| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
10000 |
ppm |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=10,000; DOSE=Conclusion Treatment with 2-phenoxyethanol at concentrations of 500, 2,500 and 10,000 ppm in the diet showed no evidence of treatment-related adverse effects.; EFFECT=ing to any treatment-related effect in these organs, these differences relative to the controls were considered not to be indicative of organ-related toxicity. There was no evidence of treatment-related effects on histopathology in any of the tissues evaluated. There were no treatment-related ophthalmological findings. Conclusion Treatment with 2-phenoxyethanol at concentrations of 500, 2,500 and 10,000 ppm in the diet showed no evidence of treatment-related adverse effects. The no-observed-adverse- effect level (NOAEL) for 2-phenoxyethanol was therefore concluded to be 10,000 ppm in diet corresponding to an intake of 697 mg/kg bw/day in males and 939 mg/kg bw/day in females. Ref.: 10 SCCS comment The SCCS noted that in both the control groups and in all treatment groups, parameters of food intake, water intake and body weight gain declined during the study and persisted during the recovery period. These unusual data are not commented upon and not explained. It is assumed that the animals of this study were ill, potentially due; CITATION=Ref.: 10 SCCS comment The SCCS noted that in both the control groups and in all treatment groups, parameters of food intake, water intake and body weight gain declined during the study a; CITATION_NUMBERS=[10]; REFERENCE=Ref.: 10 SCCS comment The SCCS noted that in both the control groups and in all treatment groups, parameters of food intake, water intake and body weight gain declined during the study a; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 10 SCCS comment The SCCS noted that in both the control groups and in all treatment groups, parameters of food intake, water intake and body weight gain declined during the study a","dose":"Conclusion Treatment with 2-phenoxyethanol at concentrations of 500, 2,500 and 10,000 ppm in the diet showed no evidence of treatment-related adverse effects.","duration":"","effect":"ing to any treatment-related effect in these organs, these differences relative to the controls were considered not to be indicative of organ-related toxicity. There was no evidence of treatment-related effects on histopathology in any of the tissues evaluated. There were no treatment-related ophthalmological findings. Conclusion Treatment with 2-phenoxyethanol at concentrations of 500, 2,500 and 10,000 ppm in the diet showed no evidence of treatment-related adverse effects. The no-observed-adverse- effect level (NOAEL) for 2-phenoxyethanol was therefore concluded to be 10,000 ppm in diet corresponding to an intake of 697 mg/kg bw/day in males and 939 mg/kg bw/day in females. Ref.: 10 SCCS comment The SCCS noted that in both the control groups and in all treatment groups, parameters of food intake, water intake and body weight gain declined during the study and persisted during the recovery period. These unusual data are not commented upon and not explained. It is assumed that the animals of this study were ill, potentially due","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"10,000","page":20,"route":"oral","species":"","study_id":"sccs_o_195_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.5 |
% |
rat |
oral |
4 weeks |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=0.50; DOSE=Summary report produced in 1993 (see further information below) In the study summary report of 1993, a dose range-finding study (4 weeks treatment) was mentioned with dosing of 0.00%, 0.05%, 0.10%, 0.20% and 0.50% of the test substance in the diet corresponding to about 0, 50, 100, 200 and 500 mg/kg bw/day.; EFFECT=e further information below) In Life Period: 17 Aug 1987 – 21 Dec 1987 Report Date: Summary report produced in 1993 (see further information below) In the study summary report of 1993, a dose range-finding study (4 weeks treatment) was mentioned with dosing of 0.00%, 0.05%, 0.10%, 0.20% and 0.50% of the test substance in the diet corresponding to about 0, 50, 100, 200 and 500 mg/kg bw/day. Some minor effects were observed at the highest dose, which were not considered adverse (no details described). Therefore, a NOAEL at the dietary level of 0.50% corresponding to 550 mg/kg bw/day was concluded. Groups of 15 male and 15 female Colworth Wistar rats were fed 2-phenoxyethanol in the diet at levels of 0.05, 0.1, 0.2 or 0.5% for a period of 13 weeks. A similarly constituted control group received the untreated diet for the same period. An additional 5 male and 5 female recovery group rats were included in the control and high dose groups, and after the 13-week treatment period were maintained on the untreated control diet for a fur; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Summary report produced in 1993 (see further information below) In the study summary report of 1993, a dose range-finding study (4 weeks treatment) was mentioned with dosing of 0.00%, 0.05%, 0.10%, 0.20% and 0.50% of the test substance in the diet corresponding to about 0, 50, 100, 200 and 500 mg/kg bw/day.","duration":"4 weeks","effect":"e further information below) In Life Period: 17 Aug 1987 – 21 Dec 1987 Report Date: Summary report produced in 1993 (see further information below) In the study summary report of 1993, a dose range-finding study (4 weeks treatment) was mentioned with dosing of 0.00%, 0.05%, 0.10%, 0.20% and 0.50% of the test substance in the diet corresponding to about 0, 50, 100, 200 and 500 mg/kg bw/day. Some minor effects were observed at the highest dose, which were not considered adverse (no details described). Therefore, a NOAEL at the dietary level of 0.50% corresponding to 550 mg/kg bw/day was concluded. Groups of 15 male and 15 female Colworth Wistar rats were fed 2-phenoxyethanol in the diet at levels of 0.05, 0.1, 0.2 or 0.5% for a period of 13 weeks. A similarly constituted control group received the untreated diet for the same period. An additional 5 male and 5 female recovery group rats were included in the control and high dose groups, and after the 13-week treatment period were maintained on the untreated control diet for a fur","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"0.50","page":21,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.2 |
% |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=0.2; DOSE=Conclusion The study director set the no-observed-effect level (NOEL) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day.; EFFECT=0.5% at the end of the treatment period but not after the recovery period. There were no macroscopic changes that were considered treatment-related. The only histopathological change related to treatment was a reduced level of total parenchymal lipid deposition in male rats at 0.5% (observed following Oil red O staining). This was not apparent at the recovery sacrifice. The study authors judged that this change was not of toxicological significance. Conclusion The study director set the no-observed-effect level (NOEL) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day. The main findings at the 0.5% level were judged by the study director to be the reversible lower food utilisation efficiency in males, the reversible higher water consumption in females, the reduced plasma total cholesterol which was still present in males during week 18, the reversible serum total protein in males, and the reduced platelets which were still lower than control during week 18. The summary report does not define a n; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Conclusion The study director set the no-observed-effect level (NOEL) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day.","duration":"","effect":"0.5% at the end of the treatment period but not after the recovery period. There were no macroscopic changes that were considered treatment-related. The only histopathological change related to treatment was a reduced level of total parenchymal lipid deposition in male rats at 0.5% (observed following Oil red O staining). This was not apparent at the recovery sacrifice. The study authors judged that this change was not of toxicological significance. Conclusion The study director set the no-observed-effect level (NOEL) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day. The main findings at the 0.5% level were judged by the study director to be the reversible lower food utilisation efficiency in males, the reversible higher water consumption in females, the reduced plasma total cholesterol which was still present in males during week 18, the reversible serum total protein in males, and the reduced platelets which were still lower than control during week 18. The summary report does not define a n","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"0.2","page":22,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.5 |
% |
- |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=0.5; DOSE=L) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day.; EFFECT=L) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day. The main findings at the 0.5% level were judged by the study director to be the reversible lower food utilisation efficiency in males, the reversible higher water consumption in females, the reduced plasma total cholesterol which was still present in males during week 18, the reversible serum total protein in males, and the reduced platelets which were still lower than control during week 18. The summary report does not define a no-observed-adverse-effect level (NOAEL). Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-based inspections at key points during the study. On completion of the study, a protocol amendment was produced to state that only a non-GLP summary report would be produced. Therefore, no claim of GLP compliance can be made for the study report. On completion of the study, all raw data and records were retained indefinitel; CITATION=Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-ba; CITATION_NUMBERS=[11]; REFERENCE=Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-ba; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-ba","dose":"L) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day.","duration":"","effect":"L) at the dietary level of 0.2%, which corresponded to a mean intake of 164 mg/kg/day. The main findings at the 0.5% level were judged by the study director to be the reversible lower food utilisation efficiency in males, the reversible higher water consumption in females, the reduced plasma total cholesterol which was still present in males during week 18, the reversible serum total protein in males, and the reduced platelets which were still lower than control during week 18. The summary report does not define a no-observed-adverse-effect level (NOAEL). Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-based inspections at key points during the study. On completion of the study, a protocol amendment was produced to state that only a non-GLP summary report would be produced. Therefore, no claim of GLP compliance can be made for the study report. On completion of the study, all raw data and records were retained indefinitel","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"0.5","page":22,"route":"oral","species":"","study_id":"sccs_o_195_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
0.5 |
% |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=0.5; DOSE=hich corresponded to a mean intake of 164 mg/kg/day.; EFFECT=hich corresponded to a mean intake of 164 mg/kg/day. The main findings at the 0.5% level were judged by the study director to be the reversible lower food utilisation efficiency in males, the reversible higher water consumption in females, the reduced plasma total cholesterol which was still present in males during week 18, the reversible serum total protein in males, and the reduced platelets which were still lower than control during week 18. The summary report does not define a no-observed-adverse-effect level (NOAEL). Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-based inspections at key points during the study. On completion of the study, a protocol amendment was produced to state that only a non-GLP summary report would be produced. Therefore, no claim of GLP compliance can be made for the study report. On completion of the study, all raw data and records were retained indefinitely. The; CITATION=Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-ba; CITATION_NUMBERS=[11]; REFERENCE=Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-ba; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-ba","dose":"hich corresponded to a mean intake of 164 mg/kg/day.","duration":"","effect":"hich corresponded to a mean intake of 164 mg/kg/day. The main findings at the 0.5% level were judged by the study director to be the reversible lower food utilisation efficiency in males, the reversible higher water consumption in females, the reduced plasma total cholesterol which was still present in males during week 18, the reversible serum total protein in males, and the reduced platelets which were still lower than control during week 18. The summary report does not define a no-observed-adverse-effect level (NOAEL). Ref: 11 Comments of the Applicant on Study Reliability The in-life portion of this study was conducted in accordance with GLP, which included an audit of the study protocol and study-based inspections at key points during the study. On completion of the study, a protocol amendment was produced to state that only a non-GLP summary report would be produced. Therefore, no claim of GLP compliance can be made for the study report. On completion of the study, all raw data and records were retained indefinitely. The","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"0.5","page":22,"route":"","species":"","study_id":"sccs_o_195_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
80 |
mg/kg bw/day |
rat |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=80; DOSE=ecreased erythrocyte number, decreased packed cell volume and decreased haemoglobin concentration, and kidney inflammation with epithelial cells and polymorphonuclear leukocytes in the urinary sediment) at 2000 mg/kg bw/day.; EFFECT=ecreased erythrocyte number, decreased packed cell volume and decreased haemoglobin concentration, and kidney inflammation with epithelial cells and polymorphonuclear leukocytes in the urinary sediment) at 2000 mg/kg bw/day. Liver, kidney and thyroid weights were increased at 2000 mg/kg bw/day. Inflammation of the kidneys was also seen in males at 400 mg/kg bw/day. Minor testicular changes were noted in a few high-dose male rats, but these changes were considered to be of equivocal toxicological significance. The NOEL in this study was reported as 80 mg/kg bw/day based on the finding of inflammation in the kidney in males at 400 mg/kg bw/day. Ref.: 40 SCCS comment Deaths of five animals during treatment for unknown reasons and probably not treatment- related suggest poor husbandry or animal treatment in the test facility. The purity of the 2- phenoxyethanol batch used in this study is unknown. The study is considered unreliable.; CITATION=Ref.: 40 SCCS comment Deaths of five animals during treatment for unknown reasons and probably not treatment- related suggest poor husbandry or animal treatment in the test facility; CITATION_NUMBERS=[40]; REFERENCE=Ref.: 40 SCCS comment Deaths of five animals during treatment for unknown reasons and probably not treatment- related suggest poor husbandry or animal treatment in the test facility; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 40 SCCS comment Deaths of five animals during treatment for unknown reasons and probably not treatment- related suggest poor husbandry or animal treatment in the test facility","dose":"ecreased erythrocyte number, decreased packed cell volume and decreased haemoglobin concentration, and kidney inflammation with epithelial cells and polymorphonuclear leukocytes in the urinary sediment) at 2000 mg/kg bw/day.","duration":"","effect":"ecreased erythrocyte number, decreased packed cell volume and decreased haemoglobin concentration, and kidney inflammation with epithelial cells and polymorphonuclear leukocytes in the urinary sediment) at 2000 mg/kg bw/day. Liver, kidney and thyroid weights were increased at 2000 mg/kg bw/day. Inflammation of the kidneys was also seen in males at 400 mg/kg bw/day. Minor testicular changes were noted in a few high-dose male rats, but these changes were considered to be of equivocal toxicological significance. The NOEL in this study was reported as 80 mg/kg bw/day based on the finding of inflammation in the kidney in males at 400 mg/kg bw/day. Ref.: 40 SCCS comment Deaths of five animals during treatment for unknown reasons and probably not treatment- related suggest poor husbandry or animal treatment in the test facility. The purity of the 2- phenoxyethanol batch used in this study is unknown. The study is considered unreliable.","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":23,"route":"","species":"rat","study_id":"sccs_o_195_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
10000 |
ppm |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=10,000; DOSE=ional epithelial hyperplasia was observed at 10,000 ppm in females (n=2 of 10 animals) and at 20,000 ppm in females (n=7 of 10 animals).; EFFECT=ional epithelial hyperplasia was observed at 10,000 ppm in females (n=2 of 10 animals) and at 20,000 ppm in females (n=7 of 10 animals). Slight urinary bladder transitional epithelial hyperplasia was observed in one male at 20,000 ppm. As mentioned above, urea nitrogen was increased in both sexes at 20,000 ppm and at 10,000 ppm in females. These observations are all considered treatment-related toxicologically significant effects. Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm. The decrease in platelets at 5000 ppm was not considered relevant for the establishment of the NOAEL due to the minimal degree of the effect and the absence of any functional impact on coagulation at any dose. Based on the overall weight of the evidence, the NOAEL is considered to be 5000 ppm corresponding; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"ional epithelial hyperplasia was observed at 10,000 ppm in females (n=2 of 10 animals) and at 20,000 ppm in females (n=7 of 10 animals).","duration":"","effect":"ional epithelial hyperplasia was observed at 10,000 ppm in females (n=2 of 10 animals) and at 20,000 ppm in females (n=7 of 10 animals). Slight urinary bladder transitional epithelial hyperplasia was observed in one male at 20,000 ppm. As mentioned above, urea nitrogen was increased in both sexes at 20,000 ppm and at 10,000 ppm in females. These observations are all considered treatment-related toxicologically significant effects. Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm. The decrease in platelets at 5000 ppm was not considered relevant for the establishment of the NOAEL due to the minimal degree of the effect and the absence of any functional impact on coagulation at any dose. Based on the overall weight of the evidence, the NOAEL is considered to be 5000 ppm corresponding","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"10,000","page":25,"route":"","species":"","study_id":"sccs_o_195_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=5000; DOSE=ve, urea nitrogen was increased in both sexes at 20,000 ppm and at 10,000 ppm in females.; EFFECT=ve, urea nitrogen was increased in both sexes at 20,000 ppm and at 10,000 ppm in females. These observations are all considered treatment-related toxicologically significant effects. Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm. The decrease in platelets at 5000 ppm was not considered relevant for the establishment of the NOAEL due to the minimal degree of the effect and the absence of any functional impact on coagulation at any dose. Based on the overall weight of the evidence, the NOAEL is considered to be 5000 ppm corresponding; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"ve, urea nitrogen was increased in both sexes at 20,000 ppm and at 10,000 ppm in females.","duration":"","effect":"ve, urea nitrogen was increased in both sexes at 20,000 ppm and at 10,000 ppm in females. These observations are all considered treatment-related toxicologically significant effects. Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm. The decrease in platelets at 5000 ppm was not considered relevant for the establishment of the NOAEL due to the minimal degree of the effect and the absence of any functional impact on coagulation at any dose. Based on the overall weight of the evidence, the NOAEL is considered to be 5000 ppm corresponding","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":25,"route":"","species":"","study_id":"sccs_o_195_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=5000; DOSE=Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm.; EFFECT=gnificant effects. Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm. The decrease in platelets at 5000 ppm was not considered relevant for the establishment of the NOAEL due to the minimal degree of the effect and the absence of any functional impact on coagulation at any dose. Based on the overall weight of the evidence, the NOAEL is considered to be 5000 ppm corresponding; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm.","duration":"","effect":"gnificant effects. Conclusion The critical effects in this study pertinent to the establishment of the NOAEL are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥ 10,000 ppm. The decrease in platelets at 5000 ppm was not considered relevant for the establishment of the NOAEL due to the minimal degree of the effect and the absence of any functional impact on coagulation at any dose. Based on the overall weight of the evidence, the NOAEL is considered to be 5000 ppm corresponding","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":25,"route":"","species":"","study_id":"sccs_o_195_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/day |
rabbit |
dermal |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=500; DOSE=slight scaling in male and female rabbits of the 500 mg/kg bw/day dose group.; EFFECT=SCCS-rejected applicant NOAEL: slight scaling in male and female rabbits of the 500 mg/kg bw/day dose group. These changes were not associated with gross or histopathological changes and were not considered toxicologically significant. There were no treatment-related gross pathologic or histopathological changes observed in either males or females at 500 mg/kg bw/day. Conclusion Based on the lack of treatment-related effects on body weight, organ weights, haematological and clinical chemistries and gross and histopathological examinations, the no-observed-adverse-effect level (NOAEL) for systemic toxicity was concluded to be 500 mg/kg bw/day under the conditions of this study. Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline. However, the report fulfils the formal, methodological and data criteria of the OECD testing guideline 411 (1981). The SCCS considers this study as a key study for the safety assessment of 2- phenoxyethanol because the dermal route is the relevant route for 2-phenoxyethanol as a cosmetic ingredient and the rabbit ha; CITATION=Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline; CITATION_NUMBERS=[12,13]; REFERENCE=Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline","dose":"slight scaling in male and female rabbits of the 500 mg/kg bw/day dose group.","duration":"","effect":"SCCS-rejected applicant NOAEL: slight scaling in male and female rabbits of the 500 mg/kg bw/day dose group. These changes were not associated with gross or histopathological changes and were not considered toxicologically significant. There were no treatment-related gross pathologic or histopathological changes observed in either males or females at 500 mg/kg bw/day. Conclusion Based on the lack of treatment-related effects on body weight, organ weights, haematological and clinical chemistries and gross and histopathological examinations, the no-observed-adverse-effect level (NOAEL) for systemic toxicity was concluded to be 500 mg/kg bw/day under the conditions of this study. Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline. However, the report fulfils the formal, methodological and data criteria of the OECD testing guideline 411 (1981). The SCCS considers this study as a key study for the safety assessment of 2- phenoxyethanol because the dermal route is the relevant route for 2-phenoxyethanol as a cosmetic ingredient and the rabbit ha","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":28,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/day |
rabbit |
dermal |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=500; DOSE=rabbits of the 500 mg/kg bw/day dose group.; EFFECT=SCCS-rejected applicant NOAEL: rabbits of the 500 mg/kg bw/day dose group. These changes were not associated with gross or histopathological changes and were not considered toxicologically significant. There were no treatment-related gross pathologic or histopathological changes observed in either males or females at 500 mg/kg bw/day. Conclusion Based on the lack of treatment-related effects on body weight, organ weights, haematological and clinical chemistries and gross and histopathological examinations, the no-observed-adverse-effect level (NOAEL) for systemic toxicity was concluded to be 500 mg/kg bw/day under the conditions of this study. Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline. However, the report fulfils the formal, methodological and data criteria of the OECD testing guideline 411 (1981). The SCCS considers this study as a key study for the safety assessment of 2- phenoxyethanol because the dermal route is the relevant route for 2-phenoxyethanol as a cosmetic ingredient and the rabbit has been; CITATION=Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline; CITATION_NUMBERS=[12,13]; REFERENCE=Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline","dose":"rabbits of the 500 mg/kg bw/day dose group.","duration":"","effect":"SCCS-rejected applicant NOAEL: rabbits of the 500 mg/kg bw/day dose group. These changes were not associated with gross or histopathological changes and were not considered toxicologically significant. There were no treatment-related gross pathologic or histopathological changes observed in either males or females at 500 mg/kg bw/day. Conclusion Based on the lack of treatment-related effects on body weight, organ weights, haematological and clinical chemistries and gross and histopathological examinations, the no-observed-adverse-effect level (NOAEL) for systemic toxicity was concluded to be 500 mg/kg bw/day under the conditions of this study. Ref.: 12, 13 SCCS Comment The study report does not contain a statement on the testing guideline. However, the report fulfils the formal, methodological and data criteria of the OECD testing guideline 411 (1981). The SCCS considers this study as a key study for the safety assessment of 2- phenoxyethanol because the dermal route is the relevant route for 2-phenoxyethanol as a cosmetic ingredient and the rabbit has been","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":28,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
10000 |
ppm |
mouse |
oral |
13-week |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=10,000; DOSE=erol and phospholipids at ≥ 10,000 ppm and a decrease in triglycerides at 20,000 ppm in males.; EFFECT=erol and phospholipids at ≥ 10,000 ppm and a decrease in triglycerides at 20,000 ppm in males. In the study summary report, these effects were concluded not to be clearly related to the administration of the 2-phenoxyethanol. There was no evidence of any histopathology in the liver and no increase in liver enzymes (ALT, AST). However, similar effects on cholesterol and phospholipids were observed in the 13-week drinking water study in the same strain of mice and these were very conservatively used to establish the NOAEL for that study. Therefore, these findings in males in the chronic study were also conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). No statistically significant changes of organ weights or biochemistry parameters were observed at the low dose (5,000 ppm). Therefore, the no-observed-adv; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"erol and phospholipids at ≥ 10,000 ppm and a decrease in triglycerides at 20,000 ppm in males.","duration":"13-week","effect":"erol and phospholipids at ≥ 10,000 ppm and a decrease in triglycerides at 20,000 ppm in males. In the study summary report, these effects were concluded not to be clearly related to the administration of the 2-phenoxyethanol. There was no evidence of any histopathology in the liver and no increase in liver enzymes (ALT, AST). However, similar effects on cholesterol and phospholipids were observed in the 13-week drinking water study in the same strain of mice and these were very conservatively used to establish the NOAEL for that study. Therefore, these findings in males in the chronic study were also conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). No statistically significant changes of organ weights or biochemistry parameters were observed at the low dose (5,000 ppm). Therefore, the no-observed-adv","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"10,000","page":40,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
- |
oral |
chronic |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=5,000; DOSE=Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls).; EFFECT=blish the NOAEL for that study. Therefore, these findings in males in the chronic study were also conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). No statistically significant changes of organ weights or biochemistry parameters were observed at the low dose (5,000 ppm). Therefore, the no-observed-adverse-effect level (NOAEL) for 2-phenoxyethanol in this study was concluded to be 5000 ppm in drinking water,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls).","duration":"chronic","effect":"blish the NOAEL for that study. Therefore, these findings in males in the chronic study were also conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). No statistically significant changes of organ weights or biochemistry parameters were observed at the low dose (5,000 ppm). Therefore, the no-observed-adverse-effect level (NOAEL) for 2-phenoxyethanol in this study was concluded to be 5000 ppm in drinking water,","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"5,000","page":40,"route":"oral","species":"","study_id":"sccs_o_195_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5000 |
ppm |
- |
oral |
chronic |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=5,000; DOSE=Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls).; EFFECT=erefore, these findings in males in the chronic study were also conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). No statistically significant changes of organ weights or biochemistry parameters were observed at the low dose (5,000 ppm). Therefore, the no-observed-adverse-effect level (NOAEL) for 2-phenoxyethanol in this study was concluded to be 5000 ppm in drinking water,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls).","duration":"chronic","effect":"erefore, these findings in males in the chronic study were also conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). No statistically significant changes of organ weights or biochemistry parameters were observed at the low dose (5,000 ppm). Therefore, the no-observed-adverse-effect level (NOAEL) for 2-phenoxyethanol in this study was concluded to be 5000 ppm in drinking water,","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"5,000","page":40,"route":"oral","species":"","study_id":"sccs_o_195_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2 |
mg/kg |
- |
intravenous |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=2; DOSE=After intravenous injection, PE was extensively converted to PAA, with the average PAA to PE AUC ratio (AUCPAA/AUCPE) of 5.2, 4.5, and 5.0 for the intravenous doses of 0.2, 0.5 and 2 mg/kg, respectively.; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 57 sampling time period (e.g., >3 t1/2) at concentrations two orders of magnitude lower than the NOAEL range. The assay achieved the LLOQ of 10 and 20 ng/mL of PE and PAA, respectively, for plasma samples and the LLOQ of 20 and 50 ng/mL of PE and PAA, respectively, for urine and tissue samples. Intravenous injection study: Kinetic parameter values are listed in Table X1. After intravenous injection, PE was extensively converted to PAA, with the average PAA to PE AUC ratio (AUCPAA/AUCPE) of 5.2, 4.5, and 5.0 for the intravenous doses of 0.2, 0.5 and 2 mg/kg, respectively. The disposition of PE was characterised by; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"After intravenous injection, PE was extensively converted to PAA, with the average PAA to PE AUC ratio (AUCPAA/AUCPE) of 5.2, 4.5, and 5.0 for the intravenous doses of 0.2, 0.5 and 2 mg/kg, respectively.","duration":"","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 57 sampling time period (e.g., >3 t1/2) at concentrations two orders of magnitude lower than the NOAEL range. The assay achieved the LLOQ of 10 and 20 ng/mL of PE and PAA, respectively, for plasma samples and the LLOQ of 20 and 50 ng/mL of PE and PAA, respectively, for urine and tissue samples. Intravenous injection study: Kinetic parameter values are listed in Table X1. After intravenous injection, PE was extensively converted to PAA, with the average PAA to PE AUC ratio (AUCPAA/AUCPE) of 5.2, 4.5, and 5.0 for the intravenous doses of 0.2, 0.5 and 2 mg/kg, respectively. The disposition of PE was characterised by","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg","noael_value":"2","page":57,"route":"intravenous","species":"","study_id":"sccs_o_195_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
% |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1; DOSE=Based on conservative aggregate product use assumptions, model-predicted internal exposures to PE associated with oral care and cosmetic product use in adult humans and baby care product use in infants were well below the internal exposures to PE in rats at the NOAEL dose.; EFFECT=in dosimetry predictions and support refinement of the default interspecies toxicokinetic uncertainty factor from 4 to 1. Therefore, the use of an overall margin of safety (MoS) value of 25 rather than the default value of 100 can be considered acceptable. Based on conservative aggregate product use assumptions, model-predicted internal exposures to PE associated with oral care and cosmetic product use in adult humans and baby care product use in infants were well below the internal exposures to PE in rats at the NOAEL dose. Calculated MoS values for PE for aggregate cosmetic use scenarios previously described in Submission I ranged from 39-359 (Table 8; see also Annex 1). For all exposure scenarios, calculated MoS values were well above the PBPK-refined margin of safety value of 25, supporting the safe use of PhE- containing products at a concentration up to 1% in both adults and babies.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Based on conservative aggregate product use assumptions, model-predicted internal exposures to PE associated with oral care and cosmetic product use in adult humans and baby care product use in infants were well below the internal exposures to PE in rats at the NOAEL dose.","duration":"","effect":"in dosimetry predictions and support refinement of the default interspecies toxicokinetic uncertainty factor from 4 to 1. Therefore, the use of an overall margin of safety (MoS) value of 25 rather than the default value of 100 can be considered acceptable. Based on conservative aggregate product use assumptions, model-predicted internal exposures to PE associated with oral care and cosmetic product use in adult humans and baby care product use in infants were well below the internal exposures to PE in rats at the NOAEL dose. Calculated MoS values for PE for aggregate cosmetic use scenarios previously described in Submission I ranged from 39-359 (Table 8; see also Annex 1). For all exposure scenarios, calculated MoS values were well above the PBPK-refined margin of safety value of 25, supporting the safe use of PhE- containing products at a concentration up to 1% in both adults and babies.","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"1","page":60,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1575 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 61 Table 8 Margin of Safety (MoS) calculations for aggregate 2-phenoxyethanol exposures to adults and infants/children of 8 kg body weight External dose AUC (mg*h/L) MoS Sub/population Description mg/kg/day BW (kg) PhE PhAA PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 - - Human (adult) Aggregate Cosmetics 2.69 60 0.608 8.82 101 78 Human (infant) Daily Baby Care (Part 1) a 1.72 8 0.279 3.19 220 217 Human (infant) Part 2a (Leave-on/nappy) 2.64 8 1.04 12.0 59 58 Human (infant) Part 2b (wipes/nappy) 2.00 8 0.97 11.1 63 62 Human (infant) Parts 1+2a+2b 6.36 8 2.29 26.3 27 26 Subm II, ref. 12 SCCS comment The PBPK model was mainly developed by use of oral rat kinetic data. Whereas the human data described in sections 3.3.9.3 and 3.3.11 were also use; DOSE=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 61 Table 8 Margin of Safety (MoS) calculations for aggregate 2-phenoxyethanol exposures to adults and infants/children of 8 kg body weight External dose AUC (mg*h/L) MoS Sub/population Descriptio...; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 61 Table 8 Margin of Safety (MoS) calculations for aggregate 2-phenoxyethanol exposures to adults and infants/children of 8 kg body weight External dose AUC (mg*h/L) MoS Sub/population Description mg/kg/day BW (kg) PhE PhAA PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 - - Human (adult) Aggregate Cosmetics 2.69 60 0.608 8.82 101 78 Human (infant) Daily Baby Care (Part 1) a 1.72 8 0.279 3.19 220 217 Human (infant) Part 2a (Leave-on/nappy) 2.64 8 1.04 12.0 59 58 Human (infant) Part 2b (wipes/nappy) 2.00 8 0.97 11.1 63 62 Human (infant) Parts 1+2a+2b 6.36 8 2.29 26.3 27 26 Subm II, ref. 12 SCCS comment The PBPK model was mainly developed by use of oral rat kinetic data. Whereas the human data described in sections 3.3.9.3 and 3.3.11 were also use; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 61 Table 8 Margin of Safety (MoS) calculations for aggregate 2-phenoxyethanol exposures to adults and infants/children of 8 kg body weight External dose AUC (mg*h/L) MoS Sub/population Descriptio...","duration":"","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 61 Table 8 Margin of Safety (MoS) calculations for aggregate 2-phenoxyethanol exposures to adults and infants/children of 8 kg body weight External dose AUC (mg*h/L) MoS Sub/population Description mg/kg/day BW (kg) PhE PhAA PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 - - Human (adult) Aggregate Cosmetics 2.69 60 0.608 8.82 101 78 Human (infant) Daily Baby Care (Part 1) a 1.72 8 0.279 3.19 220 217 Human (infant) Part 2a (Leave-on/nappy) 2.64 8 1.04 12.0 59 58 Human (infant) Part 2b (wipes/nappy) 2.00 8 0.97 11.1 63 62 Human (infant) Parts 1+2a+2b 6.36 8 2.29 26.3 27 26 Subm II, ref. 12 SCCS comment The PBPK model was mainly developed by use of oral rat kinetic data. Whereas the human data described in sections 3.3.9.3 and 3.3.11 were also use","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 61 Table 8 Margin of Safety (MoS) calculations for aggregate 2-phenoxyethanol exposures to adults and infants/children of 8 kg body weight External dose AUC (mg*h/L) MoS Sub/population Description mg/kg/day BW (kg) PhE PhAA PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 - - Human (adult) Aggregate Cosmetics 2.69 60 0.608 8.82 101 78 Human (infant) Daily Baby Care (Part 1) a 1.72 8 0.279 3.19 220 217 Human (infant) Part 2a (Leave-on/nappy) 2.64 8 1.04 12.0 59 58 Human (infant) Part 2b (wipes/nappy) 2.00 8 0.97 11.1 63 62 Human (infant) Parts 1+2a+2b 6.36 8 2.29 26.3 27 26 Subm II, ref. 12 SCCS comment The PBPK model was mainly developed by use of oral rat kinetic data. Whereas the human data described in sections 3.3.9.3 and 3.3.11 were also use","page":61,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2.69 |
mg/kg/d |
rat |
dermal |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=2.69; DOSE=5 0.087 0.0949 a) For the aggregate daily dose of 2.69 mg/kg/d in adult humans, the following values result:; EFFECT=5 0.087 0.0949 a) For the aggregate daily dose of 2.69 mg/kg/d in adult humans, the following values result: AUCPhE = 2.09 and AUCPhAA = 22.0 mg*h/L, respectively. SCCS comment The updated PBPK data for dose metric AUC of phenoxyethanol (AUCPhE) in adult humans (last line of table 11) are around 3-fold higher than those predicted by Troutman et al. (2015, subm II, ref. 12; see Table 8) resulting in MoS values of around 30 for adults when comparing AUCPhE in human adults with the respective AUC value in rats at the NOAEL (Table 8). This considerable increase of internal exposure of adults to phenoxyethanol (and also phenoxyacetic acid) by dermal exposure was not commented by the applicant. No; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"5 0.087 0.0949 a) For the aggregate daily dose of 2.69 mg/kg/d in adult humans, the following values result:","duration":"","effect":"5 0.087 0.0949 a) For the aggregate daily dose of 2.69 mg/kg/d in adult humans, the following values result: AUCPhE = 2.09 and AUCPhAA = 22.0 mg*h/L, respectively. SCCS comment The updated PBPK data for dose metric AUC of phenoxyethanol (AUCPhE) in adult humans (last line of table 11) are around 3-fold higher than those predicted by Troutman et al. (2015, subm II, ref. 12; see Table 8) resulting in MoS values of around 30 for adults when comparing AUCPhE in human adults with the respective AUC value in rats at the NOAEL (Table 8). This considerable increase of internal exposure of adults to phenoxyethanol (and also phenoxyacetic acid) by dermal exposure was not commented by the applicant. No","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg/d","noael_value":"2.69","page":63,"route":"dermal","species":"rat","study_id":"sccs_o_195_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=2.69 |
mg/kg bw/day |
rabbit |
dermal |
90-day |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT== 2.69; DOSE=Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adju...; EFFECT=tathione were observed. An in vitro experiment with rabbit red blood cells indicates that 2-phenoxyethanol is considerably more haemolytic than its major metabolite, 2-phenoxyacetic acid (see also ref. 12, ref. 36). Ref.: 37 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Adults: Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adjusted NOAEL/SED = 130 * See chapter 4-2 of the SCCS’ Notes of Guidance Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits (the most sensitive species towards 2-phenoxyethanol), the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum MoS of 25 instead of 100 for the; CITATION=Ref.: 37 3; CITATION_NUMBERS=[37,3]; REFERENCE=Ref.: 37 3; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 37 3","dose":"Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adju...","duration":"90-day","effect":"tathione were observed. An in vitro experiment with rabbit red blood cells indicates that 2-phenoxyethanol is considerably more haemolytic than its major metabolite, 2-phenoxyacetic acid (see also ref. 12, ref. 36). Ref.: 37 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Adults: Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adjusted NOAEL/SED = 130 * See chapter 4-2 of the SCCS’ Notes of Guidance Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits (the most sensitive species towards 2-phenoxyethanol), the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum MoS of 25 instead of 100 for the","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"= 2.69","page":72,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=357 |
mg/kg bw/d |
rabbit |
dermal |
90-day |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT== 357; DOSE=Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adju...; EFFECT=onsiderably more haemolytic than its major metabolite, 2-phenoxyacetic acid (see also ref. 12, ref. 36). Ref.: 37 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Adults: Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adjusted NOAEL/SED = 130 * See chapter 4-2 of the SCCS’ Notes of Guidance Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits (the most sensitive species towards 2-phenoxyethanol), the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum MoS of 25 instead of 100 for the; CITATION=Ref.: 37 3; CITATION_NUMBERS=[37,3]; REFERENCE=Ref.: 37 3; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 37 3","dose":"Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adju...","duration":"90-day","effect":"onsiderably more haemolytic than its major metabolite, 2-phenoxyacetic acid (see also ref. 12, ref. 36). Ref.: 37 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Adults: Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adjusted NOAEL/SED = 130 * See chapter 4-2 of the SCCS’ Notes of Guidance Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits (the most sensitive species towards 2-phenoxyethanol), the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum MoS of 25 instead of 100 for the","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 357","page":72,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
=357 |
mg/kg bw/d |
rabbit |
dermal |
90-day |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT== 357; DOSE=Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adju...; EFFECT=henoxyacetic acid (see also ref. 12, ref. 36). Ref.: 37 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Adults: Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adjusted NOAEL/SED = 130 * See chapter 4-2 of the SCCS’ Notes of Guidance Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits (the most sensitive species towards 2-phenoxyethanol), the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum MoS of 25 instead of 100 for the; CITATION=Ref.: 37 3; CITATION_NUMBERS=[37,3]; REFERENCE=Ref.: 37 3; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 37 3","dose":"Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adju...","duration":"90-day","effect":"henoxyacetic acid (see also ref. 12, ref. 36). Ref.: 37 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Adults: Daily aggregate exposure for preservatives* A = 269 mg/kg bw/day (default value for adults) Max. concentration in the final product(s) C = 1% External exposure dose = 2.69 mg/kg bw/day No observed adverse effect level (90-day, dermal, rabbit, 500 mg/kg bw/day adjusted for 5 days exposure/week) NOAEL = 357 mg/kg bw/d Margin of Safety, adults adjusted NOAEL/SED = 130 * See chapter 4-2 of the SCCS’ Notes of Guidance Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits (the most sensitive species towards 2-phenoxyethanol), the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum MoS of 25 instead of 100 for the","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 357","page":72,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
357 |
mg/kg bw/day |
rabbit |
dermal |
90-day |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=357; DOSE=A MoS of 130 was derived for adult humans using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits.; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 73 safety assessment of 2-phenoxyethanol. A MoS of 130 was derived for adult humans using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits. MoS for children Whereas children ≤3 years may be higher exposed than adults to 2-phenoxyethanol in cosmetic products, MoS values of around 50 were derived from reasonable worst case scenarios (Troutman et al. 2015, subm II, ref. 12; ANSM 2012, AR 15) (see Discussion). Therefore, the span of these MoS values of around 50 to the minimum MoS of 25 also covers the safety of newborns/infants, who may have a higher exposure to 2- phenoxyethanol exposure in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"A MoS of 130 was derived for adult humans using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits.","duration":"90-day","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 73 safety assessment of 2-phenoxyethanol. A MoS of 130 was derived for adult humans using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits. MoS for children Whereas children ≤3 years may be higher exposed than adults to 2-phenoxyethanol in cosmetic products, MoS values of around 50 were derived from reasonable worst case scenarios (Troutman et al. 2015, subm II, ref. 12; ANSM 2012, AR 15) (see Discussion). Therefore, the span of these MoS values of around 50 to the minimum MoS of 25 also covers the safety of newborns/infants, who may have a higher exposure to 2- phenoxyethanol exposure in","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"357","page":73,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rabbit |
dermal |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL:; EFFECT=dies: Dow Chemicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500 x 5/7 = 357 GLP study, equivalent to OECD guideline 411. Also published report.; CITATION=(ref 17); CITATION_NUMBERS=[17]; REFERENCE=(ref 17); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref 17)","dose":"0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL:","duration":"90 days","effect":"dies: Dow Chemicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500 x 5/7 = 357 GLP study, equivalent to OECD guideline 411. Also published report.","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":74,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rabbit |
dermal |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL:; EFFECT=emicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500 x 5/7 = 357 GLP study, equivalent to OECD guideline 411. Also published report.; CITATION=(ref 17); CITATION_NUMBERS=[17]; REFERENCE=(ref 17); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref 17)","dose":"0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL:","duration":"90 days","effect":"emicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500 x 5/7 = 357 GLP study, equivalent to OECD guideline 411. Also published report.","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":74,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/day |
rabbit |
dermal |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=500; DOSE=1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation;; EFFECT=600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500 x 5/7 = 357 GLP study, equivalent to OECD guideline 411. Also published report.; CITATION=(ref 18); CITATION_NUMBERS=[18]; REFERENCE=(ref 18); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref 18)","dose":"1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation;","duration":"90 days","effect":"600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500 x 5/7 = 357 GLP study, equivalent to OECD guideline 411. Also published report.","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":74,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rat |
oral |
10 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL:; LOAEL_VALUE=1000 mg/kg bw/day; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 75 Oral studies: Breslin et al. 1991, Ref. 12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL: 100 Published report BASF AG, 2006, (ref. 16) Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) NOAEL: 300 (NOAEL offspring: 1000) GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver:; CITATION=(ref. 16); CITATION_NUMBERS=[16]; REFERENCE=(ref. 16); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 16)","dose":"12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL:","duration":"10 days","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 75 Oral studies: Breslin et al. 1991, Ref. 12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL: 100 Published report BASF AG, 2006, (ref. 16) Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) NOAEL: 300 (NOAEL offspring: 1000) GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver:","endpoint":"","ingredient":"codes .................................... 6","loael_value":"1000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"1000","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rat |
oral |
10 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL:; LOAEL_VALUE=1000 mg/kg bw/day; EFFECT=/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 75 Oral studies: Breslin et al. 1991, Ref. 12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL: 100 Published report BASF AG, 2006, (ref. 16) Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) NOAEL: 300 (NOAEL offspring: 1000) GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight; CITATION=(ref. 16); CITATION_NUMBERS=[16]; REFERENCE=(ref. 16); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 16)","dose":"12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL:","duration":"10 days","effect":"/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 75 Oral studies: Breslin et al. 1991, Ref. 12 Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL: 100 Published report BASF AG, 2006, (ref. 16) Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) NOAEL: 300 (NOAEL offspring: 1000) GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight","endpoint":"","ingredient":"codes .................................... 6","loael_value":"1000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"1000","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
164 |
mg/kg bw/day |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=164; DOSE=, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL:; LOAEL_VALUE=1000 mg/kg bw/day; EFFECT=, 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL: 100 Published report BASF AG, 2006, (ref. 16) Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) NOAEL: 300 (NOAEL offspring: 1000) GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL: 164 Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Dose; CITATION=(ref. 16); CITATION_NUMBERS=[16]; REFERENCE=(ref. 16); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 16)","dose":", 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL:","duration":"90 days","effect":", 1000 mg/kg bw/day Haematotoxicity in all dose groups LOAEL: 100 Published report BASF AG, 2006, (ref. 16) Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) NOAEL: 300 (NOAEL offspring: 1000) GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL: 164 Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Dose","endpoint":"","ingredient":"codes .................................... 6","loael_value":"1000 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"164","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
164 |
mg/kg bw/day |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=164; DOSE=Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL:; EFFECT=inical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL: 164 Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163,; CITATION=(ref. 10); CITATION_NUMBERS=[10]; REFERENCE=(ref. 10); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 10)","dose":"Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL:","duration":"90 days","effect":"inical chemistry and haematotoxicity parameters Bayer AG, 2002 (ref. 10) Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. NOAEL: 697 (males) GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL: 164 Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163,","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"164","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
164 |
mg/kg bw/day |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=164; DOSE=Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL:; EFFECT=food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL: 164 Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinki; CITATION=(ref. 11); CITATION_NUMBERS=[11]; REFERENCE=(ref. 11); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 11)","dose":"Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL:","duration":"90 days","effect":"food and water intake in all groups including the control group. Study not reliable Unilever, 1993 (ref. 11) Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day NOAEL: 164 Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinki","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"164","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1977 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:udy downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249,; DOSE=Males: inflammation of kidney at mid dose NOEL:; EFFECT=udy downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249,; CITATION=(ref. 40); CITATION_NUMBERS=[40]; REFERENCE=(ref. 40); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 40)","dose":"Males: inflammation of kidney at mid dose NOEL:","duration":"90 days","effect":"udy downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249,","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:udy downgraded to non- GLP for unclear reasons. Study not reliable NIPA Labs, 1977 (ref. 40) SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. Males: inflammation of kidney at mid dose NOEL: 80 Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249,","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_044"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2002 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref; DOSE=0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study.; EFFECT=substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study.","duration":"90 days","effect":"substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:substance unknown. Study not reliable MHLW Japan, 2002 (subm. II, ref.1) F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 Haematotoxicity, kidney, bladder NOAEL: 369 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_045"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2002 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref; DOSE=0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study.; EFFECT=, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study.","duration":"90 days","effect":", 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:, 2002 (subm. II, ref.2) B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 Liver NOAEL: 390 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.3) F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_046"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
500 |
mg/kg bw/day |
rat |
oral |
77 day |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=500; DOSE=To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day.; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 77 day per week basis, for a period of 90 days. However, based primarily on practical considerations, application on a 5-day per week basis is considered to be acceptable.” The 90-day dermal toxicity study conducted with 2-phenoxyethanol is therefore considered acceptable within the OECD guidelines. To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day. Oral exposure Several oral studies from three species are available: rat, mouse and rabbit, rabbit being the most sensitive species of these three species. Rabbits received 2-phenoxyethanol orally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days. While 1 animal died in the 300 mg/kg dose group, none of the animals in either high dose group died due to severe haematotoxicity. Signs of haematotoxi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day.","duration":"77 day","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 77 day per week basis, for a period of 90 days. However, based primarily on practical considerations, application on a 5-day per week basis is considered to be acceptable.” The 90-day dermal toxicity study conducted with 2-phenoxyethanol is therefore considered acceptable within the OECD guidelines. To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day. Oral exposure Several oral studies from three species are available: rat, mouse and rabbit, rabbit being the most sensitive species of these three species. Rabbits received 2-phenoxyethanol orally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days. While 1 animal died in the 300 mg/kg dose group, none of the animals in either high dose group died due to severe haematotoxicity. Signs of haematotoxi","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":77,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_051"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
357 |
mg/kg bw/day |
rat |
oral |
77 day |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=357; DOSE=To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day.; EFFECT=________________________________________________________________________ 77 day per week basis, for a period of 90 days. However, based primarily on practical considerations, application on a 5-day per week basis is considered to be acceptable.” The 90-day dermal toxicity study conducted with 2-phenoxyethanol is therefore considered acceptable within the OECD guidelines. To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day. Oral exposure Several oral studies from three species are available: rat, mouse and rabbit, rabbit being the most sensitive species of these three species. Rabbits received 2-phenoxyethanol orally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days. While 1 animal died in the 300 mg/kg dose group, none of the animals in either high dose group died due to severe haematotoxicity. Signs of haematotoxicity were observed in all dose groups. In rabbits gavaged with 100 or 300 mg/kg bw, tr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day.","duration":"77 day","effect":"________________________________________________________________________ 77 day per week basis, for a period of 90 days. However, based primarily on practical considerations, application on a 5-day per week basis is considered to be acceptable.” The 90-day dermal toxicity study conducted with 2-phenoxyethanol is therefore considered acceptable within the OECD guidelines. To account for the dosing schedule used in this study, the NOAEL of 500 mg/kg bw/day should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day. Oral exposure Several oral studies from three species are available: rat, mouse and rabbit, rabbit being the most sensitive species of these three species. Rabbits received 2-phenoxyethanol orally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days. While 1 animal died in the 300 mg/kg dose group, none of the animals in either high dose group died due to severe haematotoxicity. Signs of haematotoxicity were observed in all dose groups. In rabbits gavaged with 100 or 300 mg/kg bw, tr","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"357","page":77,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_052"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
10000 |
ppm |
rat |
oral |
10 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=10,000; DOSE=rally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days.; LOAEL_VALUE=100 mg/kg bw/day; EFFECT=rally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days. While 1 animal died in the 300 mg/kg dose group, none of the animals in either high dose group died due to severe haematotoxicity. Signs of haematotoxicity were observed in all dose groups. In rabbits gavaged with 100 or 300 mg/kg bw, treatment- related microscopic changes were observed in the spleen. The LOAEL of this study is 100 mg/kg bw/day. A 90-day guideline study in rats from 2002 was conducted with 0, 500, 2500 and 10,000 ppm in diet. The NOAEL was concluded to be the high dose of 10,000 ppm in diet corresponding to an intake of 697 mg/kg bw/day in males and 939 mg/kg bw/day in females (ref. 10). However, in control groups and in all treatment groups, parameters of food intake, water intake and body weight gain declined during the study and persisted during the recovery period. These unusual data were not commented upon and not explained. It is assumed that the animals of this study were ill, potentially due to an infection. The study is considered of li; CITATION=(ref. 10); CITATION_NUMBERS=[10]; REFERENCE=(ref. 10); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 10)","dose":"rally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days.","duration":"10 days","effect":"rally by gavage at 100, 300, 600, or 1000 mg/kg bw/day for 10 days. While 1 animal died in the 300 mg/kg dose group, none of the animals in either high dose group died due to severe haematotoxicity. Signs of haematotoxicity were observed in all dose groups. In rabbits gavaged with 100 or 300 mg/kg bw, treatment- related microscopic changes were observed in the spleen. The LOAEL of this study is 100 mg/kg bw/day. A 90-day guideline study in rats from 2002 was conducted with 0, 500, 2500 and 10,000 ppm in diet. The NOAEL was concluded to be the high dose of 10,000 ppm in diet corresponding to an intake of 697 mg/kg bw/day in males and 939 mg/kg bw/day in females (ref. 10). However, in control groups and in all treatment groups, parameters of food intake, water intake and body weight gain declined during the study and persisted during the recovery period. These unusual data were not commented upon and not explained. It is assumed that the animals of this study were ill, potentially due to an infection. The study is considered of li","endpoint":"","ingredient":"codes .................................... 6","loael_value":"100 mg/kg bw/day","noael_unit":"ppm","noael_value":"10,000","page":77,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_053"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
79 |
% |
rat |
oral |
13-week |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=79; DOSE=Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls).; EFFECT=iver enzymes (ALT, AST). However, similar effects on cholesterol and phospholipids were observed in the 13-week drinking water study in the same strain of mice. Therefore, these findings in males in the chronic study were conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). Therefore, the NOAEL for 2-phenoxyethanol in this study was concluded to be 5000 ppm in drinking water, corresponding to an intake of 468 mg/kg bw/day in males and 586 mg/kg bw/day in females. Conclusion on RDT studies The available oral studies indicate that the rabbit is the most sensitive of the species tested, mainly due to its susceptibility to haematotoxic effects. Target organs in rats and mice were the kidney and liver, probably due to an extensive first-pass metabolism and formation of high amounts/concentrations of 2-pheno; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls).","duration":"13-week","effect":"iver enzymes (ALT, AST). However, similar effects on cholesterol and phospholipids were observed in the 13-week drinking water study in the same strain of mice. Therefore, these findings in males in the chronic study were conservatively concluded to be treatment related. Furthermore, the significant effects on body weight gain indicate that the maximum tolerated dose was exceeded in males at 10,000 ppm in males (body weight 84% of controls) and in females at 20,000 ppm (body weight 79% of controls). Therefore, the NOAEL for 2-phenoxyethanol in this study was concluded to be 5000 ppm in drinking water, corresponding to an intake of 468 mg/kg bw/day in males and 586 mg/kg bw/day in females. Conclusion on RDT studies The available oral studies indicate that the rabbit is the most sensitive of the species tested, mainly due to its susceptibility to haematotoxic effects. Target organs in rats and mice were the kidney and liver, probably due to an extensive first-pass metabolism and formation of high amounts/concentrations of 2-pheno","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"79","page":78,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_057"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2015 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:effect. During the commenting phase of the Opinion, modified data was provided by the applicant using the additional toxicokinetic data after topical exposure of rats (Kim et al. (2015, ref. AR 9). The updated PBPK data for the dose metric AUC of phenoxyethanol in adult humans (Table 11) were around 3-fold higher than those predicted by Troutman et al. (2015, subm II, ref. 12; Table 8) resulting in MoS values of around 30 for adults when comparing AUCPhe in human adults with the respective AUC value in rats at the NOAEL (Table 8). No supplementing data were provided for infants/children exposure groups, for which the resulting MoS values may be around 10-15. The rat PBPK model can reproduce the chemical-specific pharmacokinetic data under various experimental conditions for oral route and dermal application and is reliable with regard to its predictions of dose metrics (Cmax AUC, renal clearance). Regarding the human PBPK model, the PBPK model can reproduce the chemical-specific pharmacokinetic data under two experimental condi; DOSE=The updated PBPK data for the dose metric AUC of phenoxyethanol in adult humans (Table 11) were around 3-fold higher than those predicted by Troutman et al.; EFFECT=effect. During the commenting phase of the Opinion, modified data was provided by the applicant using the additional toxicokinetic data after topical exposure of rats (Kim et al. (2015, ref. AR 9). The updated PBPK data for the dose metric AUC of phenoxyethanol in adult humans (Table 11) were around 3-fold higher than those predicted by Troutman et al. (2015, subm II, ref. 12; Table 8) resulting in MoS values of around 30 for adults when comparing AUCPhe in human adults with the respective AUC value in rats at the NOAEL (Table 8). No supplementing data were provided for infants/children exposure groups, for which the resulting MoS values may be around 10-15. The rat PBPK model can reproduce the chemical-specific pharmacokinetic data under various experimental conditions for oral route and dermal application and is reliable with regard to its predictions of dose metrics (Cmax AUC, renal clearance). Regarding the human PBPK model, the PBPK model can reproduce the chemical-specific pharmacokinetic data under two experimental condi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"The updated PBPK data for the dose metric AUC of phenoxyethanol in adult humans (Table 11) were around 3-fold higher than those predicted by Troutman et al.","duration":"","effect":"effect. During the commenting phase of the Opinion, modified data was provided by the applicant using the additional toxicokinetic data after topical exposure of rats (Kim et al. (2015, ref. AR 9). The updated PBPK data for the dose metric AUC of phenoxyethanol in adult humans (Table 11) were around 3-fold higher than those predicted by Troutman et al. (2015, subm II, ref. 12; Table 8) resulting in MoS values of around 30 for adults when comparing AUCPhe in human adults with the respective AUC value in rats at the NOAEL (Table 8). No supplementing data were provided for infants/children exposure groups, for which the resulting MoS values may be around 10-15. The rat PBPK model can reproduce the chemical-specific pharmacokinetic data under various experimental conditions for oral route and dermal application and is reliable with regard to its predictions of dose metrics (Cmax AUC, renal clearance). Regarding the human PBPK model, the PBPK model can reproduce the chemical-specific pharmacokinetic data under two experimental condi","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:effect. During the commenting phase of the Opinion, modified data was provided by the applicant using the additional toxicokinetic data after topical exposure of rats (Kim et al. (2015, ref. AR 9). The updated PBPK data for the dose metric AUC of phenoxyethanol in adult humans (Table 11) were around 3-fold higher than those predicted by Troutman et al. (2015, subm II, ref. 12; Table 8) resulting in MoS values of around 30 for adults when comparing AUCPhe in human adults with the respective AUC value in rats at the NOAEL (Table 8). No supplementing data were provided for infants/children exposure groups, for which the resulting MoS values may be around 10-15. The rat PBPK model can reproduce the chemical-specific pharmacokinetic data under various experimental conditions for oral route and dermal application and is reliable with regard to its predictions of dose metrics (Cmax AUC, renal clearance). Regarding the human PBPK model, the PBPK model can reproduce the chemical-specific pharmacokinetic data under two experimental condi","page":80,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_062"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
164 |
mg/kg bw/day |
rabbit |
dermal |
3 years |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=164; DOSE=From all toddler/infant-specific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref.; EFFECT=ffect in the human liver. 2-Phenoxyethanol exposure of children For children of ≤3 years of age, the French authority ANSM 1 (2012, ref. AR 15) calculated the specific exposure to cosmetic products with an assumed concentration of 1% 2- phenoxyethanol in the products. Reasonable worst case data of exposure and an unrealistic default body weight of 3.4 kg (for neonates) were used. From all toddler/infant-specific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref. 11). From their data, a reasonable worst case value of 61.2 mg 2-phenoxyethanol per day can be calculated as an external aggregate exposure to age-specific cosmetic products. When using a low default body weight of 9 kg for toddlers/infants ≤3 years (5-percentile; EFSA 2012, AR 16), the daily external exposure is 6.8 mg/kg bw/day and the MoS is 53 when using the NOAEL of 357 mg/kg bw/day from the 90-day dermal toxicity study in rabbits. 1 Agence nationale de sécurité du médi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"From all toddler/infant-specific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref.","duration":"3 years","effect":"ffect in the human liver. 2-Phenoxyethanol exposure of children For children of ≤3 years of age, the French authority ANSM 1 (2012, ref. AR 15) calculated the specific exposure to cosmetic products with an assumed concentration of 1% 2- phenoxyethanol in the products. Reasonable worst case data of exposure and an unrealistic default body weight of 3.4 kg (for neonates) were used. From all toddler/infant-specific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref. 11). From their data, a reasonable worst case value of 61.2 mg 2-phenoxyethanol per day can be calculated as an external aggregate exposure to age-specific cosmetic products. When using a low default body weight of 9 kg for toddlers/infants ≤3 years (5-percentile; EFSA 2012, AR 16), the daily external exposure is 6.8 mg/kg bw/day and the MoS is 53 when using the NOAEL of 357 mg/kg bw/day from the 90-day dermal toxicity study in rabbits. 1 Agence nationale de sécurité du médi","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"164","page":81,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_063"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
357 |
mg/kg bw/day |
rabbit |
dermal |
3 years |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=357; DOSE=ecific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref.; EFFECT=ecific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref. 11). From their data, a reasonable worst case value of 61.2 mg 2-phenoxyethanol per day can be calculated as an external aggregate exposure to age-specific cosmetic products. When using a low default body weight of 9 kg for toddlers/infants ≤3 years (5-percentile; EFSA 2012, AR 16), the daily external exposure is 6.8 mg/kg bw/day and the MoS is 53 when using the NOAEL of 357 mg/kg bw/day from the 90-day dermal toxicity study in rabbits. 1 Agence nationale de sécurité du médicament et des produits de santé; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"ecific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref.","duration":"3 years","effect":"ecific product types, ANSM calculated an SED value of 16.7 mg/kg bw/day and a MoS of 10 by use of an external NOAEL of 164 mg/kg bw/day (derived from ref. 11). From their data, a reasonable worst case value of 61.2 mg 2-phenoxyethanol per day can be calculated as an external aggregate exposure to age-specific cosmetic products. When using a low default body weight of 9 kg for toddlers/infants ≤3 years (5-percentile; EFSA 2012, AR 16), the daily external exposure is 6.8 mg/kg bw/day and the MoS is 53 when using the NOAEL of 357 mg/kg bw/day from the 90-day dermal toxicity study in rabbits. 1 Agence nationale de sécurité du médicament et des produits de santé","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"357","page":81,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_064"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
357 |
mg/kg bw/day |
rat |
oral |
3 years |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=357; DOSE=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 82 When using an even lower body weight default value of EFSA (7 kg, 5-percentile) and the NOAEL of 357 mg/kg bw/day, a daily dose of 8.7 mg/kg bw/day and a MoS of 41 results.; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 82 When using an even lower body weight default value of EFSA (7 kg, 5-percentile) and the NOAEL of 357 mg/kg bw/day, a daily dose of 8.7 mg/kg bw/day and a MoS of 41 results. In conclusion, children ≤3 years may be higher exposed to 2-phenoxyethanol in cosmetic products than adults. However, the MoS values derived from reasonable worst case scenarios are considered sufficient for this age group. Overall safety assessment of 2-phenoxyethanol Haematotoxicity is a predominant toxicological feature of 2-phenoxyethanol in vivo and in vitro. Comparison of oral studies in rats, mice and rabbits indicates that rabbi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 82 When using an even lower body weight default value of EFSA (7 kg, 5-percentile) and the NOAEL of 357 mg/kg bw/day, a daily dose of 8.7 mg/kg bw/day and a MoS of 41 results.","duration":"3 years","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 82 When using an even lower body weight default value of EFSA (7 kg, 5-percentile) and the NOAEL of 357 mg/kg bw/day, a daily dose of 8.7 mg/kg bw/day and a MoS of 41 results. In conclusion, children ≤3 years may be higher exposed to 2-phenoxyethanol in cosmetic products than adults. However, the MoS values derived from reasonable worst case scenarios are considered sufficient for this age group. Overall safety assessment of 2-phenoxyethanol Haematotoxicity is a predominant toxicological feature of 2-phenoxyethanol in vivo and in vitro. Comparison of oral studies in rats, mice and rabbits indicates that rabbi","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"357","page":82,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_065"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
357 |
mg/kg bw/day |
rabbit |
oral |
90-day |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=357; DOSE=Using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits and the aggregate exposure for preservatives in cosmetics, for adult humans a MoS of 130 was derived.; EFFECT=s the relevant route of exposure of humans to 2-phenoxyethanol in cosmetic products, preference is given to dermal studies in rabbits, the most sensitive species tested, whereas the oral route is considered of questionable relevance. Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits, the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2- phenoxyethanol. Using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits and the aggregate exposure for preservatives in cosmetics, for adult humans a MoS of 130 was derived. The large span of this MoS to the MoS of 25 selected by the SCCS for the safety assessment also covers the safety of infants and babies to 2- phenoxyethanol exposure in cosmetic products.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits and the aggregate exposure for preservatives in cosmetics, for adult humans a MoS of 130 was derived.","duration":"90-day","effect":"s the relevant route of exposure of humans to 2-phenoxyethanol in cosmetic products, preference is given to dermal studies in rabbits, the most sensitive species tested, whereas the oral route is considered of questionable relevance. Given the much higher capacity of humans to metabolise 2-phenoxyethanol compared with rabbits, the toxicokinetic default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2- phenoxyethanol. Using an adjusted NOAEL of 357 mg/kg bw/day from a 90-day dermal RDT study in rabbits and the aggregate exposure for preservatives in cosmetics, for adult humans a MoS of 130 was derived. The large span of this MoS to the MoS of 25 selected by the SCCS for the safety assessment also covers the safety of infants and babies to 2- phenoxyethanol exposure in cosmetic products.","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"357","page":82,"route":"oral","species":"rabbit","study_id":"sccs_o_195_noael_066"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1575 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 100 Table 8: Exposure comparisons and internal dosimetry predictions Internal Dose Metric External dose AUC (mg*h/L) Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of; DOSE=Exposure comparisons and internal dosimetry predictions Internal Dose Metric External dose AUC (mg*h/L) Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/childre...; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 100 Table 8: Exposure comparisons and internal dosimetry predictions Internal Dose Metric External dose AUC (mg*h/L) Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Exposure comparisons and internal dosimetry predictions Internal Dose Metric External dose AUC (mg*h/L) Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/childre...","duration":"","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 100 Table 8: Exposure comparisons and internal dosimetry predictions Internal Dose Metric External dose AUC (mg*h/L) Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 100 Table 8: Exposure comparisons and internal dosimetry predictions Internal Dose Metric External dose AUC (mg*h/L) Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of","page":100,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_067"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
369 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.; DOSE=Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Inf...; EFFECT=Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Inf...","duration":"","effect":"Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Subpopulation Description mg/kg/day BW PhE PhAA Rat NOAEL (drinking water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.","page":100,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_068"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
369 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:ing water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infa; DOSE=Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/...; EFFECT=ing water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/...","duration":"","effect":"ing water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infa","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:ing water) 369 0.25 61.5 690 Adult Human Aggregate (oral+dermal exposure to cosmetics) 2.34 60 0.924 9.09 Infant/children Part 1 (Daily Baby Care) 1.46 8 0.171 2.86 Infant/children Part 2a (Leave-on/nappy) 2.64 8 0.789 13.3 Infant/children Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infa","page":100,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_069"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infant/Children Total (1+2a+2b) 6.1 1.56 39; DOSE=Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/...; EFFECT=Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infant/Children Total (1+2a+2b) 6.1 1.56 39; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/...","duration":"","effect":"Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infant/Children Total (1+2a+2b) 6.1 1.56 39","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Part 2b (wipes/nappy) 2.00 8 0.598 10.0 Infant/children Parts 1+2a+2b 6.1 8 1.56 26.2 Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child Rat External Oral Dose of PhE at NOAEL (mg/kg/day) Rat PBPK model Rat Internal dose of PhE at NOAEL (AUC=mg*hr/L) RAT 369 61.5 HUMAN Subpopulation Exposure Scenario Consumer exposure (mg/kg/day) Human PBPK model Internal dose from consumer exposure (AUC=mg*hr/L) MoS based on internal dose (Rat internal dose at NOAEL/ Human internal dose from consumer exposure) Adult Aggregate (oral+dermal exposure to cosmetics) 2.34 0.924 67 Infant/Children Part 1 (Daily Baby Care) 1.46 0.171 359 Infant/Children Part 2a (Leave- on/nappy) 2.64 0.789 78 Infant/Children Part 2b (Wipes/nappy) 2.00 0.598 103 Infant/Children Total (1+2a+2b) 6.1 1.56 39","page":100,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_070"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
5 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Table 5: the NOAEL rang | e. The assay | achiev | ed the LLOQ of 10 | and 20 | ng/mL of P | E and PAA,; EFFECT=Table 5: the NOAEL rang | e. The assay | achiev | ed the LLOQ of 10 | and 20 | ng/mL of P | E and PAA,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 5: the NOAEL rang | e. The assay | achiev | ed the LLOQ of 10 | and 20 | ng/mL of P | E and PAA,","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Table 5: the NOAEL rang | e. The assay | achiev | ed the LLOQ of 10 | and 20 | ng/mL of P | E and PAA,","page":57,"route":"","species":"","study_id":"sccs_o_195_noael_071"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
4.5 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=4.5, and 5.0 fo; EFFECT=Table 5: 4.5, and 5.0 fo | r the intraven | ous d | oses of 0.2, 0.5 | and 2 m | g/kg, respe | ctively. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 5: 4.5, and 5.0 fo | r the intraven | ous d | oses of 0.2, 0.5 | and 2 m | g/kg, respe | ctively. The","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"4.5, and 5.0 fo","page":57,"route":"","species":"","study_id":"sccs_o_195_noael_072"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
10 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=10–11min). Thes; EFFECT=Table 5: 10–11min). Thes | e values remai | ned u | naltered as a functi | on of the | injected do | se range of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 5: 10–11min). Thes | e values remai | ned u | naltered as a functi | on of the | injected do | se range of","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"10–11min). Thes","page":57,"route":"","species":"","study_id":"sccs_o_195_noael_073"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2 |
mg/kg |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=2; DOSE=0.2–2 mg/kg, in | dicating dose-li | near | kinetics.; EFFECT=Table 5: 0.2–2 mg/kg, in | dicating dose-li | near | kinetics. Immediatel | y after in | jection of P | E, PAA was; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"0.2–2 mg/kg, in | dicating dose-li | near | kinetics.","duration":"","effect":"Table 5: 0.2–2 mg/kg, in | dicating dose-li | near | kinetics. Immediatel | y after in | jection of P | E, PAA was","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg","noael_value":"2","page":57,"route":"","species":"","study_id":"sccs_o_195_noael_074"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
7 |
% |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=7; DOSE=Table 5: extensively excre | ted in urine (64 | .7–75 | .7% of the equivale | nt dose of | PE).; EFFECT=Table 5: extensively excre | ted in urine (64 | .7–75 | .7% of the equivale | nt dose of | PE).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Table 5: extensively excre | ted in urine (64 | .7–75 | .7% of the equivale | nt dose of | PE).","duration":"","effect":"Table 5: extensively excre | ted in urine (64 | .7–75 | .7% of the equivale | nt dose of | PE).","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"7","page":57,"route":"","species":"","study_id":"sccs_o_195_noael_075"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
61 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 61: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690 | - | -; EFFECT=Unlabeled table on page 61: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690 | - | -; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 61: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690 | - | -","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 61: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690 | - | -","page":61,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_076"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
- |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Daily Baby Care (Part 1) a; EFFECT=Unlabeled table on page 61: Human (infant) | Daily Baby Care (Part 1) a | 1.72 | 8 | 0.279 | 3.19 | 220 | 217; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 61: Human (infant) | Daily Baby Care (Part 1) a | 1.72 | 8 | 0.279 | 3.19 | 220 | 217","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Daily Baby Care (Part 1) a","page":61,"route":"","species":"human","study_id":"sccs_o_195_noael_077"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2 |
- |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Part 2a (Leave-on/nappy); EFFECT=Unlabeled table on page 61: Human (infant) | Part 2a (Leave-on/nappy) | 2.64 | 8 | 1.04 | 12.0 | 59 | 58; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 61: Human (infant) | Part 2a (Leave-on/nappy) | 2.64 | 8 | 1.04 | 12.0 | 59 | 58","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Part 2a (Leave-on/nappy)","page":61,"route":"","species":"human","study_id":"sccs_o_195_noael_078"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2 |
- |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Part 2b (wipes/nappy); EFFECT=Unlabeled table on page 61: Human (infant) | Part 2b (wipes/nappy) | 2.00 | 8 | 0.97 | 11.1 | 63 | 62; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 61: Human (infant) | Part 2b (wipes/nappy) | 2.00 | 8 | 0.97 | 11.1 | 63 | 62","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Part 2b (wipes/nappy)","page":61,"route":"","species":"human","study_id":"sccs_o_195_noael_079"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
- |
human |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Parts 1+2a+2b; EFFECT=Unlabeled table on page 61: Human (infant) | Parts 1+2a+2b | 6.36 | 8 | 2.29 | 26.3 | 27 | 26; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 61: Human (infant) | Parts 1+2a+2b | 6.36 | 8 | 2.29 | 26.3 | 27 | 26","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Parts 1+2a+2b","page":61,"route":"","species":"human","study_id":"sccs_o_195_noael_080"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
13 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Table 13: Dow New Zealand White | Only local | NOAEL: | Dose range finding; DOSE=Dow New Zealand White | Only local | NOAEL: | Dose range finding; EFFECT=Table 13: Dow New Zealand White | Only local | NOAEL: | Dose range finding; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Dow New Zealand White | Only local | NOAEL: | Dose range finding","duration":"","effect":"Table 13: Dow New Zealand White | Only local | NOAEL: | Dose range finding","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: Dow New Zealand White | Only local | NOAEL: | Dose range finding","page":74,"route":"","species":"","study_id":"sccs_o_195_noael_081"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
13 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Table 13: 1984, occlusive (24 h/day); | and weight loss | (NOAEL | per dose group; DOSE=1984, occlusive (24 h/day); | and weight loss | (NOAEL | per dose group; EFFECT=Table 13: 1984, occlusive (24 h/day); | and weight loss | (NOAEL | per dose group; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"1984, occlusive (24 h/day); | and weight loss | (NOAEL | per dose group","duration":"","effect":"Table 13: 1984, occlusive (24 h/day); | and weight loss | (NOAEL | per dose group","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: 1984, occlusive (24 h/day); | and weight loss | (NOAEL | per dose group","page":74,"route":"","species":"","study_id":"sccs_o_195_noael_082"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
13 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Table 13: Scortichini et New Zealand White | Haematotoxicity, | NOAEL: | Published report; EFFECT=Table 13: Scortichini et New Zealand White | Haematotoxicity, | NOAEL: | Published report; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 13: Scortichini et New Zealand White | Haematotoxicity, | NOAEL: | Published report","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: Scortichini et New Zealand White | Haematotoxicity, | NOAEL: | Published report","page":74,"route":"","species":"","study_id":"sccs_o_195_noael_083"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
13 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Table 13: (ref 18) occlusive (24 h/day); | dams at 600 and | (NOAEL; EFFECT=Table 13: (ref 18) occlusive (24 h/day); | dams at 600 and | (NOAEL; CITATION=(ref 18); CITATION_NUMBERS=[18]; REFERENCE=(ref 18); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref 18)","dose":"","duration":"","effect":"Table 13: (ref 18) occlusive (24 h/day); | dams at 600 and | (NOAEL","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: (ref 18) occlusive (24 h/day); | dams at 600 and | (NOAEL","page":74,"route":"","species":"","study_id":"sccs_o_195_noael_084"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
13 |
- |
rabbit |
dermal |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Table 13: Dow Rabbit, dermal, 90 | Only local | NOAEL: 500 | GLP study, equivalent; EFFECT=Table 13: Dow Rabbit, dermal, 90 | Only local | NOAEL: 500 | GLP study, equivalent; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 13: Dow Rabbit, dermal, 90 | Only local | NOAEL: 500 | GLP study, equivalent","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Table 13: Dow Rabbit, dermal, 90 | Only local | NOAEL: 500 | GLP study, equivalent","page":74,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_085"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=0, 100, 300 and 1000 mg/kg bw/day | T-Bilirubin, total proteins ↓;; EFFECT=Unlabeled table on page 75: BASF AG, 2006, (ref. 16) | Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day | T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) | NOAEL: 300 (NOAEL offspring: 1000) | GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters; CITATION=(ref. 16); CITATION_NUMBERS=[16]; REFERENCE=(ref. 16); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 16)","dose":"0, 100, 300 and 1000 mg/kg bw/day | T-Bilirubin, total proteins ↓;","duration":"","effect":"Unlabeled table on page 75: BASF AG, 2006, (ref. 16) | Wistar rat, oral, gavage, days 6 - 19 of gestation. 0, 100, 300 and 1000 mg/kg bw/day | T-Bilirubin, total proteins ↓; Triglycerides ↑; (no haemato- toxicity) | NOAEL: 300 (NOAEL offspring: 1000) | GLP study, OECD 414. Additionally: clinical chemistry and haematotoxicity parameters","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_086"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 75: Bayer AG, 2002 (ref. 10) | Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. | NOAEL: 697 (males) | GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable; EFFECT=Unlabeled table on page 75: Bayer AG, 2002 (ref. 10) | Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. | NOAEL: 697 (males) | GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable; CITATION=(ref. 10); CITATION_NUMBERS=[10]; REFERENCE=(ref. 10); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 10)","dose":"","duration":"90 days","effect":"Unlabeled table on page 75: Bayer AG, 2002 (ref. 10) | Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. | NOAEL: 697 (males) | GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: Bayer AG, 2002 (ref. 10) | Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. | NOAEL: 697 (males) | GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_087"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
164 |
mg/kg bw/day |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=164; DOSE=Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day | NOAEL:; EFFECT=Unlabeled table on page 75: Unilever, 1993 (ref. 11) | Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 | Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day | NOAEL: 164 | Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable; CITATION=(ref. 11); CITATION_NUMBERS=[11]; REFERENCE=(ref. 11); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 11)","dose":"Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day | NOAEL:","duration":"90 days","effect":"Unlabeled table on page 75: Unilever, 1993 (ref. 11) | Wistar rat, oral, 90 days, diet. Doses M+F combined: 0, 40, 81, 164, 419 | Males: Liver: organ weight and functional parameters reduced at 164 mg/kg bw/day | NOAEL: 164 | Summary report and data tables available. GLP study downgraded to non- GLP for unclear reasons. Study not reliable","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"164","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_088"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 75: NIPA Labs, 1977 (ref. 40) | SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL: 80 | Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable; DOSE=0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL:; EFFECT=Unlabeled table on page 75: NIPA Labs, 1977 (ref. 40) | SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL: 80 | Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable; CITATION=(ref. 40); CITATION_NUMBERS=[40]; REFERENCE=(ref. 40); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 40)","dose":"0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL:","duration":"90 days","effect":"Unlabeled table on page 75: NIPA Labs, 1977 (ref. 40) | SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL: 80 | Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: NIPA Labs, 1977 (ref. 40) | SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL: 80 | Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_089"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.1) | F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 | Haematotoxicity, kidney, bladder | NOAEL: 369 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); EFFECT=Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.1) | F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 | Haematotoxicity, kidney, bladder | NOAEL: 369 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"90 days","effect":"Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.1) | F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 | Haematotoxicity, kidney, bladder | NOAEL: 369 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.1) | F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 | Haematotoxicity, kidney, bladder | NOAEL: 369 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_090"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
- |
mouse |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.2) | B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 | Liver | NOAEL: 390 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); EFFECT=Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.2) | B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 | Liver | NOAEL: 390 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"90 days","effect":"Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.2) | B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 | Liver | NOAEL: 390 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.2) | B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 | Liver | NOAEL: 390 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_091"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
- |
rat |
oral |
2 years |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.3) | F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); DOSE=0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study.; EFFECT=Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.3) | F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study.","duration":"2 years","effect":"Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.3) | F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.3) | F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_092"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
75 |
- |
mouse |
oral |
2 years |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.4) | B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 | Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ | NOAEL: 468 (males) 586 (females) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); EFFECT=Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.4) | B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 | Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ | NOAEL: 468 (males) 586 (females) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"2 years","effect":"Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.4) | B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 | Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ | NOAEL: 468 (males) 586 (females) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.4) | B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 | Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ | NOAEL: 468 (males) 586 (females) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_093"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1000 |
mg/kg bw/day |
rabbit |
oral |
10 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=12 | Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day | Haematotoxicity in all dose groups | LOAEL:; EFFECT=Unlabeled table on page 75: Breslin et al. 1991, Ref. 12 | Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day | Haematotoxicity in all dose groups | LOAEL: 100 | Published report; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"12 | Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day | Haematotoxicity in all dose groups | LOAEL:","duration":"10 days","effect":"Unlabeled table on page 75: Breslin et al. 1991, Ref. 12 | Rabbit, oral, gavage, 10 days, 0, 100, 300, 600, 1000 mg/kg bw/day | Haematotoxicity in all dose groups | LOAEL: 100 | Published report","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":75,"route":"oral","species":"rabbit","study_id":"sccs_o_195_noael_095"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
697 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=NOAEL: 697 (males); EFFECT=Unlabeled table on page 75: Bayer AG, 2002 (ref. 10) | Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. | NOAEL: 697 (males) | GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable; CITATION=(ref. 10); CITATION_NUMBERS=[10]; REFERENCE=(ref. 10); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 10)","dose":"","duration":"90 days","effect":"Unlabeled table on page 75: Bayer AG, 2002 (ref. 10) | Wistar rat, oral, 90 days, diet. Doses of males (M): 0, 34, 169, 697. Doses of females (F): 0, 50, 234, 939. | NOAEL: 697 (males) | GLP study but considerable decrease of body weight, food and water intake in all groups including the control group. Study not reliable","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"NOAEL: 697 (males)","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_096"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
80 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=NOEL: 80; DOSE=0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL:; EFFECT=Unlabeled table on page 75: NIPA Labs, 1977 (ref. 40) | SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL: 80 | Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable; CITATION=(ref. 40); CITATION_NUMBERS=[40]; REFERENCE=(ref. 40); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 40)","dose":"0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL:","duration":"90 days","effect":"Unlabeled table on page 75: NIPA Labs, 1977 (ref. 40) | SD rat, oral, 90 days, gavage. Doses M+F: 0, 80, 400, 2000. | Males: inflammation of kidney at mid dose | NOEL: 80 | Pre-GLP study, several non-treatment related deaths in various dose groups, purity of test substance unknown. Study not reliable","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"NOEL: 80","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_097"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
369 |
- |
rat |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=NOAEL: 369 (males); EFFECT=Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.1) | F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 | Haematotoxicity, kidney, bladder | NOAEL: 369 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"90 days","effect":"Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.1) | F344 rat, oral, 90 days, drinking water. Doses M: 0, 96, 185, 369, 687, 1514; Doses F: 0, 163, 313, 652, 1000, 1702 | Haematotoxicity, kidney, bladder | NOAEL: 369 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"NOAEL: 369 (males)","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_098"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
390 |
- |
mouse |
oral |
90 days |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=NOAEL: 390 (males); EFFECT=Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.2) | B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 | Liver | NOAEL: 390 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"90 days","effect":"Unlabeled table on page 75: MHLW Japan, 2002 (subm. II, ref.2) | B6D2F1 mouse, oral, 90 days, drinking water. Doses M: 0, 182, 390, 765, 1178, 2135 Doses F: 0, 236, 478, 948, 1514, and 2483 | Liver | NOAEL: 390 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"NOAEL: 390 (males)","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_099"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
249 |
- |
rat |
oral |
2 years |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=NOAEL 249 (males); DOSE=0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study.; EFFECT=Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.3) | F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study.","duration":"2 years","effect":"Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.3) | F344 rat, oral, 2 years, drinking water. Doses M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 | Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups | NOAEL 249 (males) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"NOAEL 249 (males)","page":75,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_100"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
468 |
- |
mouse |
oral |
2 years |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=NOAEL: 468 (males) 586 (females); EFFECT=Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.4) | B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 | Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ | NOAEL: 468 (males) 586 (females) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"2 years","effect":"Unlabeled table on page 75: MHLW Japan, 2007 (subm. II, ref.4) | B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 | Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ | NOAEL: 468 (males) 586 (females) | GLP study. Complete study report not available, only summary report and summary appendices (complete data set)","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"NOAEL: 468 (males) 586 (females)","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_101"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
9 |
- |
rat |
oral |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690; EFFECT=Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Rat | NOAEL (drinking water) | 369 | 0.25 | 61.5 | 690","page":100,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_103"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Part 1 (Daily Baby Care); EFFECT=Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Part 1 (Daily Baby Care) | 1.46 | 8 | 0.171 | 2.86; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Part 1 (Daily Baby Care) | 1.46 | 8 | 0.171 | 2.86","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Part 1 (Daily Baby Care)","page":100,"route":"","species":"","study_id":"sccs_o_195_noael_104"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Part 2a (Leave-on/nappy); EFFECT=Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Part 2a (Leave-on/nappy) | 2.64 | 8 | 0.789 | 13.3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Part 2a (Leave-on/nappy) | 2.64 | 8 | 0.789 | 13.3","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Part 2a (Leave-on/nappy)","page":100,"route":"","species":"","study_id":"sccs_o_195_noael_105"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
2 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Part 2b (wipes/nappy); EFFECT=Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Part 2b (wipes/nappy) | 2.00 | 8 | 0.598 | 10.0; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Part 2b (wipes/nappy) | 2.00 | 8 | 0.598 | 10.0","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Part 2b (wipes/nappy)","page":100,"route":"","species":"","study_id":"sccs_o_195_noael_106"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
- |
1 |
- |
- |
- |
- |
- |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=Parts 1+2a+2b; EFFECT=Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Parts 1+2a+2b | 6.1 | 8 | 1.56 | 26.2; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"","duration":"","effect":"Table 9: Margin of Safety calculations for aggregate exposures to adult and 8 kg infant/child: Infant/children | Parts 1+2a+2b | 6.1 | 8 | 1.56 | 26.2","endpoint":"","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"Parts 1+2a+2b","page":100,"route":"","species":"","study_id":"sccs_o_195_noael_107"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
5000 |
ppm |
mouse |
oral |
- |
carcinogenicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=5000; DOSE=study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm.; EFFECT=study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm. No histopathological findings in the kidney were observed in females. While liver enzymes (AST, ALT) were increased in males at 10,000 ppm and increased bilirubin and decreased triglycerides were observed in females at 10,000 ppm, histopathology of the liver was unremarkable in both sexes. Based on the histopathological findings in the kidney in males, the NOAEL is established as 5000 ppm corresponding to 249 mg/kg/day. Subm II, ref. 4 2) Carcinogenicity study in mice MHLW Study, Japan Bioassay Research Center (JBRC), Submission II Guideline: According to OECD guideline no. 451 (1981) Species/strain: Mouse/B6D2F1/Crlj Group size: 50/sex/group Test substance: 2-Phenoxyethanol Batch: PKM4201, PKF5373 Purity: ≥ 99.8% Dose levels: 0, 5000, 10000 and 20000 ppm in drinking water (for dose calculations based on mg/kg bw/day, see below) Vehicle: Drinking water Ro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm.","duration":"","effect":"study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm. No histopathological findings in the kidney were observed in females. While liver enzymes (AST, ALT) were increased in males at 10,000 ppm and increased bilirubin and decreased triglycerides were observed in females at 10,000 ppm, histopathology of the liver was unremarkable in both sexes. Based on the histopathological findings in the kidney in males, the NOAEL is established as 5000 ppm corresponding to 249 mg/kg/day. Subm II, ref. 4 2) Carcinogenicity study in mice MHLW Study, Japan Bioassay Research Center (JBRC), Submission II Guideline: According to OECD guideline no. 451 (1981) Species/strain: Mouse/B6D2F1/Crlj Group size: 50/sex/group Test substance: 2-Phenoxyethanol Batch: PKM4201, PKF5373 Purity: ≥ 99.8% Dose levels: 0, 5000, 10000 and 20000 ppm in drinking water (for dose calculations based on mg/kg bw/day, see below) Vehicle: Drinking water Ro","endpoint":"carcinogenicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":38,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
10000 |
ppm |
rat |
oral |
90-day |
carcinogenicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=10,000; DOSE=In the 90-day study in rats, the dose levels were 0, 1250, 2500, 5000, 10,000 and 20,000 ppm in drinking water; in the corresponding carcinogenicity study in rats, dose levels of 0, 2500, 5000, and 10,000 ppm were used.; EFFECT=tables, two 90-day studies and two carcinogenicity studies (subm II, ref. 1, 2, 3 and 4). In the 90-day study in rats, the dose levels were 0, 1250, 2500, 5000, 10,000 and 20,000 ppm in drinking water; in the corresponding carcinogenicity study in rats, dose levels of 0, 2500, 5000, and 10,000 ppm were used. In the 90-day study, the critical effects in this study are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥10,000 ppm. The NOAEL is considered to be 5000 ppm corresponding to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"In the 90-day study in rats, the dose levels were 0, 1250, 2500, 5000, 10,000 and 20,000 ppm in drinking water; in the corresponding carcinogenicity study in rats, dose levels of 0, 2500, 5000, and 10,000 ppm were used.","duration":"90-day","effect":"tables, two 90-day studies and two carcinogenicity studies (subm II, ref. 1, 2, 3 and 4). In the 90-day study in rats, the dose levels were 0, 1250, 2500, 5000, 10,000 and 20,000 ppm in drinking water; in the corresponding carcinogenicity study in rats, dose levels of 0, 2500, 5000, and 10,000 ppm were used. In the 90-day study, the critical effects in this study are the effects on red blood cell parameters and the histopathological changes in the kidney and urinary bladder which occurred at doses ≥10,000 ppm. The NOAEL is considered to be 5000 ppm corresponding to","endpoint":"carcinogenicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"10,000","page":77,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_054"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
5000 |
ppm |
rat |
oral |
90-day |
carcinogenicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=5000; DOSE=The kidney was a target organ in males in this study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm.; EFFECT=ogenicity study, there was no evidence of carcinogenic activity of 2- phenoxyethanol in male or female rats and there were no clear treatment-related haematological effects. The kidney was a target organ in males in this study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm. No histopathological findings in the kidney were observed in females. Based on the histopathological findings in the kidney in males, the NOAEL is established as 5000 ppm corresponding to 249 mg/kg/day. In the 90-day study in mice, the dose levels were 0, 1250, 2500, 5000, 10,000 and 20,000 ppm in drinking water, in the corresponding carcinogenicity study in mice, dose levels of 0, 5000, 10,000 and 20,000 ppm were used. Changes in red blood cell parameters in females (haemoglobin, MCHC, and MCV) and males (reticulocytes) at 20,000 ppm suggest a slight haemolytic anaemia at the high dose but no effect at lower doses. Changes in clinical chemistry paramete; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"The kidney was a target organ in males in this study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm.","duration":"90-day","effect":"ogenicity study, there was no evidence of carcinogenic activity of 2- phenoxyethanol in male or female rats and there were no clear treatment-related haematological effects. The kidney was a target organ in males in this study with an increased incidence of slight to moderate urothelial hyperplasia and slight papillary mineralisation and necrosis observed in males at 10,000 ppm. No histopathological findings in the kidney were observed in females. Based on the histopathological findings in the kidney in males, the NOAEL is established as 5000 ppm corresponding to 249 mg/kg/day. In the 90-day study in mice, the dose levels were 0, 1250, 2500, 5000, 10,000 and 20,000 ppm in drinking water, in the corresponding carcinogenicity study in mice, dose levels of 0, 5000, 10,000 and 20,000 ppm were used. Changes in red blood cell parameters in females (haemoglobin, MCHC, and MCV) and males (reticulocytes) at 20,000 ppm suggest a slight haemolytic anaemia at the high dose but no effect at lower doses. Changes in clinical chemistry paramete","endpoint":"carcinogenicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":78,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_055"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
carcinogenicity |
2500 |
ppm |
mouse |
oral |
13-week |
carcinogenicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=2500; DOSE=st a treatment- related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT).; EFFECT=st a treatment- related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT). Relative increases of kidney weight occurred in both sexes at higher dose levels (≥10,000 ppm). While it is possible that the liver-related changes in cholesterol and phospholipid are not adverse, these findings in males are conservatively used as the basis for establishing the NOAEL in this study at 2500 ppm, corresponding to an intake of 390 mg/kg/day. In the carcinogenicity study, also conducted in drinking water, there was no evidence of carcinogenic activity of 2-phenoxyethanol in male or female mice. There was no evidence of any histopathology in the liver and no increase in liver enzymes (ALT, AST). However, similar effects on cholesterol and phospholipids were observed in the 13-week drinking water study in the same strain of mice. Therefore, these findings in males in the chronic stud; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"st a treatment- related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT).","duration":"13-week","effect":"st a treatment- related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT). Relative increases of kidney weight occurred in both sexes at higher dose levels (≥10,000 ppm). While it is possible that the liver-related changes in cholesterol and phospholipid are not adverse, these findings in males are conservatively used as the basis for establishing the NOAEL in this study at 2500 ppm, corresponding to an intake of 390 mg/kg/day. In the carcinogenicity study, also conducted in drinking water, there was no evidence of carcinogenic activity of 2-phenoxyethanol in male or female mice. There was no evidence of any histopathology in the liver and no increase in liver enzymes (ALT, AST). However, similar effects on cholesterol and phospholipids were observed in the 13-week drinking water study in the same strain of mice. Therefore, these findings in males in the chronic stud","endpoint":"carcinogenicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"2500","page":78,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_056"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
rabbit |
- |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=The external and soft tissue and/or skeletal examinations of the foetuses revealed no toxicologically relevant differences between the control and the treated groups.; EFFECT=ated differences were recorded for placental and foetal body weights. The external and soft tissue and/or skeletal examinations of the foetuses revealed no toxicologically relevant differences between the control and the treated groups. The number and type of foetal external, soft tissue and skeletal findings, which were classified as malformations and/or variations, did not show differences of toxicological relevance among the groups. Conclusion Based on the effects in the dams observed at 1000 mg/kg bw/day, the NOAEL (no- observed adverse-effect level) for maternal toxicity was considered to be 300 mg/kg bw/day. 2-Phenoxyethanol had no effect on gestational parameters and induced no signs of developmental toxicity up to and including the high dose of 1000 mg/kg bw/day. Therefore, the NOAEL (no observed effect level) for developmental toxicity was considered to be 1000 mg/kg bw/day. Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test su; CITATION=Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test su; CITATION_NUMBERS=[16,2,10]; REFERENCE=Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test su; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test su","dose":"The external and soft tissue and/or skeletal examinations of the foetuses revealed no toxicologically relevant differences between the control and the treated groups.","duration":"developmental","effect":"ated differences were recorded for placental and foetal body weights. The external and soft tissue and/or skeletal examinations of the foetuses revealed no toxicologically relevant differences between the control and the treated groups. The number and type of foetal external, soft tissue and skeletal findings, which were classified as malformations and/or variations, did not show differences of toxicological relevance among the groups. Conclusion Based on the effects in the dams observed at 1000 mg/kg bw/day, the NOAEL (no- observed adverse-effect level) for maternal toxicity was considered to be 300 mg/kg bw/day. 2-Phenoxyethanol had no effect on gestational parameters and induced no signs of developmental toxicity up to and including the high dose of 1000 mg/kg bw/day. Therefore, the NOAEL (no observed effect level) for developmental toxicity was considered to be 1000 mg/kg bw/day. Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test su","endpoint":"developmental toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":44,"route":"","species":"rabbit","study_id":"sccs_o_195_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
rabbit |
dermal |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=Conclusion Based on the effects in the dams observed at 1000 mg/kg bw/day, the NOAEL (no- observed adverse-effect level) for maternal toxicity was considered to be 300 mg/kg bw/day.; EFFECT=oft tissue and skeletal findings, which were classified as malformations and/or variations, did not show differences of toxicological relevance among the groups. Conclusion Based on the effects in the dams observed at 1000 mg/kg bw/day, the NOAEL (no- observed adverse-effect level) for maternal toxicity was considered to be 300 mg/kg bw/day. 2-Phenoxyethanol had no effect on gestational parameters and induced no signs of developmental toxicity up to and including the high dose of 1000 mg/kg bw/day. Therefore, the NOAEL (no observed effect level) for developmental toxicity was considered to be 1000 mg/kg bw/day. Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test substance: 2-Phenoxyethanol Batch No.: 53 (C44172) Purity: 99.9% Dose level: 0, 300, 600 and 1000 mg/kg bw/day Route: Dermal, occlusive conditions (24 hours/day throughout the treatment period) Vehicle: Undiluted Dosing schedule: Days 6 through 18 of gestation GLP:; CITATION=Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test substance: 2-Phenoxyethanol Batch No; CITATION_NUMBERS=[16,2,10]; REFERENCE=Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test substance: 2-Phenoxyethanol Batch No; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test substance: 2-Phenoxyethanol Batch No","dose":"Conclusion Based on the effects in the dams observed at 1000 mg/kg bw/day, the NOAEL (no- observed adverse-effect level) for maternal toxicity was considered to be 300 mg/kg bw/day.","duration":"developmental","effect":"oft tissue and skeletal findings, which were classified as malformations and/or variations, did not show differences of toxicological relevance among the groups. Conclusion Based on the effects in the dams observed at 1000 mg/kg bw/day, the NOAEL (no- observed adverse-effect level) for maternal toxicity was considered to be 300 mg/kg bw/day. 2-Phenoxyethanol had no effect on gestational parameters and induced no signs of developmental toxicity up to and including the high dose of 1000 mg/kg bw/day. Therefore, the NOAEL (no observed effect level) for developmental toxicity was considered to be 1000 mg/kg bw/day. Ref.: 16 Study No 2 in rabbits (dose-range finding study) Guideline: / Species/strain: Rabbit/New Zealand White Group size: 10 females Test substance: 2-Phenoxyethanol Batch No.: 53 (C44172) Purity: 99.9% Dose level: 0, 300, 600 and 1000 mg/kg bw/day Route: Dermal, occlusive conditions (24 hours/day throughout the treatment period) Vehicle: Undiluted Dosing schedule: Days 6 through 18 of gestation GLP:","endpoint":"developmental toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":44,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
1000 |
mg/kg bw/day |
- |
dermal |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=Foetuses from the 5 animals treated with 1000 mg/kg bw/day that survived to day 28 also did not exhibit external, visceral or skeletal alterations (no statistical evaluations were performed on these data).; EFFECT=exhibited oligodactyly. Foetuses from the 5 animals treated with 1000 mg/kg bw/day that survived to day 28 also did not exhibit external, visceral or skeletal alterations (no statistical evaluations were performed on these data). Conclusion Dermal application of 2-phenoxyethanol produced no evidence of teratogenicity, fetotoxicity or embryotoxicity under the conditions of this study. Maternal toxicity, including dose- related intravascular haemolysis, was observed in dams dosed with 600 and 1000 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 300 mg/kg bw/day. The NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day because maternal deaths at 1000 mg/kg bw/day precluded a full evaluation of developmental toxicity in the highest dose group. Ref.: 18; CITATION=Ref.: 18; CITATION_NUMBERS=[18]; REFERENCE=Ref.: 18; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 18","dose":"Foetuses from the 5 animals treated with 1000 mg/kg bw/day that survived to day 28 also did not exhibit external, visceral or skeletal alterations (no statistical evaluations were performed on these data).","duration":"developmental","effect":"exhibited oligodactyly. Foetuses from the 5 animals treated with 1000 mg/kg bw/day that survived to day 28 also did not exhibit external, visceral or skeletal alterations (no statistical evaluations were performed on these data). Conclusion Dermal application of 2-phenoxyethanol produced no evidence of teratogenicity, fetotoxicity or embryotoxicity under the conditions of this study. Maternal toxicity, including dose- related intravascular haemolysis, was observed in dams dosed with 600 and 1000 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 300 mg/kg bw/day. The NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day because maternal deaths at 1000 mg/kg bw/day precluded a full evaluation of developmental toxicity in the highest dose group. Ref.: 18","endpoint":"developmental toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":46,"route":"dermal","species":"","study_id":"sccs_o_195_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/day |
- |
dermal |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=300; DOSE=Maternal toxicity, including dose- related intravascular haemolysis, was observed in dams dosed with 600 and 1000 mg/kg bw/day.; EFFECT=g/kg bw/day that survived to day 28 also did not exhibit external, visceral or skeletal alterations (no statistical evaluations were performed on these data). Conclusion Dermal application of 2-phenoxyethanol produced no evidence of teratogenicity, fetotoxicity or embryotoxicity under the conditions of this study. Maternal toxicity, including dose- related intravascular haemolysis, was observed in dams dosed with 600 and 1000 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 300 mg/kg bw/day. The NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day because maternal deaths at 1000 mg/kg bw/day precluded a full evaluation of developmental toxicity in the highest dose group. Ref.: 18; CITATION=Ref.: 18; CITATION_NUMBERS=[18]; REFERENCE=Ref.: 18; DETAILS_JSON={"cas_number":"122-99-6","citation":"Ref.: 18","dose":"Maternal toxicity, including dose- related intravascular haemolysis, was observed in dams dosed with 600 and 1000 mg/kg bw/day.","duration":"developmental","effect":"g/kg bw/day that survived to day 28 also did not exhibit external, visceral or skeletal alterations (no statistical evaluations were performed on these data). Conclusion Dermal application of 2-phenoxyethanol produced no evidence of teratogenicity, fetotoxicity or embryotoxicity under the conditions of this study. Maternal toxicity, including dose- related intravascular haemolysis, was observed in dams dosed with 600 and 1000 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 300 mg/kg bw/day. The NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day because maternal deaths at 1000 mg/kg bw/day precluded a full evaluation of developmental toxicity in the highest dose group. Ref.: 18","endpoint":"developmental toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":46,"route":"dermal","species":"","study_id":"sccs_o_195_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/day |
rabbit |
dermal |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=300; DOSE=0, 300, 600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref.; EFFECT=in rabbits (days 6 – 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref. 17). In the developmental toxicity study at the same dosing schedule, however, deaths obviously due to haematoxicity were observed: 9 dead or moribund animals at 1000 mg/kg bw/day, 5 at 600 mg/kg bw/day, and no deaths at 300 mg/kg bw/day. Most deaths occurred between gestation days 11 and 18 (6 to 13 doses). No signs of maternal toxicity were seen at the low dose so that the maternal NOAEL of this study is 300 mg/kg bw/day (the NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day) (ref. 18). The study report of the original main study (AR 6) was not provided; only a published report is available (ref. 18). Breslin et al. (1991, ref. 12), the authors of the 90-day dermal toxicity study in rabbits (see below), reported that according to their experience from additional pilot studies conducted with non-pregnant rabbits at dermal doses of 1000 mg/kg bw/day for 14 days, the susceptibilit; CITATION=(ref. 17); CITATION_NUMBERS=[17]; REFERENCE=(ref. 17); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 17)","dose":"0, 300, 600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref.","duration":"developmental","effect":"in rabbits (days 6 – 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref. 17). In the developmental toxicity study at the same dosing schedule, however, deaths obviously due to haematoxicity were observed: 9 dead or moribund animals at 1000 mg/kg bw/day, 5 at 600 mg/kg bw/day, and no deaths at 300 mg/kg bw/day. Most deaths occurred between gestation days 11 and 18 (6 to 13 doses). No signs of maternal toxicity were seen at the low dose so that the maternal NOAEL of this study is 300 mg/kg bw/day (the NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day) (ref. 18). The study report of the original main study (AR 6) was not provided; only a published report is available (ref. 18). Breslin et al. (1991, ref. 12), the authors of the 90-day dermal toxicity study in rabbits (see below), reported that according to their experience from additional pilot studies conducted with non-pregnant rabbits at dermal doses of 1000 mg/kg bw/day for 14 days, the susceptibilit","endpoint":"developmental toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":76,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_049"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
developmental toxicity |
300 |
mg/kg bw/day |
rabbit |
dermal |
developmental |
developmental toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=300; DOSE=600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref.; EFFECT=600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref. 17). In the developmental toxicity study at the same dosing schedule, however, deaths obviously due to haematoxicity were observed: 9 dead or moribund animals at 1000 mg/kg bw/day, 5 at 600 mg/kg bw/day, and no deaths at 300 mg/kg bw/day. Most deaths occurred between gestation days 11 and 18 (6 to 13 doses). No signs of maternal toxicity were seen at the low dose so that the maternal NOAEL of this study is 300 mg/kg bw/day (the NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day) (ref. 18). The study report of the original main study (AR 6) was not provided; only a published report is available (ref. 18). Breslin et al. (1991, ref. 12), the authors of the 90-day dermal toxicity study in rabbits (see below), reported that according to their experience from additional pilot studies conducted with non-pregnant rabbits at dermal doses of 1000 mg/kg bw/day for 14 days, the susceptibility of individual rabbits to the haemolytic eff; CITATION=(ref. 17); CITATION_NUMBERS=[17]; REFERENCE=(ref. 17); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 17)","dose":"600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref.","duration":"developmental","effect":"600 and 1000 mg/kg bw/day), no systemic effects occurred up to 1000 mg/kg bw/day (ref. 17). In the developmental toxicity study at the same dosing schedule, however, deaths obviously due to haematoxicity were observed: 9 dead or moribund animals at 1000 mg/kg bw/day, 5 at 600 mg/kg bw/day, and no deaths at 300 mg/kg bw/day. Most deaths occurred between gestation days 11 and 18 (6 to 13 doses). No signs of maternal toxicity were seen at the low dose so that the maternal NOAEL of this study is 300 mg/kg bw/day (the NOAEL for developmental toxicity was concluded to be 600 mg/kg bw/day) (ref. 18). The study report of the original main study (AR 6) was not provided; only a published report is available (ref. 18). Breslin et al. (1991, ref. 12), the authors of the 90-day dermal toxicity study in rabbits (see below), reported that according to their experience from additional pilot studies conducted with non-pregnant rabbits at dermal doses of 1000 mg/kg bw/day for 14 days, the susceptibility of individual rabbits to the haemolytic eff","endpoint":"developmental toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":76,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_050"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
357 |
mg/kg bw/day |
- |
- |
Chronic |
genotoxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=357; DOSE=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 29 To account for the dosing schedule used in this study, the NOAEL should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day.; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 29 To account for the dosing schedule used in this study, the NOAEL should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day. Table 3 3.3.5.5 Chronic (> 12 months) toxicity See 3.3.7. 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation test Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, and E. coli WP2 uvr A Replicates: Triplicates were investigated per test concentration Treatment: Plate incorporation and pre-incubation test without and with S9 mix fr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 29 To account for the dosing schedule used in this study, the NOAEL should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day.","duration":"Chronic","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 29 To account for the dosing schedule used in this study, the NOAEL should be multiplied by a factor of 5/7 to give an adjusted NOAEL of 357 mg/kg bw/day. Table 3 3.3.5.5 Chronic (> 12 months) toxicity See 3.3.7. 3.3.6 Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation test Guideline: OECD 471 (1997) Species/strain: S. typhimurium, TA98, TA100, TA1535, TA1537, and E. coli WP2 uvr A Replicates: Triplicates were investigated per test concentration Treatment: Plate incorporation and pre-incubation test without and with S9 mix fr","endpoint":"genotoxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"357","page":29,"route":"","species":"","study_id":"sccs_o_195_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
genotoxicity |
357 |
mg/kg bw/day |
- |
- |
- |
genotoxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=357; DOSE=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 79 with an adjusted NOAEL of 357 mg/kg bw/day is used as the key study for the MoS calculation.; EFFECT=SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 79 with an adjusted NOAEL of 357 mg/kg bw/day is used as the key study for the MoS calculation. Mutagenicity 2-Phenoxyethanol was tested for mutagenic/genotoxic potential in an adequate battery of in vitro and in vivo tests with various endpoints. 2-Phenoxyethanol was not mutagenic in the Ames test at concentrations up to 5000 μg/plate with and without metabolic activation. Further tests for gene mutation at the Hprt locus in mammalian cells also showed no evidence of mutagenic potential either with or without metabolic activation. In vit; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 79 with an adjusted NOAEL of 357 mg/kg bw/day is used as the key study for the MoS calculation.","duration":"","effect":"SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 79 with an adjusted NOAEL of 357 mg/kg bw/day is used as the key study for the MoS calculation. Mutagenicity 2-Phenoxyethanol was tested for mutagenic/genotoxic potential in an adequate battery of in vitro and in vivo tests with various endpoints. 2-Phenoxyethanol was not mutagenic in the Ames test at concentrations up to 5000 μg/plate with and without metabolic activation. Further tests for gene mutation at the Hprt locus in mammalian cells also showed no evidence of mutagenic potential either with or without metabolic activation. In vit","endpoint":"genotoxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"357","page":79,"route":"","species":"","study_id":"sccs_o_195_noael_058"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
2 |
- |
rat |
inhalation |
5 days |
irritation |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:e: Five per sex per dose Test substance: 2-phenoxyethanol Batch: 41183068E0 Purity: > 99.9 core peak-area% (GC) Dose level: 0, 40, 200, 1000 mg/m³ (nominal) Vehicle: air Dose route: Inhalation, nose/head only Dosing schedule: 6 hours per day, 5 days per week for 2 weeks (10 exposures) Observation period: 14 days GLP: Yes Study period: 06 Sep 2005 - 17 Feb 2007 Report date: 2007 This study was conducted to characterise the toxicity profile of 2-phenoxyethanol including target organs and to determine a NOAEL after 2-weeks exposure to liquid aerosols. Special emphasis was given to potential irritation effects in the respiratory tract. A total of 10 Wistar rats (5 males and 5 females) per test group were head-nose exposed to liquid aerosols for 6 hours per day, 5 days per week for 14 days (10 exposures). The target concentrations were 40, 200, and 1000 mg/m³. The mean measured concentrations were 48.2, 246, and 1070 mg/m³. A concurrent control group was exposed to conditioned air. On exposure days, the clinical examinat; DOSE=Five per sex per dose Test substance:; EFFECT=e: Five per sex per dose Test substance: 2-phenoxyethanol Batch: 41183068E0 Purity: > 99.9 core peak-area% (GC) Dose level: 0, 40, 200, 1000 mg/m³ (nominal) Vehicle: air Dose route: Inhalation, nose/head only Dosing schedule: 6 hours per day, 5 days per week for 2 weeks (10 exposures) Observation period: 14 days GLP: Yes Study period: 06 Sep 2005 - 17 Feb 2007 Report date: 2007 This study was conducted to characterise the toxicity profile of 2-phenoxyethanol including target organs and to determine a NOAEL after 2-weeks exposure to liquid aerosols. Special emphasis was given to potential irritation effects in the respiratory tract. A total of 10 Wistar rats (5 males and 5 females) per test group were head-nose exposed to liquid aerosols for 6 hours per day, 5 days per week for 14 days (10 exposures). The target concentrations were 40, 200, and 1000 mg/m³. The mean measured concentrations were 48.2, 246, and 1070 mg/m³. A concurrent control group was exposed to conditioned air. On exposure days, the clinical examinat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Five per sex per dose Test substance:","duration":"5 days","effect":"e: Five per sex per dose Test substance: 2-phenoxyethanol Batch: 41183068E0 Purity: > 99.9 core peak-area% (GC) Dose level: 0, 40, 200, 1000 mg/m³ (nominal) Vehicle: air Dose route: Inhalation, nose/head only Dosing schedule: 6 hours per day, 5 days per week for 2 weeks (10 exposures) Observation period: 14 days GLP: Yes Study period: 06 Sep 2005 - 17 Feb 2007 Report date: 2007 This study was conducted to characterise the toxicity profile of 2-phenoxyethanol including target organs and to determine a NOAEL after 2-weeks exposure to liquid aerosols. Special emphasis was given to potential irritation effects in the respiratory tract. A total of 10 Wistar rats (5 males and 5 females) per test group were head-nose exposed to liquid aerosols for 6 hours per day, 5 days per week for 14 days (10 exposures). The target concentrations were 40, 200, and 1000 mg/m³. The mean measured concentrations were 48.2, 246, and 1070 mg/m³. A concurrent control group was exposed to conditioned air. On exposure days, the clinical examinat","endpoint":"irritation","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:e: Five per sex per dose Test substance: 2-phenoxyethanol Batch: 41183068E0 Purity: > 99.9 core peak-area% (GC) Dose level: 0, 40, 200, 1000 mg/m³ (nominal) Vehicle: air Dose route: Inhalation, nose/head only Dosing schedule: 6 hours per day, 5 days per week for 2 weeks (10 exposures) Observation period: 14 days GLP: Yes Study period: 06 Sep 2005 - 17 Feb 2007 Report date: 2007 This study was conducted to characterise the toxicity profile of 2-phenoxyethanol including target organs and to determine a NOAEL after 2-weeks exposure to liquid aerosols. Special emphasis was given to potential irritation effects in the respiratory tract. A total of 10 Wistar rats (5 males and 5 females) per test group were head-nose exposed to liquid aerosols for 6 hours per day, 5 days per week for 14 days (10 exposures). The target concentrations were 40, 200, and 1000 mg/m³. The mean measured concentrations were 48.2, 246, and 1070 mg/m³. A concurrent control group was exposed to conditioned air. On exposure days, the clinical examinat","page":18,"route":"inhalation","species":"rat","study_id":"sccs_o_195_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
1000 |
mg/kg bw/day |
rat |
dermal |
14 days |
irritation |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=et organs or effects Dose descriptor (mg/kg bw/day) Remarks Inhalation:; EFFECT=et organs or effects Dose descriptor (mg/kg bw/day) Remarks Inhalation: BASF AG, 2007, Ref. 3 Wistar rat, nose only, 14 days; 0, 48.2, 246, and 1070 mg/m3. 6 h/day, 5 days per week Airways: local effects, irritation, increase of lung weight at mid dose NOAEC: 48.2 x 5/7 = 34.4 mg/m3 GLP study, OECD 412 Dermal studies: Dow Chemicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin; CITATION=(ref 17); CITATION_NUMBERS=[17]; REFERENCE=(ref 17); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref 17)","dose":"et organs or effects Dose descriptor (mg/kg bw/day) Remarks Inhalation:","duration":"14 days","effect":"et organs or effects Dose descriptor (mg/kg bw/day) Remarks Inhalation: BASF AG, 2007, Ref. 3 Wistar rat, nose only, 14 days; 0, 48.2, 246, and 1070 mg/m3. 6 h/day, 5 days per week Airways: local effects, irritation, increase of lung weight at mid dose NOAEC: 48.2 x 5/7 = 34.4 mg/m3 GLP study, OECD 412 Dermal studies: Dow Chemicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin","endpoint":"irritation","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":74,"route":"dermal","species":"rat","study_id":"sccs_o_195_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
irritation |
1000 |
mg/kg bw/day |
rat |
dermal |
14 days |
irritation |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=1000; DOSE=effects Dose descriptor (mg/kg bw/day) Remarks Inhalation:; EFFECT=effects Dose descriptor (mg/kg bw/day) Remarks Inhalation: BASF AG, 2007, Ref. 3 Wistar rat, nose only, 14 days; 0, 48.2, 246, and 1070 mg/m3. 6 h/day, 5 days per week Airways: local effects, irritation, increase of lung weight at mid dose NOAEC: 48.2 x 5/7 = 34.4 mg/m3 GLP study, OECD 412 Dermal studies: Dow Chemicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500; CITATION=(ref 17); CITATION_NUMBERS=[17]; REFERENCE=(ref 17); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref 17)","dose":"effects Dose descriptor (mg/kg bw/day) Remarks Inhalation:","duration":"14 days","effect":"effects Dose descriptor (mg/kg bw/day) Remarks Inhalation: BASF AG, 2007, Ref. 3 Wistar rat, nose only, 14 days; 0, 48.2, 246, and 1070 mg/m3. 6 h/day, 5 days per week Airways: local effects, irritation, increase of lung weight at mid dose NOAEC: 48.2 x 5/7 = 34.4 mg/m3 GLP study, OECD 412 Dermal studies: Dow Chemicals, 1984, (ref 17) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Only local effects on skin and weight loss in females NOAEL: 600 (NOAEL offspring: 1000) Dose range finding study with 10 dams per dose group Scortichini et al., 1987, (ref 18) New Zealand White rabbit, dermal, occlusive (24 h/day); days 6 - 18 of gestation; 0, 300, 600 and 1000 mg/kg bw/day Haematotoxicity, 5 deaths of dams at 600 and 9 deaths at 1000 mg/kg bw/day NOAEL: 300 (NOAEL offspring: 600) Published report Dow Chemicals, 1986, (ref. 13); Breslin et al. 1991, (ref. 12) Rabbit, dermal, 90 days. 0, 50, 150, 500 mg/kg bw/day; 5 days per week Only local effects on skin NOAEL: 500","endpoint":"irritation","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":74,"route":"dermal","species":"rat","study_id":"sccs_o_195_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
repeated dose toxicity |
2500 |
ppm |
rabbit |
dermal |
Sub-chronic |
repeated dose toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=2500; DOSE=treatment-related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT).; EFFECT=treatment-related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT). Relative increases of kidney weight occurred in both sexes at higher dose levels (≥ 10000 ppm). While it is possible that the liver-related changes in cholesterol and phospholipid are not adverse, these findings in males were very conservatively used as the basis for establishing the NOAEL in this study at 2500 ppm, corresponding to an intake of 390 mg/kg/day. Subm II, ref. 3 3.3.5.4 Sub-chronic (90 days) toxicity (dermal) Guideline: Equivalent to OECD guideline no. 411 (1981) (see SCCS comment) Species/strain: Rabbit/New Zealand White Group size: 10 per sex per dose Test substance: Ethylene glycol phenyl ether (2-Phenoxyethanol) Batch: 53 (C44172) Purity: 99.9% Dose levels: 0, 50, 150, 500 mg/kg bw/day Vehicle: Undiluted Route: Dermal, occlusive conditions Exposure period: 6 hours per; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"treatment-related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT).","duration":"Sub-chronic","effect":"treatment-related effect on the liver including decreases in cholesterol and phospholipid at doses of > 5,000 ppm in males, although there was no evidence of any histopathology in the liver and no increase in liver enzymes (GPT, GOT). Relative increases of kidney weight occurred in both sexes at higher dose levels (≥ 10000 ppm). While it is possible that the liver-related changes in cholesterol and phospholipid are not adverse, these findings in males were very conservatively used as the basis for establishing the NOAEL in this study at 2500 ppm, corresponding to an intake of 390 mg/kg/day. Subm II, ref. 3 3.3.5.4 Sub-chronic (90 days) toxicity (dermal) Guideline: Equivalent to OECD guideline no. 411 (1981) (see SCCS comment) Species/strain: Rabbit/New Zealand White Group size: 10 per sex per dose Test substance: Ethylene glycol phenyl ether (2-Phenoxyethanol) Batch: 53 (C44172) Purity: 99.9% Dose levels: 0, 50, 150, 500 mg/kg bw/day Vehicle: Undiluted Route: Dermal, occlusive conditions Exposure period: 6 hours per","endpoint":"repeated dose toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"ppm","noael_value":"2500","page":27,"route":"dermal","species":"rabbit","study_id":"sccs_o_195_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2.5 |
% |
mouse |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=2.5; DOSE=Conclusion In this study, fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet.; EFFECT=pups born live, or number of pups per litter. As observed for the F0 pairs, live pup weight (F2 pups) was decreased for the F1 pairs. Conclusion In this study, fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet. The cross-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females. The authors concluded that for male mice (F0) the NOAEL for reproductive toxicity was 2.5% in diet, corresponding to 4000 mg/kg bw/day, and this occurred in the presence of evidence of parental toxicity (decreased body weight and increased liver weight). For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e., 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. The estimated; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Conclusion In this study, fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet.","duration":"","effect":"pups born live, or number of pups per litter. As observed for the F0 pairs, live pup weight (F2 pups) was decreased for the F1 pairs. Conclusion In this study, fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet. The cross-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females. The authors concluded that for male mice (F0) the NOAEL for reproductive toxicity was 2.5% in diet, corresponding to 4000 mg/kg bw/day, and this occurred in the presence of evidence of parental toxicity (decreased body weight and increased liver weight). For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e., 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. The estimated","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"2.5","page":42,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
0.25 |
% |
mouse |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=0.25; DOSE=ignificant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet.; EFFECT=ignificant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet. The cross-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females. The authors concluded that for male mice (F0) the NOAEL for reproductive toxicity was 2.5% in diet, corresponding to 4000 mg/kg bw/day, and this occurred in the presence of evidence of parental toxicity (decreased body weight and increased liver weight). For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e., 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. The estimated; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"ignificant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet.","duration":"","effect":"ignificant toxicity to the offspring was observed when 2-phenoxyethanol was administered at 1.25% and 2.5% in diet. The cross-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females. The authors concluded that for male mice (F0) the NOAEL for reproductive toxicity was 2.5% in diet, corresponding to 4000 mg/kg bw/day, and this occurred in the presence of evidence of parental toxicity (decreased body weight and increased liver weight). For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e., 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. The estimated","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"0.25","page":42,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
400 |
mg/kg bw/day |
mouse |
oral |
- |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=400; DOSE=oss-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females.; EFFECT=oss-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females. The authors concluded that for male mice (F0) the NOAEL for reproductive toxicity was 2.5% in diet, corresponding to 4000 mg/kg bw/day, and this occurred in the presence of evidence of parental toxicity (decreased body weight and increased liver weight). For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e., 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. The estimated; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"oss-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females.","duration":"","effect":"oss-over mating trial suggested a female component to the reproductive toxicity observed in high-dose females. The authors concluded that for male mice (F0) the NOAEL for reproductive toxicity was 2.5% in diet, corresponding to 4000 mg/kg bw/day, and this occurred in the presence of evidence of parental toxicity (decreased body weight and increased liver weight). For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e., 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. The estimated","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":42,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
0 |
- |
mouse |
oral |
2 years |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study; DOSE=0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study.; EFFECT=M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study; CITATION=(ref. 15); CITATION_NUMBERS=[15]; REFERENCE=(ref. 15); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 15)","dose":"0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study.","duration":"2 years","effect":"M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:M: 0, 124, 249, and 510 Doses F: 0, 191, 380, and 795 Histological kidney effects (males) Dose-dependent increases in ovary weights in all dose groups NOAEL 249 (males) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) MHLW Japan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_047"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
2007 |
- |
mouse |
oral |
2 years |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:apan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study; EFFECT=apan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study; CITATION=(ref. 15); CITATION_NUMBERS=[15]; REFERENCE=(ref. 15); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 15)","dose":"","duration":"2 years","effect":"apan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:apan, 2007 (subm. II, ref.4) B6D2F1 mouse, oral, 2 years, drinking water. Doses M: 0, 468, 898, and 1701 Doses F: 0, 586, 1072, 2058 Serum cholesterol ↓, phospholipids, and triglycerides in males ↓; body weight gain in both sexes ↓ NOAEL: 468 (males) 586 (females) GLP study. Complete study report not available, only summary report and summary appendices (complete data set) NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, Liver weight increase NOAEL: 400 (males) 950 (females) GLP study","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_048"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
0.25 |
% |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=0.25; DOSE=Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level.; EFFECT=ons were detected (subm II, ref. 3 and ref. 4). Reproductive toxicity A two-generation reproductive toxicity study in mice with 0, 0.25, 1.25 and 2.5% 2- phenoxyethanol in the diet was conducted according to an NTP protocol. Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level. Parental toxicity was reported at the mid- and high-dose level. For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e. 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. For females, the NOAEL was approximately 950 mg/kg bw/day. Two studies on developmental toxicity are available, one oral rat and one dermal rabbit study. In both studies, the NOAELs for developmental toxicity were higher than the NOAELs for maternal toxicity (300 mg/kg bw/day in both studies). Toxicokinetics 2-Phenoxyethanol is rapidly absorbed, distributed,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level.","duration":"developmental","effect":"ons were detected (subm II, ref. 3 and ref. 4). Reproductive toxicity A two-generation reproductive toxicity study in mice with 0, 0.25, 1.25 and 2.5% 2- phenoxyethanol in the diet was conducted according to an NTP protocol. Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level. Parental toxicity was reported at the mid- and high-dose level. For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e. 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. For females, the NOAEL was approximately 950 mg/kg bw/day. Two studies on developmental toxicity are available, one oral rat and one dermal rabbit study. In both studies, the NOAELs for developmental toxicity were higher than the NOAELs for maternal toxicity (300 mg/kg bw/day in both studies). Toxicokinetics 2-Phenoxyethanol is rapidly absorbed, distributed,","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"%","noael_value":"0.25","page":79,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_059"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
400 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=400; DOSE=Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level.; EFFECT=ce with 0, 0.25, 1.25 and 2.5% 2- phenoxyethanol in the diet was conducted according to an NTP protocol. Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level. Parental toxicity was reported at the mid- and high-dose level. For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e. 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. For females, the NOAEL was approximately 950 mg/kg bw/day. Two studies on developmental toxicity are available, one oral rat and one dermal rabbit study. In both studies, the NOAELs for developmental toxicity were higher than the NOAELs for maternal toxicity (300 mg/kg bw/day in both studies). Toxicokinetics 2-Phenoxyethanol is rapidly absorbed, distributed, metabolised and excreted. More than 90% of the dose recovered was excreted in urine, mainly as 2-phenoxyacetic acid, inde; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level.","duration":"developmental","effect":"ce with 0, 0.25, 1.25 and 2.5% 2- phenoxyethanol in the diet was conducted according to an NTP protocol. Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level. Parental toxicity was reported at the mid- and high-dose level. For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e. 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. For females, the NOAEL was approximately 950 mg/kg bw/day. Two studies on developmental toxicity are available, one oral rat and one dermal rabbit study. In both studies, the NOAELs for developmental toxicity were higher than the NOAELs for maternal toxicity (300 mg/kg bw/day in both studies). Toxicokinetics 2-Phenoxyethanol is rapidly absorbed, distributed, metabolised and excreted. More than 90% of the dose recovered was excreted in urine, mainly as 2-phenoxyacetic acid, inde","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"400","page":79,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_060"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
950 |
mg/kg bw/day |
rat |
oral |
developmental |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=950; DOSE=Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level.; EFFECT=t was conducted according to an NTP protocol. Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level. Parental toxicity was reported at the mid- and high-dose level. For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e. 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. For females, the NOAEL was approximately 950 mg/kg bw/day. Two studies on developmental toxicity are available, one oral rat and one dermal rabbit study. In both studies, the NOAELs for developmental toxicity were higher than the NOAELs for maternal toxicity (300 mg/kg bw/day in both studies). Toxicokinetics 2-Phenoxyethanol is rapidly absorbed, distributed, metabolised and excreted. More than 90% of the dose recovered was excreted in urine, mainly as 2-phenoxyacetic acid, independent of the exposure route (rats, i.v., dermal, oral; hu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"122-99-6","citation":"","dose":"Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level.","duration":"developmental","effect":"t was conducted according to an NTP protocol. Fertility was only minimally affected at the highest dose, but evidence of significant toxicity to the offspring was observed when 2-phenoxyethanol was administered at the mid- and high-dose level. Parental toxicity was reported at the mid- and high-dose level. For both males and females, the NOAEL for parental toxicity and reproductive toxicity was concluded to be the low dose, i.e. 0.25% in diet. For males, a NOAEL of 400 mg/kg bw/day was calculated. For females, the NOAEL was approximately 950 mg/kg bw/day. Two studies on developmental toxicity are available, one oral rat and one dermal rabbit study. In both studies, the NOAELs for developmental toxicity were higher than the NOAELs for maternal toxicity (300 mg/kg bw/day in both studies). Toxicokinetics 2-Phenoxyethanol is rapidly absorbed, distributed, metabolised and excreted. More than 90% of the dose recovered was excreted in urine, mainly as 2-phenoxyacetic acid, independent of the exposure route (rats, i.v., dermal, oral; hu","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"950","page":79,"route":"oral","species":"rat","study_id":"sccs_o_195_noael_061"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
75 |
- |
mouse |
oral |
126 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=unclear:Unlabeled table on page 75: NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) | Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, | Liver weight increase | NOAEL: 400 (males) 950 (females) | GLP study; EFFECT=Unlabeled table on page 75: NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) | Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, | Liver weight increase | NOAEL: 400 (males) 950 (females) | GLP study; CITATION=(ref. 15); CITATION_NUMBERS=[15]; REFERENCE=(ref. 15); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 15)","dose":"","duration":"126 days","effect":"Unlabeled table on page 75: NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) | Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, | Liver weight increase | NOAEL: 400 (males) 950 (females) | GLP study","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 75: NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) | Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, | Liver weight increase | NOAEL: 400 (males) 950 (females) | GLP study","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_094"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies |
reproductive toxicity |
400 |
- |
mouse |
oral |
126 days |
reproductive toxicity |
SOURCE_SUBDIR=sccs_o_195; REPORT_TITLE=OPINION ON Phenoxyethanol; OPINION_NUMBER=SCCS/1575/16; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=Final version of 6 October 2016; VALUE_TEXT=NOAEL: 400 (males) 950 (females); EFFECT=Unlabeled table on page 75: NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) | Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, | Liver weight increase | NOAEL: 400 (males) 950 (females) | GLP study; CITATION=(ref. 15); CITATION_NUMBERS=[15]; REFERENCE=(ref. 15); DETAILS_JSON={"cas_number":"122-99-6","citation":"(ref. 15)","dose":"","duration":"126 days","effect":"Unlabeled table on page 75: NTP 1984 (ref. 15); Heindel et al., 1990 (ref. 14) | Fertility study: CD-1 mouse, oral, F0, 126 days, diet Doses M: 0, 400, | Liver weight increase | NOAEL: 400 (males) 950 (females) | GLP study","endpoint":"reproductive toxicity","ingredient":"codes .................................... 6","loael_value":"","noael_unit":"","noael_value":"NOAEL: 400 (males) 950 (females)","page":75,"route":"oral","species":"mouse","study_id":"sccs_o_195_noael_102"} |