NOAEL Studies Cosmetic Ingredient

4-Hydroxypropylamino-3-Nitrophenol NOAEL Studies

INCI: 4-HYDROXYPROPYLAMINO-3-NITROPHENOL

CAS: 92952-81-3

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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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 10 mg/kg bw/day rat oral 91 day Subchronic SCCP; Husband, R.F.A and Newman, A.J. (1986). 13 Week Oral Toxicity Study in the Rat – WSI 72. Toxicol Laboratories Limited, Ledbury, England, internal study code SAK/10/C. Archive code at Henkel KGaA, Düsseldorf, Report No. R 9600327
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study.","effect":"ic Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) expressed its opinion (SCCNFP/0186/99) in the meeting on 23 June 1999 with the conclusion, that: the substance can be used safely as an oxidative hair dye at a maximum concentration of 5.2% and in semi permanent hair dying products with a concentration of 2.6%. Both product types should bear a label with the warning of risk of sensitisation. The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study. The substance and its salts are currently regulated in annex III/2, 7. Submission II was submitted by COLIPA in June 2005. Submission II presents updated scientific data on the above mentioned substance in line with the second step of the strategy for the evaluation of hair dyes (http://europa.eu.int/comm/enterprise/cosmetics/doc/hairdyestrategyinternet.pdf)) within the framework of the Cosmetics Directive 76/768/EEC. 2. TERMS OF REFERENCE 1. Does the Scientifi","page":5,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - 4 weeks NOAEL study {"citation":"Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS","dose":"The effect was dose related in severity and was greatly reduced after 4 weeks recovery.","effect":"ce or its metabolite(s). The effect was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase","page":14,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_002"}
SCCS_vision_codex NOAEL =30 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day.","effect":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day. 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 Reverse Mutation Test Guideline: OECD 471 Species/strain: TA 1535, TA 1537, TA 98, TA 100, TA 102 Replicates: 3 replicates in two independent experiments Test substance: COLIPA B100 Solvent: DMSO Batch: DALA 006721 Purity: 99.2% (area%, HPLC) Concentrations: 33, 100, 333, 1000, 2500 and 5000 µg/plate and in experiment two 10 µg/plat","page":15,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_005"}
SCCS_vision_codex NOAEL =0.02 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"henol 20 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_007"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"o 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_008"}
SCCS_vision_codex NOAEL =0.067 mg/kg rat oral 90-day dermal absorption {"dose":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_010"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study.","effect":"ic Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) expressed its opinion (SCCNFP/0186/99) in the meeting on 23 June 1999 with the conclusion, that: the substance can be used safely as an oxidative hair dye at a maximum concentration of 5.2% and in semi permanent hair dying products with a concentration of 2.6%. Both product types should bear a label with the warning of risk of sensitisation. The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study. The substance and its salts are currently regulated in annex III/2, 7. Submission II was submitted by COLIPA in June 2005. Submission II presents updated scientific data on the above mentioned substance in line with the second step of the strategy for the evaluation of hair dyes (http://europa.eu.int/comm/enterprise/cosmetics/doc/hairdyestrategyinternet.pdf)) within the framework of the Cosmetics Directive 76/768/EEC. 2. TERMS OF REFERENCE 1. Does the Scientifi","page":5,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - 4 weeks NOAEL study {"citation":"Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS","dose":"The effect was dose related in severity and was greatly reduced after 4 weeks recovery.","effect":"ce or its metabolite(s). The effect was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase","page":14,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_002"}
SCCS_vision_codex NOAEL =30 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day.","effect":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day. 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 Reverse Mutation Test Guideline: OECD 471 Species/strain: TA 1535, TA 1537, TA 98, TA 100, TA 102 Replicates: 3 replicates in two independent experiments Test substance: COLIPA B100 Solvent: DMSO Batch: DALA 006721 Purity: 99.2% (area%, HPLC) Concentrations: 33, 100, 333, 1000, 2500 and 5000 µg/plate and in experiment two 10 µg/plat","page":15,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_005"}
SCCS_vision_codex NOAEL =0.02 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"henol 20 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_007"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"o 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_008"}
SCCS_vision_codex NOAEL =0.067 mg/kg rat oral 90-day dermal absorption {"dose":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_010"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study.","effect":"ic Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) expressed its opinion (SCCNFP/0186/99) in the meeting on 23 June 1999 with the conclusion, that: the substance can be used safely as an oxidative hair dye at a maximum concentration of 5.2% and in semi permanent hair dying products with a concentration of 2.6%. Both product types should bear a label with the warning of risk of sensitisation. The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study. The substance and its salts are currently regulated in annex III/2, 7. Submission II was submitted by COLIPA in June 2005. Submission II presents updated scientific data on the above mentioned substance in line with the second step of the strategy for the evaluation of hair dyes (http://europa.eu.int/comm/enterprise/cosmetics/doc/hairdyestrategyinternet.pdf)) within the framework of the Cosmetics Directive 76/768/EEC. 2. TERMS OF REFERENCE 1. Does the Scientifi","page":5,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - 4 weeks NOAEL study {"citation":"Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS","dose":"The effect was dose related in severity and was greatly reduced after 4 weeks recovery.","effect":"ce or its metabolite(s). The effect was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase","page":14,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_002"}
SCCS_vision_codex NOAEL =30 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day.","effect":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day. 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 Reverse Mutation Test Guideline: OECD 471 Species/strain: TA 1535, TA 1537, TA 98, TA 100, TA 102 Replicates: 3 replicates in two independent experiments Test substance: COLIPA B100 Solvent: DMSO Batch: DALA 006721 Purity: 99.2% (area%, HPLC) Concentrations: 33, 100, 333, 1000, 2500 and 5000 µg/plate and in experiment two 10 µg/plat","page":15,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_005"}
SCCS_vision_codex NOAEL =0.02 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"henol 20 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_007"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"o 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_008"}
SCCS_vision_codex NOAEL =0.067 mg/kg rat oral 90-day dermal absorption {"dose":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_010"}
SCCS_vision_codex NOAEL =10 mg/kg bw rat oral subchronic repeated dose toxicity {"dose":"The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study.","effect":"ic Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) expressed its opinion (SCCNFP/0186/99) in the meeting on 23 June 1999 with the conclusion, that: the substance can be used safely as an oxidative hair dye at a maximum concentration of 5.2% and in semi permanent hair dying products with a concentration of 2.6%. Both product types should bear a label with the warning of risk of sensitisation. The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study. The substance and its salts are currently regulated in annex III/2, 7. Submission II was submitted by COLIPA in June 2005. Submission II presents updated scientific data on the above mentioned substance in line with the second step of the strategy for the evaluation of hair dyes (http://europa.eu.int/comm/enterprise/cosmetics/doc/hairdyestrategyinternet.pdf)) within the framework of the Cosmetics Directive 76/768/EEC. 2. TERMS OF REFERENCE 1. Does the Scientifi","page":5,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - 4 weeks NOAEL study {"citation":"Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS","dose":"The effect was dose related in severity and was greatly reduced after 4 weeks recovery.","effect":"ce or its metabolite(s). The effect was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase","page":14,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_002"}
SCCS_vision_codex NOAEL =30 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day.","effect":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day. 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 Reverse Mutation Test Guideline: OECD 471 Species/strain: TA 1535, TA 1537, TA 98, TA 100, TA 102 Replicates: 3 replicates in two independent experiments Test substance: COLIPA B100 Solvent: DMSO Batch: DALA 006721 Purity: 99.2% (area%, HPLC) Concentrations: 33, 100, 333, 1000, 2500 and 5000 µg/plate and in experiment two 10 µg/plat","page":15,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_005"}
SCCS_vision_codex NOAEL =0.02 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"henol 20 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_007"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","effect":"o 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_008"}
SCCS_vision_codex NOAEL =0.067 mg/kg rat oral 90-day dermal absorption {"dose":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 7...","effect":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.","page":20,"pdf":"sccp_o_119.pdf","row_type":"noael_study","study_id":"sccp_o_119_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 14 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 90 mg/kg bw/day - - 4 weeks - SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=90; DOSE=The effect was dose related in severity and was greatly reduced after 4 weeks recovery.; EFFECT=ce or its metabolite(s). The effect was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase; CITATION=Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS; CITATION_NUMBERS=[12,100,23,1999,10]; REFERENCE=Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS; DETAILS_JSON={"cas_number":"92952-81-3","citation":"Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS","dose":"The effect was dose related in severity and was greatly reduced after 4 weeks recovery.","duration":"4 weeks","effect":"ce or its metabolite(s). The effect was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase","endpoint":"","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"90","page":14,"route":"","species":"","study_id":"sccp_o_119_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 90 mg/kg bw/day - - 4 weeks - SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=90; DOSE=t was dose related in severity and was greatly reduced after 4 weeks recovery.; EFFECT=t was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase; CITATION=Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS; CITATION_NUMBERS=[12,100,23,1999,10]; REFERENCE=Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS; DETAILS_JSON={"cas_number":"92952-81-3","citation":"Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS","dose":"t was dose related in severity and was greatly reduced after 4 weeks recovery.","duration":"4 weeks","effect":"t was dose related in severity and was greatly reduced after 4 weeks recovery. No other treatment-related effects were observed at terminal necropsy. There were incidental changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase","endpoint":"","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"90","page":14,"route":"","species":"","study_id":"sccp_o_119_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 10 mg/kg bw - - - - SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=10; DOSE=ntal changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related.; EFFECT=ntal changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase; CITATION=Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS; CITATION_NUMBERS=[12,100,23,1999,10]; REFERENCE=Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS; DETAILS_JSON={"cas_number":"92952-81-3","citation":"Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS","dose":"ntal changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related.","duration":"","effect":"ntal changes in some haematological and blood chemistry parameters, but these were not-consistent or dose related. Orange coloration in urinary samples from the mid and high dose groups were observed. No substance related changes were seen in organ weight or histopathology. Conclusion According to the applicant, the No Observed Adverse Effect Level (NOAEL) for in this study was 90 mg/kg bw/day. Ref.: 12 Comment of the SCCP In the previous SCCNFP opinion on B100 of 23 June 1999, the same study was evaluated and a NOAEL of 10 mg/kg bw was used for the calculation of the MoS. For the present opinion, this study was re-assessed. The effects on Na, prothrombine time and kidney weight, as discussed in the previous opinion, were not dose-related or not consistent over time. Therefore, based on decrease ASAT in males in the highest dose group, and increase","endpoint":"","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":14,"route":"","species":"","study_id":"sccp_o_119_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.02 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 0.020; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...; EFFECT=henol 20 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","duration":"90-day","effect":"henol 20 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of","endpoint":"dermal absorption","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.020","page":20,"route":"oral","species":"rat","study_id":"sccp_o_119_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...; EFFECT=o 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","duration":"90-day","effect":"o 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 (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety","endpoint":"dermal absorption","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":20,"route":"oral","species":"rat","study_id":"sccp_o_119_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...; EFFECT=ta submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Sys...","duration":"90-day","effect":"ta submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 1.75 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.225 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemic","endpoint":"dermal absorption","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":20,"route":"oral","species":"rat","study_id":"sccp_o_119_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.067 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 0.067; DOSE=sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 7...; EFFECT=sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 7...","duration":"90-day","effect":"sure dose (SED) SAS x A x 0.001/60 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.","endpoint":"dermal absorption","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.067","page":20,"route":"oral","species":"rat","study_id":"sccp_o_119_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 30; DOSE=0 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per trea...; EFFECT=0 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"0 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per trea...","duration":"90-day","effect":"0 = 0.020 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.","endpoint":"dermal absorption","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":20,"route":"oral","species":"rat","study_id":"sccp_o_119_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 30; DOSE== 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of...; EFFECT== 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"= 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of...","duration":"90-day","effect":"= 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 1500 CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Non-oxidative conditions) Maximum absorption through the skin A (µg/cm2) = 5.72 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.004 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.067 mg/kg No observed adverse effect level NOAEL = 30 mg/kg (90-day, oral, rat) Margin of Safety NOAEL / SED = 448 3.3.14. Discussion Physico-chemical properties 4-Hydroxypropylamino-3-nitrophenol is used as an ingredient in hair colouring products up to a final concentration of 2.6% on head in the presence or absence of a developer-mix. 4- Hydroxypropylamino-3-nitrophenol is a secondary amine, and thus it is prone to nitrosation.","endpoint":"dermal absorption","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":20,"route":"oral","species":"rat","study_id":"sccp_o_119_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 90 mg/kg bw/day rat - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=90; DOSE=No dose-related effect was observed upon external, skeletal and visceral examinations of the foetuses.; EFFECT=losses, implantations, resorptions, uteri weights, placenta weights and corpora lutea between dosage groups and the control group. No dose-related effect was observed upon external, skeletal and visceral examinations of the foetuses. One single foetus in the high dose group was malformed by agnathia. This finding has also been observed, although sporadically in historical control rats. There is no indication that this finding is related to treatment. Conclusion Under the experimental conditions of this study, the NOAEL for both maternal and foetal toxicity was 90 mg/kg bw/day, the highest dose tested. Ref: 13 Comment For hazard identification, the highest dose used in teratogenicity studies should lead to maternal and/or developmental toxicity 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted; CITATION=Ref: 13 Comment For hazard identification, the highest dose used in teratogenicity studies should lead to maternal and/or developmental toxicity 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref: 13 Comment For hazard identification, the highest dose used in teratogenicity studies should lead to maternal and/or developmental toxicity 3; DETAILS_JSON={"cas_number":"92952-81-3","citation":"Ref: 13 Comment For hazard identification, the highest dose used in teratogenicity studies should lead to maternal and/or developmental toxicity 3","dose":"No dose-related effect was observed upon external, skeletal and visceral examinations of the foetuses.","duration":"developmental","effect":"losses, implantations, resorptions, uteri weights, placenta weights and corpora lutea between dosage groups and the control group. No dose-related effect was observed upon external, skeletal and visceral examinations of the foetuses. One single foetus in the high dose group was malformed by agnathia. This finding has also been observed, although sporadically in historical control rats. There is no indication that this finding is related to treatment. Conclusion Under the experimental conditions of this study, the NOAEL for both maternal and foetal toxicity was 90 mg/kg bw/day, the highest dose tested. Ref: 13 Comment For hazard identification, the highest dose used in teratogenicity studies should lead to maternal and/or developmental toxicity 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted","endpoint":"developmental toxicity","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"90","page":19,"route":"","species":"rat","study_id":"sccp_o_119_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 30 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=30; DOSE=SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day.; EFFECT=SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day. 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 Reverse Mutation Test Guideline: OECD 471 Species/strain: TA 1535, TA 1537, TA 98, TA 100, TA 102 Replicates: 3 replicates in two independent experiments Test substance: COLIPA B100 Solvent: DMSO Batch: DALA 006721 Purity: 99.2% (area%, HPLC) Concentrations: 33, 100, 333, 1000, 2500 and 5000 µg/plate and in experiment two 10 µg/plat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day.","duration":"Chronic","effect":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 15 of absolute thyroid weight (males and females in this group) the NOAEL is now set at 30 mg/kg bw/day. 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 Reverse Mutation Test Guideline: OECD 471 Species/strain: TA 1535, TA 1537, TA 98, TA 100, TA 102 Replicates: 3 replicates in two independent experiments Test substance: COLIPA B100 Solvent: DMSO Batch: DALA 006721 Purity: 99.2% (area%, HPLC) Concentrations: 33, 100, 333, 1000, 2500 and 5000 µg/plate and in experiment two 10 µg/plat","endpoint":"genotoxicity","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":15,"route":"","species":"","study_id":"sccp_o_119_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 30 mg/kg bw/day rat - 13-week irritation SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=30; DOSE=General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes.; EFFECT=SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 21 Nitrosamine content in 4-hydroxypropylamino-3-nitrophenol is not reported. This substance should not be used in combination with nitrosating agents. No data on the stability of 4-hydroxypropylamino-3-nitrophenol in marketed products and under oxidative conditions was reported. General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes. In a 13-week study in rats, the No Observed Adverse Effect Level (NOAEL) was set at 30 mg/kg bw/day. The NOAEL for both maternal and foetal toxicity was 90 mg/kg bw/day, the highest dose tested. The purity and composition of the test substance was not provided in any of the toxicity studies. Irritation / sensitisation Under the conditions of the study, the undiluted test substance produced no skin irritation. The study authors considered that staining of the skin did not hamper observations. The undiluted test substance was found to be irritating to the rabbit eye. Based on t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes.","duration":"13-week","effect":"SCCP/1082/07 Opinion on 4-hydroxypropylamino-3-nitrophenol 21 Nitrosamine content in 4-hydroxypropylamino-3-nitrophenol is not reported. This substance should not be used in combination with nitrosating agents. No data on the stability of 4-hydroxypropylamino-3-nitrophenol in marketed products and under oxidative conditions was reported. General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes. In a 13-week study in rats, the No Observed Adverse Effect Level (NOAEL) was set at 30 mg/kg bw/day. The NOAEL for both maternal and foetal toxicity was 90 mg/kg bw/day, the highest dose tested. The purity and composition of the test substance was not provided in any of the toxicity studies. Irritation / sensitisation Under the conditions of the study, the undiluted test substance produced no skin irritation. The study authors considered that staining of the skin did not hamper observations. The undiluted test substance was found to be irritating to the rabbit eye. Based on t","endpoint":"irritation","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":21,"route":"","species":"rat","study_id":"sccp_o_119_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 30 mg/kg bw/day rat - 13-week irritation SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=30; DOSE=General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes.; EFFECT=07 Opinion on 4-hydroxypropylamino-3-nitrophenol 21 Nitrosamine content in 4-hydroxypropylamino-3-nitrophenol is not reported. This substance should not be used in combination with nitrosating agents. No data on the stability of 4-hydroxypropylamino-3-nitrophenol in marketed products and under oxidative conditions was reported. General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes. In a 13-week study in rats, the No Observed Adverse Effect Level (NOAEL) was set at 30 mg/kg bw/day. The NOAEL for both maternal and foetal toxicity was 90 mg/kg bw/day, the highest dose tested. The purity and composition of the test substance was not provided in any of the toxicity studies. Irritation / sensitisation Under the conditions of the study, the undiluted test substance produced no skin irritation. The study authors considered that staining of the skin did not hamper observations. The undiluted test substance was found to be irritating to the rabbit eye. Based on the criteria of the test system, the test subst; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes.","duration":"13-week","effect":"07 Opinion on 4-hydroxypropylamino-3-nitrophenol 21 Nitrosamine content in 4-hydroxypropylamino-3-nitrophenol is not reported. This substance should not be used in combination with nitrosating agents. No data on the stability of 4-hydroxypropylamino-3-nitrophenol in marketed products and under oxidative conditions was reported. General toxicity The LD50 was greater than 2000 mg/kg bw for rats of both sexes. In a 13-week study in rats, the No Observed Adverse Effect Level (NOAEL) was set at 30 mg/kg bw/day. The NOAEL for both maternal and foetal toxicity was 90 mg/kg bw/day, the highest dose tested. The purity and composition of the test substance was not provided in any of the toxicity studies. Irritation / sensitisation Under the conditions of the study, the undiluted test substance produced no skin irritation. The study authors considered that staining of the skin did not hamper observations. The undiluted test substance was found to be irritating to the rabbit eye. Based on the criteria of the test system, the test subst","endpoint":"irritation","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":21,"route":"","species":"rat","study_id":"sccp_o_119_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 10 mg/kg bw rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_119; REPORT_TITLE=OPINION ON 4-Hydroxypropylamino-3-nitrophenol COLIPA n° B100; OPINION_NUMBER=SCCP/1082/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=10; DOSE=The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study.; EFFECT=ic Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) expressed its opinion (SCCNFP/0186/99) in the meeting on 23 June 1999 with the conclusion, that: the substance can be used safely as an oxidative hair dye at a maximum concentration of 5.2% and in semi permanent hair dying products with a concentration of 2.6%. Both product types should bear a label with the warning of risk of sensitisation. The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study. The substance and its salts are currently regulated in annex III/2, 7. Submission II was submitted by COLIPA in June 2005. Submission II presents updated scientific data on the above mentioned substance in line with the second step of the strategy for the evaluation of hair dyes (http://europa.eu.int/comm/enterprise/cosmetics/doc/hairdyestrategyinternet.pdf)) within the framework of the Cosmetics Directive 76/768/EEC. 2. TERMS OF REFERENCE 1. Does the Scientifi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"92952-81-3","citation":"","dose":"The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study.","duration":"subchronic","effect":"ic Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) expressed its opinion (SCCNFP/0186/99) in the meeting on 23 June 1999 with the conclusion, that: the substance can be used safely as an oxidative hair dye at a maximum concentration of 5.2% and in semi permanent hair dying products with a concentration of 2.6%. Both product types should bear a label with the warning of risk of sensitisation. The substance had a margin of safety at 89 for use as an oxidative hair dye based on a NOAEL of 10 mg/kg bw from a subchronic oral rat study. The substance and its salts are currently regulated in annex III/2, 7. Submission II was submitted by COLIPA in June 2005. Submission II presents updated scientific data on the above mentioned substance in line with the second step of the strategy for the evaluation of hair dyes (http://europa.eu.int/comm/enterprise/cosmetics/doc/hairdyestrategyinternet.pdf)) within the framework of the Cosmetics Directive 76/768/EEC. 2. TERMS OF REFERENCE 1. Does the Scientifi","endpoint":"repeated dose toxicity","ingredient":"4-Hydroxypropylamino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":5,"route":"oral","species":"rat","study_id":"sccp_o_119_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier X89W3M6X79 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"X89W3M6X79"}
openFDA substances FDA UNII substance identifier X89W3M6X79 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"X89W3M6X79"}
openFDA substances FDA UNII substance identifier X89W3M6X79 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"X89W3M6X79"}
openFDA substances FDA UNII substance identifier X89W3M6X79 UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"X89W3M6X79"}