NOAEL Studies Cosmetic Ingredient

Hydroxyethyl-2-Nitro-p-Toluidine NOAEL Studies

INCI: HYDROXYETHYL-2-NITRO-P-TOLUIDINE

CAS: 100418-33-5

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 40 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20 3","dose":"Post mortem showed tissue staining particularly fat especially in the high dose group.","effect":"Submission III stated that normal urine parameters were not altered, but there was no evidence. Post mortem showed tissue staining particularly fat especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was red in one animal from the both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: -(not specified in study but given as BRA 1/315, Submission III) Purity: 99.7 %, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled water Dosing period:","page":14,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group.","effect":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydro","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose.","effect":"mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_003"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day rat - 90-day dermal absorption {"dose":"In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.","effect":"c apparatus in the in vivo micronucleus test. The percutaneous absorption studies are considered inadequate. In the in vitro study, the concentration of hydroxyethyl-2-nitro-p-toluidine, 0.63 %, was not at the maximum concentration intended for hair colorants (1 %) and the experimental design was not pertinent. The variations in the results were such that the data could not be interpreted. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats can reasonably be set at 45 mg/kg bw/day.","page":21,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20, submission III 3","dose":"Post mortem showed tissue staining, particularly of fat and especially in the high dose group.","effect":"e parameters were not altered, but there was no evidence in the study report. Post mortem showed tissue staining, particularly of fat and especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was stained red in one animal from both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no other treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20, submission III 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: BRA 1/315 (not in study report, but stated in Submission III summary) Purity: 99.7%, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled","page":19,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Pur","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO Concentrations: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µ","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_003"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"ro-p-toluidine ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_004"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"_________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used a","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_005"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 58...","effect":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minut","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_006"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20 3","dose":"Post mortem showed tissue staining particularly fat especially in the high dose group.","effect":"Submission III stated that normal urine parameters were not altered, but there was no evidence. Post mortem showed tissue staining particularly fat especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was red in one animal from the both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: -(not specified in study but given as BRA 1/315, Submission III) Purity: 99.7 %, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled water Dosing period:","page":14,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group.","effect":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydro","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose.","effect":"mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_003"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day rat - 90-day dermal absorption {"dose":"In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.","effect":"c apparatus in the in vivo micronucleus test. The percutaneous absorption studies are considered inadequate. In the in vitro study, the concentration of hydroxyethyl-2-nitro-p-toluidine, 0.63 %, was not at the maximum concentration intended for hair colorants (1 %) and the experimental design was not pertinent. The variations in the results were such that the data could not be interpreted. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats can reasonably be set at 45 mg/kg bw/day.","page":21,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20 3","dose":"Post mortem showed tissue staining particularly fat especially in the high dose group.","effect":"Submission III stated that normal urine parameters were not altered, but there was no evidence. Post mortem showed tissue staining particularly fat especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was red in one animal from the both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: -(not specified in study but given as BRA 1/315, Submission III) Purity: 99.7 %, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled water Dosing period:","page":14,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group.","effect":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydro","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose.","effect":"mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_003"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day rat - 90-day dermal absorption {"dose":"In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.","effect":"c apparatus in the in vivo micronucleus test. The percutaneous absorption studies are considered inadequate. In the in vitro study, the concentration of hydroxyethyl-2-nitro-p-toluidine, 0.63 %, was not at the maximum concentration intended for hair colorants (1 %) and the experimental design was not pertinent. The variations in the results were such that the data could not be interpreted. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats can reasonably be set at 45 mg/kg bw/day.","page":21,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20, submission III 3","dose":"Post mortem showed tissue staining, particularly of fat and especially in the high dose group.","effect":"e parameters were not altered, but there was no evidence in the study report. Post mortem showed tissue staining, particularly of fat and especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was stained red in one animal from both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no other treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20, submission III 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: BRA 1/315 (not in study report, but stated in Submission III summary) Purity: 99.7%, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled","page":19,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Pur","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO Concentrations: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µ","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_003"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"ro-p-toluidine ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_004"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"_________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used a","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_005"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 58...","effect":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minut","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_006"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20, submission III 3","dose":"Post mortem showed tissue staining, particularly of fat and especially in the high dose group.","effect":"e parameters were not altered, but there was no evidence in the study report. Post mortem showed tissue staining, particularly of fat and especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was stained red in one animal from both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no other treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20, submission III 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: BRA 1/315 (not in study report, but stated in Submission III summary) Purity: 99.7%, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled","page":19,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Pur","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO Concentrations: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µ","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_003"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"ro-p-toluidine ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_004"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"_________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used a","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_005"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 58...","effect":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minut","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_006"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20 3","dose":"Post mortem showed tissue staining particularly fat especially in the high dose group.","effect":"Submission III stated that normal urine parameters were not altered, but there was no evidence. Post mortem showed tissue staining particularly fat especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was red in one animal from the both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: -(not specified in study but given as BRA 1/315, Submission III) Purity: 99.7 %, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled water Dosing period:","page":14,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group.","effect":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydro","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw - - Chronic genotoxicity {"citation":"Ref.: 21 (submission I, ref 9) 3","dose":"The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose.","effect":"mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO","page":15,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_003"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day rat - 90-day dermal absorption {"dose":"In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.","effect":"c apparatus in the in vivo micronucleus test. The percutaneous absorption studies are considered inadequate. In the in vitro study, the concentration of hydroxyethyl-2-nitro-p-toluidine, 0.63 %, was not at the maximum concentration intended for hair colorants (1 %) and the experimental design was not pertinent. The variations in the results were such that the data could not be interpreted. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats can reasonably be set at 45 mg/kg bw/day.","page":21,"pdf":"sccp_o_038.pdf","row_type":"noael_study","study_id":"sccp_o_038_noael_004"}
SCCS_vision_codex NOAEL =240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 20, submission III 3","dose":"Post mortem showed tissue staining, particularly of fat and especially in the high dose group.","effect":"e parameters were not altered, but there was no evidence in the study report. Post mortem showed tissue staining, particularly of fat and especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was stained red in one animal from both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no other treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20, submission III 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: BRA 1/315 (not in study report, but stated in Submission III summary) Purity: 99.7%, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled","page":19,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_001"}
SCCS_vision_codex NOAEL =90 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Pur","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_002"}
SCCS_vision_codex NOAEL =45 mg/kg bw/day - - Chronic genotoxicity {"dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO Concentrations: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µ","page":20,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_003"}
SCCS_vision_codex NOAEL =0.05 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"ro-p-toluidine ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_004"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","effect":"_________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used a","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_005"}
SCCS_vision_codex NOAEL =0.04 mg/kg bw/d rat oral 90 day dermal absorption {"dose":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 58...","effect":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minut","page":26,"pdf":"sccs_o_061.pdf","row_type":"noael_study","study_id":"sccs_o_061_noael_006"}
ToxValDB_ECHA_IUCLID 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =60 mg/kg bw/day Rat oral - developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabace4b0a7c65d1bb306; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9108?documentUUID=7656cd6b-cc29-4d91-bc42-958ce3e398e2; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=ECHA IUCLID:15821589:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_acb7ab4295d69d5368b442ab7980105b
ToxValDB_ECHA_IUCLID NOAEL =90 mg/kg bw/day Rat oral subchronic; 90 days subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaca9e4b0a7c65d1c026f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9108?documentUUID=7656cd6b-cc29-4d91-bc42-958ce3e398e2; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=ECHA IUCLID:15838374:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8a0aa9ad70f065276cee4d59a5b77ffd
ToxValDB_ECHA_IUCLID NOAEL =240 mg/kg bw/day Rat oral short-term; 4 weeks short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaca9e4b0a7c65d1c0271; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/9108?documentUUID=7656cd6b-cc29-4d91-bc42-958ce3e398e2; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=clinical biochemistry|organ weights and organ / body weight ratios|urinalysis; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|organ weight|urinalysis; STUDY_GROUP=ECHA IUCLID:15842773:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7c2b53302bd489767eda65f288fad9ba
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 45 mg/kg bw/day rat oral 90-day - SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=45; DOSE=In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.; EFFECT=S/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 27 Under oxidative conditions, the amount of hydroxyethyl-2-nitro-p-toluidine bioavailable from a hair dye formulation containing 1% of it is 5.20 µg/cm². General toxicity Hydroxyethyl-2-nitro-p-toluidine has low acute oral and dermal toxicity. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats was set at 45 mg/kg bw/day (see page 20). Based on the effects on the kidney in the 13 weeks oral toxicity study, a NOAEL of 45 mg/kg bw/day is used for the calculation of the MoS. Hydroxyethyl-2-nitro-p-toluidine did not cause maternal toxicity or embryotoxic effects at the concentrations used in this study. Hydroxyethyl-2-nitro-p-toluidine was rated as having a high permeability Papp 93.6 x 10-6 cm/sec in human intestinal epithelial cells that would; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.","duration":"90-day","effect":"S/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 27 Under oxidative conditions, the amount of hydroxyethyl-2-nitro-p-toluidine bioavailable from a hair dye formulation containing 1% of it is 5.20 µg/cm². General toxicity Hydroxyethyl-2-nitro-p-toluidine has low acute oral and dermal toxicity. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats was set at 45 mg/kg bw/day (see page 20). Based on the effects on the kidney in the 13 weeks oral toxicity study, a NOAEL of 45 mg/kg bw/day is used for the calculation of the MoS. Hydroxyethyl-2-nitro-p-toluidine did not cause maternal toxicity or embryotoxic effects at the concentrations used in this study. Hydroxyethyl-2-nitro-p-toluidine was rated as having a high permeability Papp 93.6 x 10-6 cm/sec in human intestinal epithelial cells that would","endpoint":"","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"45","page":27,"route":"oral","species":"rat","study_id":"sccs_o_061_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 45 mg/kg bw/day rat - 90-day dermal absorption SOURCE_SUBDIR=sccp_o_038; REPORT_TITLE=Opinion on Hydroxyethyl-2-nitro-p-toluidine COLIPA N° B75; OPINION_NUMBER=SCCP/0924/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=45; DOSE=In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.; EFFECT=c apparatus in the in vivo micronucleus test. The percutaneous absorption studies are considered inadequate. In the in vitro study, the concentration of hydroxyethyl-2-nitro-p-toluidine, 0.63 %, was not at the maximum concentration intended for hair colorants (1 %) and the experimental design was not pertinent. The variations in the results were such that the data could not be interpreted. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats can reasonably be set at 45 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.","duration":"90-day","effect":"c apparatus in the in vivo micronucleus test. The percutaneous absorption studies are considered inadequate. In the in vitro study, the concentration of hydroxyethyl-2-nitro-p-toluidine, 0.63 %, was not at the maximum concentration intended for hair colorants (1 %) and the experimental design was not pertinent. The variations in the results were such that the data could not be interpreted. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats can reasonably be set at 45 mg/kg bw/day.","endpoint":"dermal absorption","ingredient":"Hydroxyethyl-2-nitro-p-toluidine","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"45","page":21,"route":"","species":"rat","study_id":"sccp_o_038_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.05 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT== 0.05; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=ro-p-toluidine ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90 day","effect":"ro-p-toluidine ___________________________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is","endpoint":"dermal absorption","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.05","page":26,"route":"oral","species":"rat","study_id":"sccs_o_061_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =45 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT== 45; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...; EFFECT=_________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure...","duration":"90 day","effect":"_________________________________________________________________________ 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-2-nitro-p-toluidine (Oxidative conditions) Absorption through the skin A (mean + 1SD) = 5.20 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used a","endpoint":"dermal absorption","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 45","page":26,"route":"oral","species":"rat","study_id":"sccs_o_061_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.04 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT== 0.04; DOSE=on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 58...; EFFECT=on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minut; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 58...","duration":"90 day","effect":"on per treatment SAS x A x 0.001 = 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minut","endpoint":"dermal absorption","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.04","page":26,"route":"oral","species":"rat","study_id":"sccs_o_061_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =45 mg/kg bw/d rat oral 90 day dermal absorption SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT== 45; DOSE== 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...; EFFECT== 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minutes. Th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"= 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treat...","duration":"90 day","effect":"= 3.02 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.05 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 890 (Non-oxidative conditions) Absorption through the skin A (mean + 1SD) = 4.45 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.04 mg/kg bw/d No Observed Adverse Effect Level NOAEL = 45 mg/kg bw/d (90 day study, oral, rat) MOS = 1125 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-2-nitro-p-toluidine is used as a direct dye in hair dye formulations, both with and without oxidative agent, at a final maximum concentration of 1%. Hydroxyethyl-2- nitro-p-toluidine is a secondary amine, and thus it is prone to nitrosation. The nitrosamine content in the test material is not reported. The stability of methylgelb under oxidative conditions was shown over the period of 45 minutes. Th","endpoint":"dermal absorption","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 45","page":26,"route":"oral","species":"rat","study_id":"sccs_o_061_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 90 mg/kg bw - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_038; REPORT_TITLE=Opinion on Hydroxyethyl-2-nitro-p-toluidine COLIPA N° B75; OPINION_NUMBER=SCCP/0924/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=90; DOSE=in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group.; EFFECT=in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydro; CITATION=Ref.: 21 (submission I, ref 9) 3; CITATION_NUMBERS=[21,9,3]; REFERENCE=Ref.: 21 (submission I, ref 9) 3; DETAILS_JSON={"cas_number":"100418-33-5","citation":"Ref.: 21 (submission I, ref 9) 3","dose":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group.","duration":"Chronic","effect":"in the treated groups showed a loamy colour with deposits and dilatation of renal pelvis in the 90 mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydro","endpoint":"genotoxicity","ingredient":"Hydroxyethyl-2-nitro-p-toluidine","loael_value":"","noael_unit":"mg/kg bw","noael_value":"90","page":15,"route":"","species":"","study_id":"sccp_o_038_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 45 mg/kg bw - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_038; REPORT_TITLE=Opinion on Hydroxyethyl-2-nitro-p-toluidine COLIPA N° B75; OPINION_NUMBER=SCCP/0924/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=45; DOSE=The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose.; EFFECT=mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO; CITATION=Ref.: 21 (submission I, ref 9) 3; CITATION_NUMBERS=[21,9,3]; REFERENCE=Ref.: 21 (submission I, ref 9) 3; DETAILS_JSON={"cas_number":"100418-33-5","citation":"Ref.: 21 (submission I, ref 9) 3","dose":"The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose.","duration":"Chronic","effect":"mg/kg bw group. The incidence of lobular structure of the liver increased in the control and the lower dose groups, but was less frequent at the top dose. There were no histopathological treatment-related changes observed. Comment The lack of data on the loss of stability and hence possible alteration of the test substance suspensions over the dosing period was not investigated. The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw. Based on the effects on the kidney, the SCCP considered the NOAEL should be 45 mg/kg bw. Ref.: 21 (submission I, ref 9) 3.3.5.3. Chronic (> 12 months) toxicity No data available 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: Two independent tests (plate incorporation and pre-incubation) Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO","endpoint":"genotoxicity","ingredient":"Hydroxyethyl-2-nitro-p-toluidine","loael_value":"","noael_unit":"mg/kg bw","noael_value":"45","page":15,"route":"","species":"","study_id":"sccp_o_038_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 90 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=90; DOSE=SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.; EFFECT=SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Pur; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","duration":"Chronic","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Pur","endpoint":"genotoxicity","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"90","page":20,"route":"","species":"","study_id":"sccs_o_061_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 45 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=45; DOSE=SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.; EFFECT=SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO Concentrations: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µ; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day.","duration":"Chronic","effect":"SCCS/1387/10 Opinion on hydroxyethyl-2-nitro-p-toluidine ___________________________________________________________________________________________ 20 The study authors suggested that the NOAEL could be deduced as 90 mg/kg bw/day. Based on the effects on the kidney, the SCCS considered the NOAEL should be 45 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 gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA102, TA1535, TA1537 Replicates: triplicate cultures in two independent tests Test substance: WR 20883 Methylgelb Batch: 6718 Fass 10/20 Purity: 99.8 area% (HPLC; 254 nm) Vehicle: DMSO Concentrations: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µ","endpoint":"genotoxicity","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"45","page":20,"route":"","species":"","study_id":"sccs_o_061_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 45 mg/kg bw/day rat oral 90-day genotoxicity SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=45; DOSE=In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.; EFFECT=ount of hydroxyethyl-2-nitro-p-toluidine bioavailable from a hair dye formulation containing 1% of it is 5.20 µg/cm². General toxicity Hydroxyethyl-2-nitro-p-toluidine has low acute oral and dermal toxicity. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats was set at 45 mg/kg bw/day (see page 20). Based on the effects on the kidney in the 13 weeks oral toxicity study, a NOAEL of 45 mg/kg bw/day is used for the calculation of the MoS. Hydroxyethyl-2-nitro-p-toluidine did not cause maternal toxicity or embryotoxic effects at the concentrations used in this study. Hydroxyethyl-2-nitro-p-toluidine was rated as having a high permeability Papp 93.6 x 10-6 cm/sec in human intestinal epithelial cells that would indicate very good intestinal absorption. Mutagenicity Overall, the genotoxicity of hydroxyethyl-2-nitro-p-toluidine is sufficiently investigated in valid genotoxicity tests for the 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"100418-33-5","citation":"","dose":"In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible.","duration":"90-day","effect":"ount of hydroxyethyl-2-nitro-p-toluidine bioavailable from a hair dye formulation containing 1% of it is 5.20 µg/cm². General toxicity Hydroxyethyl-2-nitro-p-toluidine has low acute oral and dermal toxicity. In repeated-dose studies, clinical signs of toxicity were minimal and the histological changes observed were reversible. The NOAEL for general toxicity in the 90-day repeat-dose studies in rats was set at 45 mg/kg bw/day (see page 20). Based on the effects on the kidney in the 13 weeks oral toxicity study, a NOAEL of 45 mg/kg bw/day is used for the calculation of the MoS. Hydroxyethyl-2-nitro-p-toluidine did not cause maternal toxicity or embryotoxic effects at the concentrations used in this study. Hydroxyethyl-2-nitro-p-toluidine was rated as having a high permeability Papp 93.6 x 10-6 cm/sec in human intestinal epithelial cells that would indicate very good intestinal absorption. Mutagenicity Overall, the genotoxicity of hydroxyethyl-2-nitro-p-toluidine is sufficiently investigated in valid genotoxicity tests for the 3","endpoint":"genotoxicity","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"45","page":27,"route":"oral","species":"rat","study_id":"sccs_o_061_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_038; REPORT_TITLE=Opinion on Hydroxyethyl-2-nitro-p-toluidine COLIPA N° B75; OPINION_NUMBER=SCCP/0924/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=240; DOSE=Post mortem showed tissue staining particularly fat especially in the high dose group.; EFFECT=Submission III stated that normal urine parameters were not altered, but there was no evidence. Post mortem showed tissue staining particularly fat especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was red in one animal from the both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: -(not specified in study but given as BRA 1/315, Submission III) Purity: 99.7 %, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled water Dosing period:; CITATION=Ref.: 20 3; CITATION_NUMBERS=[20,3]; REFERENCE=Ref.: 20 3; DETAILS_JSON={"cas_number":"100418-33-5","citation":"Ref.: 20 3","dose":"Post mortem showed tissue staining particularly fat especially in the high dose group.","duration":"Sub-chronic","effect":"Submission III stated that normal urine parameters were not altered, but there was no evidence. Post mortem showed tissue staining particularly fat especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was red in one animal from the both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: -(not specified in study but given as BRA 1/315, Submission III) Purity: 99.7 %, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled water Dosing period:","endpoint":"repeated dose toxicity","ingredient":"Hydroxyethyl-2-nitro-p-toluidine","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"240","page":14,"route":"oral","species":"rat","study_id":"sccp_o_038_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 240 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_061; REPORT_TITLE=OPINION ON Hydroxyethyl-2-nitro-p-toluidine COLIPA n° B75; OPINION_NUMBER=SCCS/1387/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted on 23 June 1999; VALUE_TEXT=240; DOSE=Post mortem showed tissue staining, particularly of fat and especially in the high dose group.; EFFECT=e parameters were not altered, but there was no evidence in the study report. Post mortem showed tissue staining, particularly of fat and especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was stained red in one animal from both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no other treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20, submission III 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: BRA 1/315 (not in study report, but stated in Submission III summary) Purity: 99.7%, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled; CITATION=Ref.: 20, submission III 3; CITATION_NUMBERS=[20,3]; REFERENCE=Ref.: 20, submission III 3; DETAILS_JSON={"cas_number":"100418-33-5","citation":"Ref.: 20, submission III 3","dose":"Post mortem showed tissue staining, particularly of fat and especially in the high dose group.","duration":"Sub-chronic","effect":"e parameters were not altered, but there was no evidence in the study report. Post mortem showed tissue staining, particularly of fat and especially in the high dose group. Statistically significant changes at the high dose were lower absolute adrenal weights in females and relative liver weights in males. The thymus was stained red in one animal from both the mid and high dose male groups. Kidney weight was affected but there was no dose response or consistency. There were no other treatment related findings. The NOAEL was deduced to be 240 mg/kg bw/day from this study. Ref.: 20, submission III 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Sub-chronic (90 days) oral toxicity Guideline: OECD 408 (1981) Species/strain: Rat, Sprague Dawley Crl:CD (SD) BR Group size: 10 per dose and sex Test substance: Hydroxyethyl-2-nitro-p-toluidine Batch: BRA 1/315 (not in study report, but stated in Submission III summary) Purity: 99.7%, HPLC Doses: 0, 10, 45 and 90 mg/kg bw/day oral gavage, 7days/week Vehicle: distilled","endpoint":"repeated dose toxicity","ingredient":"was submitted to the SCCNFP in 14 January 2002. On 18 March","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"240","page":19,"route":"oral","species":"rat","study_id":"sccs_o_061_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier KL22OLP94K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KL22OLP94K"}
openFDA substances FDA UNII substance identifier KL22OLP94K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KL22OLP94K"}
openFDA substances FDA UNII substance identifier KL22OLP94K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KL22OLP94K"}
openFDA substances FDA UNII substance identifier KL22OLP94K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H12N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KL22OLP94K"}