bw/day. Based on the results of this study the SCCS considered the NOAEL for repeated dose toxicity to be 400 mg/kg bw/day. Inhalation In the 28 days study rats were exposed to 90, 270 and 1100 mg/m3 DEGEE 6 h/day 5 days/week. Mild local irritation of the larynx and nasal turbinates were found in rats; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS.","duration":"2 year","effect":"lines and GLP. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day based on an albino 2 year oral study from 1964 was used in the calculation of MOS. However, a newly submitted 13 week dog study, in contrast to the previously available studies, was performed conforming to GLP and according to modern guidelines and with high purity DEGEE (purity >99.9%). In this study, liver changes were observed at 1000 mg/kg bw/day. Based on the results of this study the SCCS considered the NOAEL for repeated dose toxicity to be 400 mg/kg bw/day. Inhalation In the 28 days study rats were exposed to 90, 270 and 1100 mg/m3 DEGEE 6 h/day 5 days/week. Mild local irritation of the larynx and nasal turbinates were found in rats","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":29,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
1000 |
mg/kg bw/day |
rat |
oral |
- |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.; EFFECT=The total recovery was 100%. In the MOS calculation 64.2 μg/cm² (mean + 2SD) is used for the oxidative hair dye formulation and 17.5 μg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been determined. Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.","duration":"","effect":"The total recovery was 100%. In the MOS calculation 64.2 μg/cm² (mean + 2SD) is used for the oxidative hair dye formulation and 17.5 μg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been determined. Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP c","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":47,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_050"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
167 |
mg/kg bw/day |
rat |
oral |
13 week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=167; DOSE=Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.; EFFECT=+ 2SD) is used for the oxidative hair dye formulation and 17.5 μg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been determined. Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (S; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.","duration":"13 week","effect":"+ 2SD) is used for the oxidative hair dye formulation and 17.5 μg/cm² (mean + 2SD) for the non-oxidative formulation. The large difference in the dermal absorption reported in the three first study and the two second studies with hair dye formulations is noted. The cause for the large difference has not been determined. Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (S","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"167","page":47,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_051"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
400 |
mg/kg bw/day |
rat |
oral |
13 week |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=400; DOSE=Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.; EFFECT=e difference has not been determined. Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose on; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained.","duration":"13 week","effect":"e difference has not been determined. Repeated dose toxicity In five oral rat studies the NOAELs have varied from 180 to 1340 mg/kg bw/day while in a mice study a NOAEL of about 850 – 1000 mg/kg bw/day was obtained. In a pig study a NOAEL of 167 mg/kg bw/day based on the finding of hydropic degeneration of the proximal renal tubules in one of two female pigs (no effects in three male pigs) at the next higher dose (500 mg/kg bw/day) was found. None of these studies were performed according to guidelines or GLP. A NOAEL of 400 mg/kg bw/day for oral (gavage) administration of DEGEE (purity >99.9%) based on liver effects was found was found in a new well conducted guideline and GLP compliant 13 week study with dogs. In the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 200 mg/kg bw/day from an albino 2 year oral study from 1964 was used in the calculation of MOS. For the present opinion, the SCCS decided to use the 13 week dog study with a NOAEL of 400 mg/kg bw/day in the calculation of MOS. In a 28-day nose on","endpoint":"repeated dose toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":47,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_052"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw/d |
rat |
oral |
63 days |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=2000; DOSE=All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).; EFFECT=premating (63 days for males, 14 days for females) and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal t; CITATION=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; CITATION_NUMBERS=[43,300,1000,2000,6,17]; REFERENCE=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation","dose":"All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).","duration":"63 days","effect":"premating (63 days for males, 14 days for females) and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal t","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2000","page":21,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw/d |
rat |
oral |
20 days |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=2000; DOSE=All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).; EFFECT=) and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal toxicity in lower dose groups. Evidence of embryo-; CITATION=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; CITATION_NUMBERS=[43,300,1000,2000,6,17]; REFERENCE=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation","dose":"All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).","duration":"20 days","effect":") and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal toxicity in lower dose groups. Evidence of embryo-","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2000","page":21,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/d |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=was not a developmental toxicant. Ref.: 46 General comment DEGEE has low toxicity on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47; CITATION=Ref.: 46 General comment DEGEE has low toxicity on reproductive performance and development; CITATION_NUMBERS=[46]; REFERENCE=Ref.: 46 General comment DEGEE has low toxicity on reproductive performance and development; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 46 General comment DEGEE has low toxicity on reproductive performance and development","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"developmental","effect":"was not a developmental toxicant. Ref.: 46 General comment DEGEE has low toxicity on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":22,"route":"","species":"rat","study_id":"sccp_o_082_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg bw/d |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=ty on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47; CITATION=Ref.: 47; CITATION_NUMBERS=[47]; REFERENCE=Ref.: 47; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 47","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"","effect":"ty on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":22,"route":"","species":"rat","study_id":"sccp_o_082_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
167 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=167; DOSE=added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded.; EFFECT=added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to cause sensitisation. Reproductive toxi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded.","duration":"","effect":"added to the diet a NOAEL of 850 – 1000 mg/kg bw/d was concluded. In a similar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to cause sensitisation. Reproductive toxi","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"167","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
200 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=200; DOSE=0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded.; EFFECT=ar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded.","duration":"","effect":"ar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d based on kidney damage or bladder concretions in albino rats is used. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evi","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":24,"route":"oral","species":"rat","study_id":"sccp_o_082_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/d |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=demonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"","effect":"demonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity.","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":24,"route":"","species":"rat","study_id":"sccp_o_082_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg bw/d |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_082; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCP/1044/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=300; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=low toxicity on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"","effect":"low toxicity on reproductive performance and development. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity.","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":24,"route":"","species":"rat","study_id":"sccp_o_082_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw/d |
rat |
oral |
63 days |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=2000; DOSE=All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).; EFFECT=premating (63 days for males, 14 days for females) and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal t; CITATION=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; CITATION_NUMBERS=[43,300,1000,2000,6,17]; REFERENCE=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation","dose":"All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).","duration":"63 days","effect":"premating (63 days for males, 14 days for females) and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal t","endpoint":"reproductive toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2000","page":26,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw/d |
rat |
oral |
20 days |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=2000; DOSE=All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).; EFFECT=) and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal toxicity in lower dose groups. Evidence of embryo-; CITATION=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; CITATION_NUMBERS=[43,300,1000,2000,6,17]; REFERENCE=Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation","dose":"All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males).","duration":"20 days","effect":") and during mating. Dosing continued until gestation day 7 for females and until the day prior to necropsy for males (20 days after mating). All dose levels of Transcutol HP up to 2000 mg/kg bw/d were well tolerated in rat, although minor effects on clinical condition and body weight was observed at the higher dose levels (mainly in males). There were no effects of DEGEE on gonadal function, fertility and reproductive performance in any group. It was concluded that NOAEL for fertility was 2000 mg/kg bw/d and that NOAEL for general toxicity was 1000 mg/kg bw/d. Ref.: 43 Pregnant female rats received 0, 300, 1000, and 2000 mg/kg bw/d with Transcutol by gavage from day 6 to day 17 of gestation. The animals were killed at day 20 for maternal, foetal soft tissue and skeletal evaluations. The highest dose level of 2000 mg/kg bw/d of Transcutol HP resulted in slight maternal toxicity characterised by reduction in body weight gain and food consumption. There was no evidence of maternal toxicity in lower dose groups. Evidence of embryo-","endpoint":"reproductive toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2000","page":26,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/d |
rat |
- |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1000; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=t DEGEE was not a developmental toxicant. Ref.: 46 Comment DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47; CITATION=Ref.: 46 Comment DEGEE has low toxicity on reproductive performance and development; CITATION_NUMBERS=[46]; REFERENCE=Ref.: 46 Comment DEGEE has low toxicity on reproductive performance and development; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 46 Comment DEGEE has low toxicity on reproductive performance and development","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"developmental","effect":"t DEGEE was not a developmental toxicant. Ref.: 46 Comment DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47","endpoint":"reproductive toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":27,"route":"","species":"rat","study_id":"sccp_o_161_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg bw/d |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=300; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=y on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47; CITATION=Ref.: 47; CITATION_NUMBERS=[47]; REFERENCE=Ref.: 47; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 47","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"","effect":"y on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered to be the NOAEL for embryo-foetal toxicity. 3.3.9. Toxicokinetics An anecdotal report of rabbits treated orally or by s.c. injection indicated degradation of DEGEE and elimination in the urine as glucuronic conjugates. Ref.: 47","endpoint":"reproductive toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":27,"route":"","species":"rat","study_id":"sccp_o_161_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
200 |
mg/kg bw/d |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=200; DOSE=0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded.; EFFECT=ar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reprod; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded.","duration":"","effect":"ar study with white pigs and the following doses; 0, 167, 500, and 1500 mg/kg bw/d, NOAEL of 167 mg/kg bw/d was concluded. Histological examination showed hydropic degeneration of the proximal renal tubules at the highest level of treatment and at 500 mg/kg bw/d. A NOAEL can be calculated from several oral studies. In studies of rats the NOAEL varied from 180 to 800 mg/kg bw/day, in mice it was about 850 – 1000 kg/kg bw/d, while in pigs a NOAEL of 167 mg/kg bw/d was reported after gavage. In the MOS calculation a NOAEL of 200 mg/kg bw/d was found based on kidney damage or bladder concretions in a two year drinking water study with albino rats. DEGEE given orally to an adult human at a dose of about 20 mg/kg bw resulted in formation of 2-(2-ethoxyethoxy)acetic acid as a major (68% of the dose) metabolite in the urine. Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. It has not been demonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reprod","endpoint":"reproductive toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":30,"route":"oral","species":"rat","study_id":"sccp_o_161_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/d |
rat |
dermal |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=1000; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=emonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. Dermal absorption (for use in concentrations up to 1.5% in cosmetic products) Three well-conducted in vitro studies on percutaneous absorption through human skin are available. In a study of a shampoo formulation (rinse off) with a contact time of 30 min, 21.6 ± 10.6% was absorbed using a shampoo with 5% DEGEE (total recovery 91%). With 10% DEGEE 17.5 ± 3.9% was absorbed (total recovery 91%). In the second study wi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"","effect":"emonstrated to cause sensitisation. Reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. Dermal absorption (for use in concentrations up to 1.5% in cosmetic products) Three well-conducted in vitro studies on percutaneous absorption through human skin are available. In a study of a shampoo formulation (rinse off) with a contact time of 30 min, 21.6 ± 10.6% was absorbed using a shampoo with 5% DEGEE (total recovery 91%). With 10% DEGEE 17.5 ± 3.9% was absorbed (total recovery 91%). In the second study wi","endpoint":"reproductive toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":30,"route":"dermal","species":"rat","study_id":"sccp_o_161_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg bw/d |
rat |
dermal |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccp_o_161; REPORT_TITLE=OPINION ON Diethyleneglycol monoethylether; OPINION_NUMBER=SCCP/1200/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted 19 December 2006; VALUE_TEXT=300; DOSE=In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.; EFFECT=ow toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. Dermal absorption (for use in concentrations up to 1.5% in cosmetic products) Three well-conducted in vitro studies on percutaneous absorption through human skin are available. In a study of a shampoo formulation (rinse off) with a contact time of 30 min, 21.6 ± 10.6% was absorbed using a shampoo with 5% DEGEE (total recovery 91%). With 10% DEGEE 17.5 ± 3.9% was absorbed (total recovery 91%). In the second study with a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity.","duration":"","effect":"ow toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential, but suggested a selective effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/d was considered a NOAEL for maternal toxicity. The dose of 300 mg/kg bw/d was considered NOAEL for embryo-foetal toxicity. Dermal absorption (for use in concentrations up to 1.5% in cosmetic products) Three well-conducted in vitro studies on percutaneous absorption through human skin are available. In a study of a shampoo formulation (rinse off) with a contact time of 30 min, 21.6 ± 10.6% was absorbed using a shampoo with 5% DEGEE (total recovery 91%). With 10% DEGEE 17.5 ± 3.9% was absorbed (total recovery 91%). In the second study with a","endpoint":"reproductive toxicity","ingredient":"DEGEE is used in cosmetic","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":30,"route":"dermal","species":"rat","study_id":"sccp_o_161_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/day |
rat |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=1000; DOSE=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 35 additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity.; EFFECT=SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 35 additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 females per group Test substance: Transcutol HP (purity: 99.9%) Batch No: 0025005 Dose level: 0, 300, 1000, 2000 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 35 additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity.","duration":"","effect":"SCCS/1316/10 Opinion on diethylene glycol monoethyl ether (DEGEE) ___________________________________________________________________________________________ 35 additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryo-foetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 females per group Test substance: Transcutol HP (purity: 99.9%) Batch No: 0025005 Dose level: 0, 300, 1000, 2000 mg/kg bw","endpoint":"reproductive toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":35,"route":"","species":"rat","study_id":"sccs_o_039_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
oral |
10 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=2000; DOSE=The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in...; EFFECT=The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD r; CITATION=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; CITATION_NUMBERS=[23,13,17,7927,96]; REFERENCE=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0","dose":"The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in...","duration":"10 days","effect":"The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD r","endpoint":"reproductive toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":36,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
dermal |
10 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=2000; DOSE=nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).; EFFECT=nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD rats to investigate its potential for developmental toxicity. Four doses each 2.5 hours; CITATION=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; CITATION_NUMBERS=[23,13,17,7927,96]; REFERENCE=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0","dose":"nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).","duration":"10 days","effect":"nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD rats to investigate its potential for developmental toxicity. Four doses each 2.5 hours","endpoint":"reproductive toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":36,"route":"dermal","species":"rat","study_id":"sccs_o_039_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
oral |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=2000; DOSE=The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).; EFFECT=be considered as additional information due to methodological limitations. The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings wh; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).","duration":"prenatal","effect":"be considered as additional information due to methodological limitations. The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings wh","endpoint":"reproductive toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":46,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_046"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
oral |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=2000; DOSE=dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).; EFFECT=dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of crani; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).","duration":"prenatal","effect":"dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of crani","endpoint":"reproductive toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":46,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_047"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
29190 |
- |
rat |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_039; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1316/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 19 December 2006; VALUE_TEXT=unclear:r (Carbitol), J. Ind. Hyg. Toxicol. 29,190-195 42. Helton DR, Osborne DW, Pierson SK, Buonarati MH, Bethem RA (2000) Pharmacokinetic profiles in rats after intravenous, oral, or dermal administration of dapsone, Drug Metabolism Disposition, 28, 925-929 43. Levi-Schaffer F, Dayan N, Touitou E (1996) Diethylene glycol monoethyl ether (Transcutol) displays antiproliferative properties alone and in combination with xanthines, Skin Pharmacology, 9, 53-59 44. Masson P (2003) personal assessment for Gattefosse concerning NOAEL of the segment II study with Trancutol 45. Natl. Toxicol. Program, U.S. National Toxicology Program acute toxicity studies for Diethylene glycol monoethyl ether [on line] (http://www.pesticideinfo.org/List_NTPStudies.jsp?Rec_Id=PC35499) 46. Nazarali A, Puthucode R (1998) In vivo animal models of teratogenicity, 253-293, in: Neuromethods, 32 (Eds. Boulton AA, Baker GB, Bateson AN) Humana Press 47. NTP: Abstract for Repro Tox: Diethylene glycol monoethyl ether, Reproduction and fertility assessment in CD-1 mice when; EFFECT=r (Carbitol), J. Ind. Hyg. Toxicol. 29,190-195 42. Helton DR, Osborne DW, Pierson SK, Buonarati MH, Bethem RA (2000) Pharmacokinetic profiles in rats after intravenous, oral, or dermal administration of dapsone, Drug Metabolism Disposition, 28, 925-929 43. Levi-Schaffer F, Dayan N, Touitou E (1996) Diethylene glycol monoethyl ether (Transcutol) displays antiproliferative properties alone and in combination with xanthines, Skin Pharmacology, 9, 53-59 44. Masson P (2003) personal assessment for Gattefosse concerning NOAEL of the segment II study with Trancutol 45. Natl. Toxicol. Program, U.S. National Toxicology Program acute toxicity studies for Diethylene glycol monoethyl ether [on line] (http://www.pesticideinfo.org/List_NTPStudies.jsp?Rec_Id=PC35499) 46. Nazarali A, Puthucode R (1998) In vivo animal models of teratogenicity, 253-293, in: Neuromethods, 32 (Eds. Boulton AA, Baker GB, Bateson AN) Humana Press 47. NTP: Abstract for Repro Tox: Diethylene glycol monoethyl ether, Reproduction and fertility assessment in CD-1 mice when; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"","duration":"","effect":"r (Carbitol), J. Ind. Hyg. Toxicol. 29,190-195 42. Helton DR, Osborne DW, Pierson SK, Buonarati MH, Bethem RA (2000) Pharmacokinetic profiles in rats after intravenous, oral, or dermal administration of dapsone, Drug Metabolism Disposition, 28, 925-929 43. Levi-Schaffer F, Dayan N, Touitou E (1996) Diethylene glycol monoethyl ether (Transcutol) displays antiproliferative properties alone and in combination with xanthines, Skin Pharmacology, 9, 53-59 44. Masson P (2003) personal assessment for Gattefosse concerning NOAEL of the segment II study with Trancutol 45. Natl. Toxicol. Program, U.S. National Toxicology Program acute toxicity studies for Diethylene glycol monoethyl ether [on line] (http://www.pesticideinfo.org/List_NTPStudies.jsp?Rec_Id=PC35499) 46. Nazarali A, Puthucode R (1998) In vivo animal models of teratogenicity, 253-293, in: Neuromethods, 32 (Eds. Boulton AA, Baker GB, Bateson AN) Humana Press 47. NTP: Abstract for Repro Tox: Diethylene glycol monoethyl ether, Reproduction and fertility assessment in CD-1 mice when","endpoint":"reproductive toxicity","ingredient":"could be considered safe for the","loael_value":"","noael_unit":"","noael_value":"unclear:r (Carbitol), J. Ind. Hyg. Toxicol. 29,190-195 42. Helton DR, Osborne DW, Pierson SK, Buonarati MH, Bethem RA (2000) Pharmacokinetic profiles in rats after intravenous, oral, or dermal administration of dapsone, Drug Metabolism Disposition, 28, 925-929 43. Levi-Schaffer F, Dayan N, Touitou E (1996) Diethylene glycol monoethyl ether (Transcutol) displays antiproliferative properties alone and in combination with xanthines, Skin Pharmacology, 9, 53-59 44. Masson P (2003) personal assessment for Gattefosse concerning NOAEL of the segment II study with Trancutol 45. Natl. Toxicol. Program, U.S. National Toxicology Program acute toxicity studies for Diethylene glycol monoethyl ether [on line] (http://www.pesticideinfo.org/List_NTPStudies.jsp?Rec_Id=PC35499) 46. Nazarali A, Puthucode R (1998) In vivo animal models of teratogenicity, 253-293, in: Neuromethods, 32 (Eds. Boulton AA, Baker GB, Bateson AN) Humana Press 47. NTP: Abstract for Repro Tox: Diethylene glycol monoethyl ether, Reproduction and fertility assessment in CD-1 mice when","page":52,"route":"oral","species":"rat","study_id":"sccs_o_039_noael_051"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2200 |
mg/kg bw/d |
rat |
- |
10 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=2200; DOSE=The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group.; EFFECT=had only minimal effects on fertility or reproductive performance. Offspring assessment. The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group. A significant decrease (34%) in motile sperm from de cauda epididymis in males exposed to 2.5% DEGEE was seen. In addition the relative liver weights were increased (16% in males and 10% in females). Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in sperm motility in F1 males at 4400 mg/kg bw/d. Increased liver weight was also seen at this dose. Rats Prenatal developmental toxicity study in rats Guideline: Comparable to OECD 414 Species/strain: Rat/Sprague-Dawley Group size: 25 pregnant females per group Test substance: Transcutol HP (purity: 99.98%) Batch: D 4089 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehicle: St; CITATION=Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in s; CITATION_NUMBERS=[41,42,2200,1]; REFERENCE=Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in s; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in s","dose":"The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group.","duration":"10 days","effect":"had only minimal effects on fertility or reproductive performance. Offspring assessment. The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group. A significant decrease (34%) in motile sperm from de cauda epididymis in males exposed to 2.5% DEGEE was seen. In addition the relative liver weights were increased (16% in males and 10% in females). Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in sperm motility in F1 males at 4400 mg/kg bw/d. Increased liver weight was also seen at this dose. Rats Prenatal developmental toxicity study in rats Guideline: Comparable to OECD 414 Species/strain: Rat/Sprague-Dawley Group size: 25 pregnant females per group Test substance: Transcutol HP (purity: 99.98%) Batch: D 4089 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehicle: St","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2200","page":33,"route":"","species":"rat","study_id":"sccs_o_119_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2200 |
mg/kg bw/d |
rat |
- |
10 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=2200; DOSE=The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group.; EFFECT=performance. Offspring assessment. The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group. A significant decrease (34%) in motile sperm from de cauda epididymis in males exposed to 2.5% DEGEE was seen. In addition the relative liver weights were increased (16% in males and 10% in females). Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in sperm motility in F1 males at 4400 mg/kg bw/d. Increased liver weight was also seen at this dose. Rats Prenatal developmental toxicity study in rats Guideline: Comparable to OECD 414 Species/strain: Rat/Sprague-Dawley Group size: 25 pregnant females per group Test substance: Transcutol HP (purity: 99.98%) Batch: D 4089 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehicle: Sterile water; CITATION=Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in s; CITATION_NUMBERS=[41,42,2200,1]; REFERENCE=Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in s; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in s","dose":"The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group.","duration":"10 days","effect":"performance. Offspring assessment. The F1 generation from the final litters was reared and continuously treated with 0 or 2.5% DEGEE (4400 mg/kg bw/day) and at 74+10 days of age paired with nonsiblings from the same dose group. A significant decrease (34%) in motile sperm from de cauda epididymis in males exposed to 2.5% DEGEE was seen. In addition the relative liver weights were increased (16% in males and 10% in females). Ref.: 41, 42 Comment SCCS consider NOAEL for parental systemic toxicity 2200 mg/kg bw/d, NOAEL for F1 reproduction 2200 mg/kg bw/d, There was no effect on fertility despite decrease in sperm motility in F1 males at 4400 mg/kg bw/d. Increased liver weight was also seen at this dose. Rats Prenatal developmental toxicity study in rats Guideline: Comparable to OECD 414 Species/strain: Rat/Sprague-Dawley Group size: 25 pregnant females per group Test substance: Transcutol HP (purity: 99.98%) Batch: D 4089 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehicle: Sterile water","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2200","page":33,"route":"","species":"rat","study_id":"sccs_o_119_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
>2000 |
mg/kg bw |
- |
- |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=>2000; DOSE=There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.; EFFECT=ether ___________________________________________________________________________________________ 35 development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.","duration":"prenatal","effect":"ether ___________________________________________________________________________________________ 35 development. There was also some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":">2000","page":35,"route":"","species":"","study_id":"sccs_o_119_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
300 |
mg/kg bw/day |
rat |
- |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=300; DOSE=some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.; EFFECT=some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 fe; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related.","duration":"prenatal","effect":"some variation in the spontaneous increased incidence of delayed ossification in some cranial bones at 1000 mg/kg bw but these were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 fe","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":35,"route":"","species":"rat","study_id":"sccs_o_119_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/day |
rat |
- |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=hese were partly not dose-related.; EFFECT=hese were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 females per group Test substance: Transcutol HP (purity: 99.9%) Batch: 0025005 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehic; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"hese were partly not dose-related.","duration":"prenatal","effect":"hese were partly not dose-related. The authors concluded that the NOAEL for maternal toxicity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 females per group Test substance: Transcutol HP (purity: 99.9%) Batch: 0025005 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehic","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":35,"route":"","species":"rat","study_id":"sccs_o_119_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/day |
rat |
- |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=ity as well as for prenatal developmental toxicity was 1000 mg/kg bw.; EFFECT=ity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 females per group Test substance: Transcutol HP (purity: 99.9%) Batch: 0025005 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehicle: Sterile water Application volume: 2 or 4 ml/kg bw (0 and 2000 mg/kg bw or 300 and 1000; CITATION=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; CITATION_NUMBERS=[26,1044,6,1200,8,300]; REFERENCE=Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity","dose":"ity as well as for prenatal developmental toxicity was 1000 mg/kg bw.","duration":"prenatal","effect":"ity as well as for prenatal developmental toxicity was 1000 mg/kg bw. There was no indication of teratogenicity up to the highest dose level tested and therefore the respective NOAEL was >2000 mg/kg bw. N Ref.: 26 Comment The SCCS concluded in the previous opinions on DEGEE (SCCP/1044/06, SCCP/1200/08) a NOAEL of 300 mg/kg bw/day for embryo-foetal toxicity. However, in the recent submission, additional argumentation for the NOAEL of 1000 mg/kg bw/day was provided and the SCCS considers 1000 mg/kg bw/day being the NOAEL for maternal and embryofetal toxicity. It was concluded that there was no indication of teratogenicity at any dose level used in the study. Fertility and general reproductive performance in rats Guideline: Elements comparable to OECD 415 Species/strain: Rat/Sprague-Dawley Group size: 24 males and 24 females per group Test substance: Transcutol HP (purity: 99.9%) Batch: 0025005 Dose level: 0, 300, 1000, 2000 mg/kg bw Vehicle: Sterile water Application volume: 2 or 4 ml/kg bw (0 and 2000 mg/kg bw or 300 and 1000","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":35,"route":"","species":"rat","study_id":"sccs_o_119_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
oral |
10 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=2000; DOSE=The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in...; EFFECT=The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD r; CITATION=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; CITATION_NUMBERS=[23,13,17,7927,96]; REFERENCE=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0","dose":"The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in...","duration":"10 days","effect":"The authors concluded that the oral administration of Transcutol within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD r","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":36,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
dermal |
10 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=2000; DOSE=nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).; EFFECT=nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD rats to investigate its potential for developmental toxicity. Four doses each 2.5 hours; CITATION=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; CITATION_NUMBERS=[23,13,17,7927,96]; REFERENCE=Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0","dose":"nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).","duration":"10 days","effect":"nd general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article or gonadal function, fertility and reproductive performance in any group. Finally, the no observed adverse effects level (NOAEL) for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw in male and female Sprague-Dawley rats under the condition of this study. N Ref.: 23 Dermal route Rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 13 rats, control 17 rats Test substance: DEGEE Batch: Lot 792796 Purity: / Dose levels: 0.35 ml x 4 per day from GD 7 – 16 Route: Skin Exposures: 10 days GLP: / DEGEE was applied to the skin (unoccluded) of 13 pregnant SD rats to investigate its potential for developmental toxicity. Four doses each 2.5 hours","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":36,"route":"dermal","species":"rat","study_id":"sccs_o_119_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
102 |
ppm |
- |
- |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=102; DOSE=in control and 0.9 in treated) live foetuses (174 in control and 250 in treated), live foetuses/litter (11.6 in control and 12,5 in treated), live foetal weight, or the number of litters with abnormal foetuses (5[33%] in control and 6[30%] in treated).; EFFECT=SCCS-rejected applicant NOAEL: in control and 0.9 in treated) live foetuses (174 in control and 250 in treated), live foetuses/litter (11.6 in control and 12,5 in treated), live foetal weight, or the number of litters with abnormal foetuses (5[33%] in control and 6[30%] in treated). There was no statistical significant effect of treatment on the number of foetuses with visceral or skeletal malformations or on the specific types of malformations or variations noted. Ref.: 46 Comment The SCCS considers, on the basis of the above experiment, the NOAEL of maternal toxicity and teratogenicity to be 102 ppm (570 mg/m3; 11.4 mg/kg bw/d) based on no effects at the only dose tested. General conclusion on reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential and was; CITATION=Ref.: 46 Comment The SCCS considers, on the basis of the above experiment, the NOAEL of maternal toxicity and teratogenicity to be 102 ppm (570 mg/m3; CITATION_NUMBERS=[46,102,570,3]; REFERENCE=Ref.: 46 Comment The SCCS considers, on the basis of the above experiment, the NOAEL of maternal toxicity and teratogenicity to be 102 ppm (570 mg/m3; DETAILS_JSON={"cas_number":"111-90-0","citation":"Ref.: 46 Comment The SCCS considers, on the basis of the above experiment, the NOAEL of maternal toxicity and teratogenicity to be 102 ppm (570 mg/m3","dose":"in control and 0.9 in treated) live foetuses (174 in control and 250 in treated), live foetuses/litter (11.6 in control and 12,5 in treated), live foetal weight, or the number of litters with abnormal foetuses (5[33%] in control and 6[30%] in treated).","duration":"","effect":"SCCS-rejected applicant NOAEL: in control and 0.9 in treated) live foetuses (174 in control and 250 in treated), live foetuses/litter (11.6 in control and 12,5 in treated), live foetal weight, or the number of litters with abnormal foetuses (5[33%] in control and 6[30%] in treated). There was no statistical significant effect of treatment on the number of foetuses with visceral or skeletal malformations or on the specific types of malformations or variations noted. Ref.: 46 Comment The SCCS considers, on the basis of the above experiment, the NOAEL of maternal toxicity and teratogenicity to be 102 ppm (570 mg/m3; 11.4 mg/kg bw/d) based on no effects at the only dose tested. General conclusion on reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential and was","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"ppm","noael_value":"102","page":37,"route":"","species":"","study_id":"sccs_o_119_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
1000 |
mg/kg bw/day |
rat |
inhalation |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=1000; DOSE=In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryofetal toxicity.; EFFECT=sted. General conclusion on reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential and was not considered an adverse effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryofetal toxicity. In an inhalation study no effects were found at the single dose studied (102 ppm; 11.4 mg/kg bw/d). 3.3.9. Toxicokinetics 3.3.9.1 In vitro metabolism; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryofetal toxicity.","duration":"","effect":"sted. General conclusion on reproductive toxicity DEGEE has low toxicity on reproductive performance and development. Evidence of embryo- foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of cranial bones. These minor skeleton findings were not considered to be indicative of a teratogenic potential and was not considered an adverse effect on the developing foetuses. In a rat study the dose of 1000 mg/kg bw/day was considered a NOAEL for maternal and embryofetal toxicity. In an inhalation study no effects were found at the single dose studied (102 ppm; 11.4 mg/kg bw/d). 3.3.9. Toxicokinetics 3.3.9.1 In vitro metabolism","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":37,"route":"inhalation","species":"rat","study_id":"sccs_o_119_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
oral |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=2000; DOSE=The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).; EFFECT=be considered as additional information due to methodological limitations. The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings wh; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).","duration":"prenatal","effect":"be considered as additional information due to methodological limitations. The oral administration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings wh","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":48,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_056"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2000 |
mg/kg bw |
rat |
oral |
prenatal |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_119; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOETHYL ETHER (DEGEE); OPINION_NUMBER=SCCS/1507/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2013; VALUE_TEXT=2000; DOSE=dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).; EFFECT=dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of crani; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-90-0","citation":"","dose":"dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males).","duration":"prenatal","effect":"dministration of DEGEE within the fertility and general reproductive performance study in female Sprague-Dawley rats, showed that all doses levels, up to 2000 mg/kg bw/day, were well tolerated, although minor effects on clinical condition and body weight were observed at the higher dose levels (mainly in males). There were no effects of the test article on gonadal function, fertility and reproductive performance in any group. The NOAEL for fertility and general reproductive performance was 2000 mg/kg bw, while the NOAEL for systemic toxicity was 1000 mg/kg bw. In the prenatal developmental toxicity study, the oral administration of DEGEE to pregnant Sprague-Dawley rats from implantation to day 17 of gestation resulted in maternal toxicity at 2000 mg/kg bw in form of retarded body weight gain and reduced food consumption. Gestation was not affected at any dose level. Evidence of embryo-foetal toxicity was restricted to minor skeletal findings which principally included an increase in the incidence of reduced ossification of crani","endpoint":"reproductive toxicity","ingredient":"DEGEE as solvent in an on-head concentration up","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":48,"route":"oral","species":"rat","study_id":"sccs_o_119_noael_057"} |