NOAEL Studies Cosmetic Ingredient

P-METHYLAMINOPHENOL SULFATE NOAEL Studies

CAS: 150-75-4

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =10 mg/kg/day - - Chronic carcinogenicity {"citation":"Ref.: 5 3","dose":"Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.","effect":"nge in haematological and blood biochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity","page":14,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"ameters evaluated were affected by treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"y groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_005"}
SCCS_vision_codex NOAEL =0.047 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"ata 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and a","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_006"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"a 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_009"}
SCCS_vision_codex NOAEL =10 mg/kg/day - - Chronic carcinogenicity {"citation":"Ref.: 5 3","dose":"Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.","effect":"nge in haematological and blood biochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity","page":14,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"ameters evaluated were affected by treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"y groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_005"}
SCCS_vision_codex NOAEL =0.047 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"ata 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and a","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_006"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"a 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_009"}
SCCS_vision_codex NOAEL =10 mg/kg/day - - Chronic carcinogenicity {"citation":"Ref.: 5 3","dose":"Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.","effect":"nge in haematological and blood biochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity","page":14,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"ameters evaluated were affected by treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"y groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_005"}
SCCS_vision_codex NOAEL =0.047 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"ata 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and a","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_006"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"a 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_009"}
SCCS_vision_codex NOAEL =10 mg/kg/day - - Chronic carcinogenicity {"citation":"Ref.: 5 3","dose":"Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.","effect":"nge in haematological and blood biochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity","page":14,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"ameters evaluated were affected by treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg/day - - - NOAEL study {"citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","effect":"y groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","page":21,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_005"}
SCCS_vision_codex NOAEL =0.047 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"ata 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and a","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_006"}
SCCS_vision_codex NOAEL =5 mg/kg rat oral prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","effect":"a 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_007"}
SCCS_vision_codex NOAEL =10 mg/kg bw/day rat oral prenatal developmental toxicity {"dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).","page":22,"pdf":"sccp_o_039.pdf","row_type":"noael_study","study_id":"sccp_o_039_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 10 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5 mg/kg/day - - - - SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=5; DOSE=Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.; EFFECT=ameters evaluated were affected by treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted; CITATION=Ref: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref: 13 3; DETAILS_JSON={"cas_number":"150-75-4","citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","duration":"","effect":"ameters evaluated were affected by treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"5","page":21,"route":"","species":"","study_id":"sccp_o_039_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 5 mg/kg/day - - - - SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=5; DOSE=Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.; EFFECT=treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted; CITATION=Ref: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref: 13 3; DETAILS_JSON={"cas_number":"150-75-4","citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","duration":"","effect":"treatment with the test item. Foetal evaluation There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"5","page":21,"route":"","species":"","study_id":"sccp_o_039_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 125 mg/kg/day - - - - SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=125; DOSE=Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.; EFFECT=y groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted; CITATION=Ref: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref: 13 3; DETAILS_JSON={"cas_number":"150-75-4","citation":"Ref: 13 3","dose":"Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day.","duration":"","effect":"y groups at external, soft tissue or skeletal examinations. Conclusion When compared to controls, the maternal body weight gain was slightly decreased at 25 and 125 mg/kg/day. None of the litter data examined were affected. No foetal malformations or variations were considered to be related to treatment. Consequently, under the experimental conditions of this study, a No Observed Adverse Effect Level (NOAEL) for maternal toxicity was set at 5 mg/kg/day, and the dose-level of 125 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity. Ref: 13 3.3.9. Toxicokinetics No data submitted","endpoint":"","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"125","page":21,"route":"","species":"","study_id":"sccp_o_039_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 10 mg/kg/day - - Chronic carcinogenicity SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=10; DOSE=Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.; EFFECT=nge in haematological and blood biochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity; CITATION=Ref.: 5 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref.: 5 3; DETAILS_JSON={"cas_number":"150-75-4","citation":"Ref.: 5 3","dose":"Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.","duration":"Chronic","effect":"nge in haematological and blood biochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity","endpoint":"carcinogenicity","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"10","page":14,"route":"","species":"","study_id":"sccp_o_039_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies carcinogenicity 10 mg/kg/day - - Chronic carcinogenicity SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=10; DOSE=Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.; EFFECT=ochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity; CITATION=Ref.: 5 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref.: 5 3; DETAILS_JSON={"cas_number":"150-75-4","citation":"Ref.: 5 3","dose":"Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day.","duration":"Chronic","effect":"ochemical parameters. Only a higher urinary volume and a lower specific gravity were noted in some males given 30 mg/kg/day. No effects on organ weights and no macroscopic findings were noted. Microscopic examination revealed tubular epithelial degeneration/single cell necrosis in the kidneys of animals given 30 mg/kg/day, and complete reversibility of these changes was noted at the end of the treatment-free period. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) is 10 mg/kg/day. Ref.: 5 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity","endpoint":"carcinogenicity","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"10","page":14,"route":"","species":"","study_id":"sccp_o_039_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =0.047 mg/kg rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 0.047; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...; EFFECT=ata 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"150-75-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","duration":"prenatal","effect":"ata 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and a","endpoint":"developmental toxicity","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.047","page":22,"route":"oral","species":"rat","study_id":"sccp_o_039_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =5 mg/kg rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...; EFFECT=a 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"150-75-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","duration":"prenatal","effect":"a 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 (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw","endpoint":"developmental toxicity","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 5","page":22,"route":"oral","species":"rat","study_id":"sccp_o_039_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =5 mg/kg rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 5; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...; EFFECT=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"150-75-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic e...","duration":"prenatal","effect":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (p-Methylaminophenol sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.01 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.807 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).","endpoint":"developmental toxicity","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 5","page":22,"route":"oral","species":"rat","study_id":"sccp_o_039_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 10 mg/kg bw/day rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=10; DOSE=body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.; EFFECT=body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"150-75-4","citation":"","dose":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.","duration":"prenatal","effect":"body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).","endpoint":"developmental toxicity","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":22,"route":"oral","species":"rat","study_id":"sccp_o_039_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 10 mg/kg bw/day rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccp_o_039; REPORT_TITLE=Opinion on p-METHYLAMINOPHENOL sulphate COLIPA N° A22; OPINION_NUMBER=SCCP/0963/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=10; DOSE=stemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.; EFFECT=stemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"150-75-4","citation":"","dose":"stemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14.","duration":"prenatal","effect":"stemic exposure dose (SED) SAS x A x 0.001/60 = 0.047 mg/kg No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg (oral, rat, prenatal developmental) Margin of Safety NOAEL / SED = 106 3.3.14. Discussion Physico-chemical properties p-Methylaminophenol sulphate is a secondary amine, and thus is prone to nitrosation. The nitrosamine content in p-methylaminophenol sulphate is not reported. The stability of the test material in marketed products is not reported. Toxicity The No Observed Adverse Effect Level (NOAEL) was set at 10 mg/kg bw/day (90 day, rat), at 5 mg/kg bw/day (maternal toxicity) and at 125 mg/kg bw/day (embryo-foetal toxicity).","endpoint":"developmental toxicity","ingredient":"p-Methylaminophenol sulphate (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":22,"route":"oral","species":"rat","study_id":"sccp_o_039_noael_010"}
openFDA substances 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier D3W0VWG12M UNII - - - chemical {"approval_status":null,"molecular_formula":"2C7H9NO.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D3W0VWG12M"}
openFDA substances FDA UNII substance identifier 11W1883EFB UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"11W1883EFB"}
openFDA substances FDA UNII substance identifier D3W0VWG12M UNII - - - chemical {"approval_status":null,"molecular_formula":"2C7H9NO.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D3W0VWG12M"}
openFDA substances FDA UNII substance identifier D3W0VWG12M UNII - - - chemical {"approval_status":null,"molecular_formula":"2C7H9NO.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D3W0VWG12M"}
openFDA substances FDA UNII substance identifier D3W0VWG12M UNII - - - chemical {"approval_status":null,"molecular_formula":"2C7H9NO.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D3W0VWG12M"}
openFDA substances FDA UNII substance identifier 11W1883EFB UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"11W1883EFB"}
openFDA substances FDA UNII substance identifier 11W1883EFB UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"11W1883EFB"}
openFDA substances FDA UNII substance identifier 11W1883EFB UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"11W1883EFB"}