NOAEL Studies
Cosmetic Ingredient
2-Hydroxyethyl Picramic Acid NOAEL Studies
INCI: 2-HYDROXYETHYL PICRAMIC ACID
CAS: 99610-72-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 20 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCP; Weide, J.; 3-monatige Toxizitätsprüfung an Ratten mit der Testsubstanz Pikraminrot;WELLA AG; 1985 |
SCCS_vision_codex 40 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 (submission I) 3","dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_001"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","dose":"At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.","effect":"water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_002"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 24 3","dose":"HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.","effect":"ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9","page":18,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_003"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | 12 to day | NOAEL study | {"citation":"Ref.: 32 3","dose":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.","effect":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_005"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_007"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_008"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw | rabbit | dermal | 28-day | reproductive toxicity | {"dose":"foeto/embryotoxicity is 50 mg/kg bw/day.","effect":"foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA. Dermal absorption The maximum amount of 2-Hydroxyethyl picramic acid absorbed into the skin (lower skin + receptor fluid) i.e. 13.64 µg/cm2 may be used for the","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.16 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"city No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124","page":26,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.13 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...","effect":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-h","page":27,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_010"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 (submission I) 3","dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_001"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","dose":"At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.","effect":"water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_002"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 24 3","dose":"HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.","effect":"ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9","page":18,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_003"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | 12 to day | NOAEL study | {"citation":"Ref.: 32 3","dose":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.","effect":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_005"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_007"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_008"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw | rabbit | dermal | 28-day | reproductive toxicity | {"dose":"foeto/embryotoxicity is 50 mg/kg bw/day.","effect":"foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA. Dermal absorption The maximum amount of 2-Hydroxyethyl picramic acid absorbed into the skin (lower skin + receptor fluid) i.e. 13.64 µg/cm2 may be used for the","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_011"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 (submission I) 3","dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_001"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","dose":"At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.","effect":"water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_002"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 24 3","dose":"HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.","effect":"ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9","page":18,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_003"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | 12 to day | NOAEL study | {"citation":"Ref.: 32 3","dose":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.","effect":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_005"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_007"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_008"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw | rabbit | dermal | 28-day | reproductive toxicity | {"dose":"foeto/embryotoxicity is 50 mg/kg bw/day.","effect":"foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA. Dermal absorption The maximum amount of 2-Hydroxyethyl picramic acid absorbed into the skin (lower skin + receptor fluid) i.e. 13.64 µg/cm2 may be used for the","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.16 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"city No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124","page":26,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.13 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...","effect":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-h","page":27,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.16 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"city No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124","page":26,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.13 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...","effect":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-h","page":27,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_010"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw | - | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 (submission I) 3","dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_001"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","dose":"At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.","effect":"water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","page":17,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_002"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | - | Chronic | genotoxicity | {"citation":"Ref.: 24 3","dose":"HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.","effect":"ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9","page":18,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_003"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | {"dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels.","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_004"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | 12 to day | NOAEL study | {"citation":"Ref.: 32 3","dose":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.","effect":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation","page":25,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_005"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg bw | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_007"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | {"dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","effect":"he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_008"} |
| SCCS_vision_codex | NOAEL | =120 | mg/kg bw | rabbit | dermal | 28-day | reproductive toxicity | {"dose":"foeto/embryotoxicity is 50 mg/kg bw/day.","effect":"foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA. Dermal absorption The maximum amount of 2-Hydroxyethyl picramic acid absorbed into the skin (lower skin + receptor fluid) i.e. 13.64 µg/cm2 may be used for the","page":27,"pdf":"sccp_o_102.pdf","row_type":"noael_study","study_id":"sccp_o_102_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.16 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"city No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124","page":26,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.13 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...","effect":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-h","page":27,"pdf":"sccp_o_158.pdf","row_type":"noael_study","study_id":"sccp_o_158_noael_010"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 27 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=20; DOSE=At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.; EFFECT=water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP); CITATION=Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP); CITATION_NUMBERS=[23,15,2]; REFERENCE=Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP); DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","dose":"At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.","duration":"","effect":"water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","endpoint":"","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"20","page":17,"route":"","species":"rat","study_id":"sccp_o_102_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw/day | human | - | 12 to day | - | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=50; DOSE=150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.; EFFECT=150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation; CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 32 3","dose":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.","duration":"12 to day","effect":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation","endpoint":"","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":25,"route":"","species":"human","study_id":"sccp_o_102_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw/day | human | - | 12 to day | - | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=50; DOSE=Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls.; EFFECT=city as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation; CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 32 3","dose":"Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls.","duration":"12 to day","effect":"city as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: / Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50 microM in HBSS buffer, 1% DMSO Route: / Exposure: 60 minutes incubation","endpoint":"","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":25,"route":"","species":"human","study_id":"sccp_o_102_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=20; DOSE=At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.; EFFECT=water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP); CITATION=Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP); CITATION_NUMBERS=[23,15,2]; REFERENCE=Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP); DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","dose":"At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above.","duration":"","effect":"water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular strain of rats. The absolute and the relative organ weights were not affected by the exposure. At histopathology an activation of the thyroid epithelial cells in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw/day and above. They were interpreted as treatment related effects. Conclusion The NOAEL was defined at 20 mg/kg bw per day. Ref.: 23 Guideline: / Species/strain: Wistar Group size: 15 per sex 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP)","endpoint":"","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"20","page":17,"route":"","species":"rat","study_id":"sccp_o_158_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw/day | human | - | 12 to day | - | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=50; DOSE=150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.; EFFECT=150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: /; CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 32 3","dose":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation.","duration":"12 to day","effect":"150 and 450 mg/kg bw/day HEP caused some maternal toxicity as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: /","endpoint":"","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":25,"route":"","species":"human","study_id":"sccp_o_158_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | mg/kg bw/day | human | - | 12 to day | - | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=50; DOSE=Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls.; EFFECT=city as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: /; CITATION=Ref.: 32 3; CITATION_NUMBERS=[32,3]; REFERENCE=Ref.: 32 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 32 3","dose":"Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls.","duration":"12 to day","effect":"city as indicated by the reduction in body weight from day 12 to day 20 of gestation. A reduction in food consumption was also reported. Gravid uterus weight was lower in 450 mg/kg bw/day group compared to controls. An increased incidence of abdominal haemorrhages in foetuses was noted at the mid and high dose group. In the high dose group a delay in development of foetuses was noted (small foetuses and delayed ossification) For 2-hydroxyethylpicarmic acid the NOAEL of maternal toxicity is 50 mg/kg bw/day and the NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. Ref.: 32 3.3.9. Toxicokinetics Guideline: / Species/strain: Human intestinal epithelial cell line TC-7 Group size: /","endpoint":"","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":25,"route":"","species":"human","study_id":"sccp_o_158_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.16 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 0.16; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=city No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90-day","effect":"city No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124","endpoint":"dermal absorption","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.16","page":26,"route":"oral","species":"rat","study_id":"sccp_o_158_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =20 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90-day","effect":"Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124","endpoint":"dermal absorption","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 20","page":26,"route":"oral","species":"rat","study_id":"sccp_o_158_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =20 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 20; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=ons No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90-day","effect":"ons No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-hydroxyethyl picramic acid (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 13.85 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.16 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 124","endpoint":"dermal absorption","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 20","page":26,"route":"oral","species":"rat","study_id":"sccp_o_158_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.13 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 0.13; DOSE=SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...; EFFECT=SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-h; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...","duration":"90-day","effect":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-h","endpoint":"dermal absorption","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.13","page":27,"route":"oral","species":"rat","study_id":"sccp_o_158_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =20 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 20; DOSE=SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...; EFFECT=SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-hydroxy; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13...","duration":"90-day","effect":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 27 2-hydroxyethyl picramic acid (oxidative) Maximum absorption through the skin A (μg/cm2) = 11.38 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 8.00 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.13 mg/kg bw No observed adverse effect level NOAEL = 20 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 151 3.3.14. Discussion Physico-chemical properties 2-Hydroxyethyl picramic acid is used as a hair colouring agent in oxidative hair dye formulations at a maximum on-head concentration of 1.5%, after mixing with hydrogen peroxide and it is also used as a hair colouring agent in semi-permanent hair dye formulations at a maximum on-head concentration of 2%. Supportive document for the reported data on purity/impurities for only 2 batches of 2-hydroxy","endpoint":"dermal absorption","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 20","page":27,"route":"oral","species":"rat","study_id":"sccp_o_158_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 15 | mg/kg bw | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=15; DOSE=HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.; EFFECT=ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 24 3","dose":"HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.","duration":"Chronic","effect":"ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9","endpoint":"genotoxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"15","page":18,"route":"","species":"rat","study_id":"sccp_o_102_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 15 | mg/kg bw | rat | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=15; DOSE=HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.; EFFECT=ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9; CITATION=Ref.: 24 3; CITATION_NUMBERS=[24,3]; REFERENCE=Ref.: 24 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 24 3","dose":"HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day.","duration":"Chronic","effect":"ot reveal any difference between the exposure groups and control animals. Food and water consumption and body weight gain was not affected by the HEP exposure. All figures in haematology, blood chemistry and urine analysis were with in the normal variation of this particular stain of rats. At necropsy no macroscopical findings were noted and no biologically relevant HEP related effects were reported for the absolute or relative organ weights. HEP related findings in histopathology were not reported Conclusion The NOAEL was defined at 15 mg/kg bw per day. Ref.: 24 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium, TA1535, TA1537, TA98, TA100 and TA1538 Replicates: Three plates per concentration in two independent experiments Assay conditions: Direct plate incorporation method, both in the presence and absence of Aroclor 1254 induced rat liver S9","endpoint":"genotoxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"15","page":18,"route":"","species":"rat","study_id":"sccp_o_158_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 50 | mg/kg bw | - | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=50; DOSE=SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.; EFFECT=SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week; CITATION=Ref.: 13 (submission I) 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 (submission I) 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 13 (submission I) 3","dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.","duration":"Sub-chronic","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week","endpoint":"repeated dose toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":17,"route":"oral","species":"","study_id":"sccp_o_102_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 50 | mg/kg bw | - | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=50; DOSE=SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.; EFFECT=SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week; CITATION=Ref.: 13 (submission I) 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 (submission I) 3; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 13 (submission I) 3","dose":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day.","duration":"Sub-chronic","effect":"SCCP/1208/08 Opinion on 2-hydroxyethyl picramic acid 17 The NOAEL was defined at 50 mg/kg bw per day. Ref.: 13 (submission I) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Wistar Group size: 15 per sex and dose group 15 animals per sex high dose satellite group Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: BR 624 Purity: >99.4% Dose: 20, 60 and 180/120 mg/kg bw/day Route: Oral in deionized water Exposure: 91 days, 5 days/week GLP: in compliance Doses of 20, 60 and 180 mg/kg bw/day (120 mg/kg bw/day from week","endpoint":"repeated dose toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":17,"route":"oral","species":"","study_id":"sccp_o_158_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 120 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=120; DOSE=SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels.; EFFECT=SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels.","duration":"28-day","effect":"SCCP/1058/06 Opinion on 2-hydroxyethyl picramic acid 25 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":25,"route":"oral","species":"rat","study_id":"sccp_o_102_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 60 | mg/kg bw | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=60; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"60","page":27,"route":"","species":"rat","study_id":"sccp_o_102_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=20; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":27,"route":"","species":"rat","study_id":"sccp_o_102_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=20; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=or Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"or Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects w","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":27,"route":"","species":"rat","study_id":"sccp_o_102_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 50 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=50; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day.","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":27,"route":"","species":"rat","study_id":"sccp_o_102_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 120 | mg/kg bw | rabbit | dermal | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccp_o_102; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1058/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 June 2007; VALUE_TEXT=120; DOSE=foeto/embryotoxicity is 50 mg/kg bw/day.; EFFECT=foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA. Dermal absorption The maximum amount of 2-Hydroxyethyl picramic acid absorbed into the skin (lower skin + receptor fluid) i.e. 13.64 µg/cm2 may be used for the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"foeto/embryotoxicity is 50 mg/kg bw/day.","duration":"28-day","effect":"foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA. Dermal absorption The maximum amount of 2-Hydroxyethyl picramic acid absorbed into the skin (lower skin + receptor fluid) i.e. 13.64 µg/cm2 may be used for the","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"120","page":27,"route":"dermal","species":"rabbit","study_id":"sccp_o_102_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 120 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=120; DOSE=picramic acid 25 In the F1 generation the ratio of males: females were statistically significantly increased in the low and the mid dose groups compared to the control group, but not in the high exposure group.; EFFECT=picramic acid 25 In the F1 generation the ratio of males: females were statistically significantly increased in the low and the mid dose groups compared to the control group, but not in the high exposure group. In the F2 group the sex ratio was normal in all groups. HEP related macroscopic findings were not reported in the F1 and in the F2 generations. Ref.: 31 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl; CITATION=Ref.: 31 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels; CITATION_NUMBERS=[31,1]; REFERENCE=Ref.: 31 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels; DETAILS_JSON={"cas_number":"99610-72-7","citation":"Ref.: 31 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels","dose":"picramic acid 25 In the F1 generation the ratio of males: females were statistically significantly increased in the low and the mid dose groups compared to the control group, but not in the high exposure group.","duration":"28-day","effect":"picramic acid 25 In the F1 generation the ratio of males: females were statistically significantly increased in the low and the mid dose groups compared to the control group, but not in the high exposure group. In the F2 group the sex ratio was normal in all groups. HEP related macroscopic findings were not reported in the F1 and in the F2 generations. Ref.: 31 Comment The fertility and the reproduction parameters of the P and F1 parent animals, as well as their progeny were unaffected in any dose levels. The NOAEL for reproductive toxicity was set at 120 mg/kg bw/day. In the dose range finding study, testes atrophy was observed at 450mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. 3.3.8.2. Teratogenicity Guideline: OECD 414 Species/strain: rat/Sprague-Dawley (SD) Group size: 24 female per dose Test substance: 2-hydroxyethylpicramic acid (HEP) Batch: 2/99 Purity: >98.4% Dose: 50, 150, 450 mg/kg bw/day Route: Oral in 0.5 % aqueous carboxymethyl","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"120","page":25,"route":"oral","species":"rat","study_id":"sccp_o_158_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 60 | mg/kg bw | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=60; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"ogether with nitrosating agents. The test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the obser","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"60","page":27,"route":"","species":"rat","study_id":"sccp_o_158_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=20; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"he test material, batch 21989/8, used for Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":27,"route":"","species":"rat","study_id":"sccp_o_158_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=20; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=or Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"or Ames test was only 87% pure. However, the results of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects w","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":27,"route":"","species":"rat","study_id":"sccp_o_158_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 50 | mg/kg bw/day | rat | - | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=50; DOSE=General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.; EFFECT=of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively.","duration":"90 days","effect":"of this study did not influence the overall conclusion. General toxicity In a non GLP study the LD50 for male and female rats were 1134 and 900 mg/kg bw, respectively. LD50 for male and female mice were 525 mg/kg bw. In a 90 days study at histopathology an activation of the thyroid epithelial cell in males and protein cylinders in the kidney in both sexes were noted at 60 mg/kg bw and the No Observed Adverse Effect Level (NOAEL) was set to 20 mg/kg bw/day. The NOAEL for maternal toxicity was 50 mg/kg bw/day. The NOAEL of foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day.","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":27,"route":"","species":"rat","study_id":"sccp_o_158_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 120 | mg/kg bw | rabbit | - | 28-day | reproductive toxicity | SOURCE_SUBDIR=sccp_o_158; REPORT_TITLE=OPINION ON 2-Hydroxyethyl picramic acid COLIPA n° B72; OPINION_NUMBER=SCCP/1208/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=120; DOSE=foeto/embryotoxicity is 50 mg/kg bw/day.; EFFECT=foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"99610-72-7","citation":"","dose":"foeto/embryotoxicity is 50 mg/kg bw/day.","duration":"28-day","effect":"foeto/embryotoxicity is 50 mg/kg bw/day. 2-Hydroxyethyl picramic acid is classified as toxic to reproduction category 3 (R62: possible risk of impaired fertility). The assessment (BgVV, 1993) was based on testes atrophy in the 450 mg/kg bw/d dose group of the 28-day study. A 2-generation toxicity study was performed. In the dose range finding study, testes atrophy was observed at 450 mg/kg bw, similar to the observations of the 28-day study. No such effects were noted in the main study at 120 mg/kg bw per day. The NOAEL for reproductive toxicity was set at 120 mg/kg bw per day. Irritation / sensitisation 1-Hydroxy-2-(2’-hydroxyethyl)amino-4,6-dinitrobenzene is not irritant to rabbit skin, and it is slightly irritant to the rabbit eye under the conditions of the test. Under the test conditions, 2-Hydroxyethyl picramic acid was not shown to be a skin sensitiser in LLNA.","endpoint":"reproductive toxicity","ingredient":"2-Hydroxyethyl picramic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"120","page":27,"route":"","species":"rabbit","study_id":"sccp_o_158_noael_016"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | KZ27KOJ0GZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H9N3O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KZ27KOJ0GZ"} |
| openFDA substances | FDA UNII substance identifier | KZ27KOJ0GZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H9N3O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KZ27KOJ0GZ"} |
| openFDA substances | FDA UNII substance identifier | KZ27KOJ0GZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H9N3O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KZ27KOJ0GZ"} |
| openFDA substances | FDA UNII substance identifier | KZ27KOJ0GZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H9N3O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KZ27KOJ0GZ"} |