NOAEL Studies Cosmetic Ingredient

Hydroxyethyl-p-Phenylenediamine Sulfate NOAEL Studies

INCI: HYDROXYETHYL-P-PHENYLENEDIAMINE SULFATE

CAS: 93841-25-9

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 60 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =0.035 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"ate __________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice,","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_006"}
SCCS_vision_codex NOAEL =0.035 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"ate __________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice,","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_006"}
SCCS_vision_codex NOAEL =0.035 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"ate __________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice,","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_006"}
SCCS_vision_codex NOAEL =0.035 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"ate __________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice,","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_006"}
SCCS_vision_codex NOAEL =25 mg/kg bw rat oral 90 days NOAEL study {"citation":"Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dih","dose":"The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group.","effect":"for 90 days. Food consumption and body weight gain were normal. From the 11th to 13th week, orange coloured urine was observed and the frequency of this observation increased with the higher doses. No ophthalmoscopic and haematological changes, weight deviations and macroscopic changes of the organs were found. All histomorphological findings were not test substance dependent. The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group. The no-effect level (NOEL) was set at 25 mg/kg bw. Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dihydrochloride Purity : 99 % Batch no : / Dose levels : 5 ml/kg (control), 25mg/kg (test) Observation period : 12 week application GLP : / The substance (hydrochloride) was administered daily by gavage to 12 male and 12 female SPW Wistar rats for 12 weeks at a dose of 25 mg/kg/bw. A control grou","page":10,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - sub-chronic repeated dose toxicity {"dose":"A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day.","effect":"enylenediamine sulfate 15 No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion On the basis of the results of acute toxicity studies, A80 should be classified as ‘toxic’ (EC criteria). A80 does not show eye- or skin irritation at the ‘in-use concentration’ and was negative in a maximisation test. A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day. The in vitro and in vivo studies on percutaneous absorption are all inadequate; an assessment could not be done. The in vitro studies on mutagenicity are all inadequate; an assessment could not be done. 4. CONCLUSION The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: * complete physico-che","page":15,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_002"}
SCCS_vision_codex NOAEL =25 mg/kg bw rat oral 90 days NOAEL study {"citation":"Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dih","dose":"The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group.","effect":"for 90 days. Food consumption and body weight gain were normal. From the 11th to 13th week, orange coloured urine was observed and the frequency of this observation increased with the higher doses. No ophthalmoscopic and haematological changes, weight deviations and macroscopic changes of the organs were found. All histomorphological findings were not test substance dependent. The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group. The no-effect level (NOEL) was set at 25 mg/kg bw. Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dihydrochloride Purity : 99 % Batch no : / Dose levels : 5 ml/kg (control), 25mg/kg (test) Observation period : 12 week application GLP : / The substance (hydrochloride) was administered daily by gavage to 12 male and 12 female SPW Wistar rats for 12 weeks at a dose of 25 mg/kg/bw. A control grou","page":10,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - sub-chronic repeated dose toxicity {"dose":"A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day.","effect":"enylenediamine sulfate 15 No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion On the basis of the results of acute toxicity studies, A80 should be classified as ‘toxic’ (EC criteria). A80 does not show eye- or skin irritation at the ‘in-use concentration’ and was negative in a maximisation test. A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day. The in vitro and in vivo studies on percutaneous absorption are all inadequate; an assessment could not be done. The in vitro studies on mutagenicity are all inadequate; an assessment could not be done. 4. CONCLUSION The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: * complete physico-che","page":15,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_002"}
SCCS_vision_codex NOAEL =25 mg/kg bw rat oral 90 days NOAEL study {"citation":"Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dih","dose":"The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group.","effect":"for 90 days. Food consumption and body weight gain were normal. From the 11th to 13th week, orange coloured urine was observed and the frequency of this observation increased with the higher doses. No ophthalmoscopic and haematological changes, weight deviations and macroscopic changes of the organs were found. All histomorphological findings were not test substance dependent. The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group. The no-effect level (NOEL) was set at 25 mg/kg bw. Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dihydrochloride Purity : 99 % Batch no : / Dose levels : 5 ml/kg (control), 25mg/kg (test) Observation period : 12 week application GLP : / The substance (hydrochloride) was administered daily by gavage to 12 male and 12 female SPW Wistar rats for 12 weeks at a dose of 25 mg/kg/bw. A control grou","page":10,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - sub-chronic repeated dose toxicity {"dose":"A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day.","effect":"enylenediamine sulfate 15 No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion On the basis of the results of acute toxicity studies, A80 should be classified as ‘toxic’ (EC criteria). A80 does not show eye- or skin irritation at the ‘in-use concentration’ and was negative in a maximisation test. A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day. The in vitro and in vivo studies on percutaneous absorption are all inadequate; an assessment could not be done. The in vitro studies on mutagenicity are all inadequate; an assessment could not be done. 4. CONCLUSION The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: * complete physico-che","page":15,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_002"}
SCCS_vision_codex NOAEL =25 mg/kg bw rat oral 90 days NOAEL study {"citation":"Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dih","dose":"The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group.","effect":"for 90 days. Food consumption and body weight gain were normal. From the 11th to 13th week, orange coloured urine was observed and the frequency of this observation increased with the higher doses. No ophthalmoscopic and haematological changes, weight deviations and macroscopic changes of the organs were found. All histomorphological findings were not test substance dependent. The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group. The no-effect level (NOEL) was set at 25 mg/kg bw. Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dihydrochloride Purity : 99 % Batch no : / Dose levels : 5 ml/kg (control), 25mg/kg (test) Observation period : 12 week application GLP : / The substance (hydrochloride) was administered daily by gavage to 12 male and 12 female SPW Wistar rats for 12 weeks at a dose of 25 mg/kg/bw. A control grou","page":10,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_001"}
SCCS_vision_codex NOAEL =25 mg/kg bw/day rat - sub-chronic repeated dose toxicity {"dose":"A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day.","effect":"enylenediamine sulfate 15 No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion On the basis of the results of acute toxicity studies, A80 should be classified as ‘toxic’ (EC criteria). A80 does not show eye- or skin irritation at the ‘in-use concentration’ and was negative in a maximisation test. A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day. The in vitro and in vivo studies on percutaneous absorption are all inadequate; an assessment could not be done. The in vitro studies on mutagenicity are all inadequate; an assessment could not be done. 4. CONCLUSION The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: * complete physico-che","page":15,"pdf":"sccp_o_00b.pdf","row_type":"noael_study","study_id":"sccp_o_00b_noael_002"}
SCCS_vision_codex NOAEL =30 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 30","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30","page":20,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treat...","effect":".13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg/day human - developmental developmental toxicity {"citation":"Ref.: 30 3","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30 3.3.9. Toxicokinetics Taken from SCCP/1124/07 Bioavailability across the intestinal barrier Guideline: Not indicated Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II) Batch: 36/37 Purity: ~99.8% Concentration: 50 µM in HBSS buffer con","page":22,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"_____________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it wa","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_007"}
SCCS_vision_codex NOAEL =30 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 30","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30","page":20,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treat...","effect":".13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 30","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30","page":20,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treat...","effect":".13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg/day human - developmental developmental toxicity {"citation":"Ref.: 30 3","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30 3.3.9. Toxicokinetics Taken from SCCP/1124/07 Bioavailability across the intestinal barrier Guideline: Not indicated Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II) Batch: 36/37 Purity: ~99.8% Concentration: 50 µM in HBSS buffer con","page":22,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"_____________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it wa","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_007"}
SCCS_vision_codex NOAEL =30 mg/kg/day human - developmental developmental toxicity {"citation":"Ref.: 30 3","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30 3.3.9. Toxicokinetics Taken from SCCP/1124/07 Bioavailability across the intestinal barrier Guideline: Not indicated Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II) Batch: 36/37 Purity: ~99.8% Concentration: 50 µM in HBSS buffer con","page":22,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"_____________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it wa","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_007"}
SCCS_vision_codex NOAEL =30 mg/kg/day - - developmental developmental toxicity {"citation":"Ref.: 30","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30","page":20,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treat...","effect":".13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_006"}
SCCS_vision_codex NOAEL =30 mg/kg/day human - developmental developmental toxicity {"citation":"Ref.: 30 3","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30 3.3.9. Toxicokinetics Taken from SCCP/1124/07 Bioavailability across the intestinal barrier Guideline: Not indicated Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II) Batch: 36/37 Purity: ~99.8% Concentration: 50 µM in HBSS buffer con","page":22,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_005"}
SCCS_vision_codex NOAEL =30 mg/kg bw/d rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","effect":"_____________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it wa","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_007"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"olouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the r","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_010"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"r colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μ","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_011"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"olouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the r","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_010"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"olouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the r","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_010"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"r colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μ","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_011"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"r colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μ","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_011"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"olouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the r","page":23,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_010"}
SCCS_vision_codex NOAEL =35 mg/kg bw rat oral 28-day developmental toxicity {"dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","effect":"r colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μ","page":25,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_011"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Triplicates in two independent experiments Test substance: Hydroxyethyl-p-Phenylenediamine Sulfate (WR 23361) Solvent: Deionised water Batch: 36/37 Purity: 99.8 area% (by HPLC) Conce","page":16,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_004"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCP/1124/07 Bacterial Reverse Mutation Test","page":17,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_004"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Triplicates in two independent experiments Test substance: Hydroxyethyl-p-Phenylenediamine Sulfate (WR 23361) Solvent: Deionised water Batch: 36/37 Purity: 99.8 area% (by HPLC) Conce","page":16,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_004"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Triplicates in two independent experiments Test substance: Hydroxyethyl-p-Phenylenediamine Sulfate (WR 23361) Solvent: Deionised water Batch: 36/37 Purity: 99.8 area% (by HPLC) Conce","page":16,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_004"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCP/1124/07 Bacterial Reverse Mutation Test","page":17,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_004"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCP/1124/07 Bacterial Reverse Mutation Test","page":17,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_004"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Triplicates in two independent experiments Test substance: Hydroxyethyl-p-Phenylenediamine Sulfate (WR 23361) Solvent: Deionised water Batch: 36/37 Purity: 99.8 area% (by HPLC) Conce","page":16,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_004"}
SCCS_vision_codex NOAEL =55 mg/kg bw/day rat - 90 days genotoxicity {"citation":"Ref.: 25 3","dose":"effects were not dose-related.","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCP/1124/07 Bacterial Reverse Mutation Test","page":17,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_004"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose","page":15,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch:","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose","page":15,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose","page":15,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch:","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch:","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose","page":15,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch:","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_002"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat dermal 5 days NOAEL study {"dose":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period:","effect":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period: 26 September 1990 (first dosing) Three groups (5 male and 5 female rats) received oxytol-B-sulphate in a concentration of 0 (vehicle only), 62.5, 250 or 1000 mg/kg bw once a day on 5 days per week for 28 consecutive days. This dose-range was based on a preliminary study, in which a non- significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulphate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the tes","page":14,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_001"}
SCCS_vision_codex NOAEL =2000 mg/kg bw - dermal 5 days NOAEL study {"dose":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw.","effect":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulfate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the test","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_001"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat dermal 5 days NOAEL study {"dose":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period:","effect":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period: 26 September 1990 (first dosing) Three groups (5 male and 5 female rats) received oxytol-B-sulphate in a concentration of 0 (vehicle only), 62.5, 250 or 1000 mg/kg bw once a day on 5 days per week for 28 consecutive days. This dose-range was based on a preliminary study, in which a non- significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulphate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the tes","page":14,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_001"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat dermal 5 days NOAEL study {"dose":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period:","effect":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period: 26 September 1990 (first dosing) Three groups (5 male and 5 female rats) received oxytol-B-sulphate in a concentration of 0 (vehicle only), 62.5, 250 or 1000 mg/kg bw once a day on 5 days per week for 28 consecutive days. This dose-range was based on a preliminary study, in which a non- significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulphate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the tes","page":14,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_001"}
SCCS_vision_codex NOAEL =2000 mg/kg bw - dermal 5 days NOAEL study {"dose":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw.","effect":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulfate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the test","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_001"}
SCCS_vision_codex NOAEL =2000 mg/kg bw - dermal 5 days NOAEL study {"dose":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw.","effect":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulfate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the test","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_001"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat dermal 5 days NOAEL study {"dose":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period:","effect":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period: 26 September 1990 (first dosing) Three groups (5 male and 5 female rats) received oxytol-B-sulphate in a concentration of 0 (vehicle only), 62.5, 250 or 1000 mg/kg bw once a day on 5 days per week for 28 consecutive days. This dose-range was based on a preliminary study, in which a non- significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulphate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the tes","page":14,"pdf":"sccp_o_143.pdf","row_type":"noael_study","study_id":"sccp_o_143_noael_001"}
SCCS_vision_codex NOAEL =2000 mg/kg bw - dermal 5 days NOAEL study {"dose":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw.","effect":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulfate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the test","page":16,"pdf":"sccs_o_017.pdf","row_type":"noael_study","study_id":"sccs_o_017_noael_001"}
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =30 mg/kg bw/day Rat oral - developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac93e4b0a7c65d1bfcb6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23274/7/9/3?documentUUID=577718c6-0b5f-43c7-86b2-34fa156f9302; YEAR=1992; ORIGINAL_YEAR=1992; STUDY_GROUP=ECHA IUCLID:15820806:-:-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_47e18bc1259e0db3118dbc3536e00250
ToxValDB_ECHA_IUCLID NOAEL =35 mg/kg bw/day Rat oral subchronic; 90 days subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf71e4b0a7c65d1ce086; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23274/7/6/2?documentUUID=577718c6-0b5f-43c7-86b2-34fa156f9302; YEAR=1992; ORIGINAL_YEAR=1992; STUDY_GROUP=ECHA IUCLID:15844792: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_4c4c62b5fe4d9cae38639b87011b21f6
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =2.12 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15632698:-:--; 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_292090390a9a7c39d994f08b6ff7bb67
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 25 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 25 mg/kg bw rat oral 90 days - SOURCE_SUBDIR=sccp_o_00b; REPORT_TITLE=Opinion on Hydroxyethyl-p-phenylenediamine Sulfate COLIPA N° A80; OPINION_NUMBER=SCCP/0666/03; COMMITTEE=SCCP; REPORT_DATE=7 December 2004; VALUE_TEXT=25; DOSE=The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group.; EFFECT=for 90 days. Food consumption and body weight gain were normal. From the 11th to 13th week, orange coloured urine was observed and the frequency of this observation increased with the higher doses. No ophthalmoscopic and haematological changes, weight deviations and macroscopic changes of the organs were found. All histomorphological findings were not test substance dependent. The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group. The no-effect level (NOEL) was set at 25 mg/kg bw. Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dihydrochloride Purity : 99 % Batch no : / Dose levels : 5 ml/kg (control), 25mg/kg (test) Observation period : 12 week application GLP : / The substance (hydrochloride) was administered daily by gavage to 12 male and 12 female SPW Wistar rats for 12 weeks at a dose of 25 mg/kg/bw. A control grou; CITATION=Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dih; CITATION_NUMBERS=[5,408,1981,12]; REFERENCE=Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dih; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dih","dose":"The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group.","duration":"90 days","effect":"for 90 days. Food consumption and body weight gain were normal. From the 11th to 13th week, orange coloured urine was observed and the frequency of this observation increased with the higher doses. No ophthalmoscopic and haematological changes, weight deviations and macroscopic changes of the organs were found. All histomorphological findings were not test substance dependent. The mean GOT and GTP values of the highest dose group increased during week 13 in comparison with the control group. The no-effect level (NOEL) was set at 25 mg/kg bw. Ref.: 5 Guideline : OECD 408 (1981) Species/strain : Borchen Dawley rat Group size : 12 male and 12 female per test and control group Test substance : Hydroxyethyl-p-phenylenediamine dihydrochloride Purity : 99 % Batch no : / Dose levels : 5 ml/kg (control), 25mg/kg (test) Observation period : 12 week application GLP : / The substance (hydrochloride) was administered daily by gavage to 12 male and 12 female SPW Wistar rats for 12 weeks at a dose of 25 mg/kg/bw. A control grou","endpoint":"","ingredient":"Hydroxyethyl-p-phenylenediamine sulfate (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"25","page":10,"route":"oral","species":"rat","study_id":"sccp_o_00b_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2000 mg/kg bw rat dermal 5 days - SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=2000; DOSE=50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period:; EFFECT=50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period: 26 September 1990 (first dosing) Three groups (5 male and 5 female rats) received oxytol-B-sulphate in a concentration of 0 (vehicle only), 62.5, 250 or 1000 mg/kg bw once a day on 5 days per week for 28 consecutive days. This dose-range was based on a preliminary study, in which a non- significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulphate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the tes; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period:","duration":"5 days","effect":"50 and 1000 mg/kg bw Route: dermal Exposure: once a day on 5 days/week for 28 consecutive days GLP: in compliance Study period: 26 September 1990 (first dosing) Three groups (5 male and 5 female rats) received oxytol-B-sulphate in a concentration of 0 (vehicle only), 62.5, 250 or 1000 mg/kg bw once a day on 5 days per week for 28 consecutive days. This dose-range was based on a preliminary study, in which a non- significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulphate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the tes","endpoint":"","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":14,"route":"dermal","species":"rat","study_id":"sccp_o_143_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2000 mg/kg bw - dermal 5 days - SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=2000; DOSE=SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw.; EFFECT=SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulfate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the test; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw.","duration":"5 days","effect":"SCCS/1310/10, revision of 12.07.10 Opinion on hydroxyethyl-p-phenylenediamine sulfate __________________________________________________________________________________ 16 significant reduction in body weight and food consumption was observed at a dose of 2000 mg/kg bw. The NOEL of this study was 500 mg/kg bw. Oxytol-B-sulfate was dissolved in distilled water. Dermal administration was performed once a day on 5 days per week, on an area of the dorsal skin of about 5 cm x 6 cm, which is at least 10 % of the body surface. Hair of this region was clipped before first administration and then once a week. The test substance preparation was applied and spread using a plastic spatula. As far as necessary, some drops of distilled water were applied additionally to allow a distribution of the test","endpoint":"","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":16,"route":"dermal","species":"","study_id":"sccs_o_017_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.035 mg/kg bw rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 0.035; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...; EFFECT=ate __________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","duration":"","effect":"ate __________________________________________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice,","endpoint":"dermal absorption","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.035","page":25,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treat...; EFFECT=.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treat...","duration":"","effect":".13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90","endpoint":"dermal absorption","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":23,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg rat oral 28-day dermal absorption SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT== 30; DOSE=ULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of hum...; EFFECT=ULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NO; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"ULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of hum...","duration":"28-day","effect":"ULATION OF THE MARGIN OF SAFETY (hydroxyethyl-p-phenylenediamine sulfate) (oxidative hair dye) Calculation based on in vivo data (toxicokinetics study, reference 32) Maximum absorption through the skin A (μg/cm2) = 35 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.408 mg/kg No observed effect level (mg/kg) NOAEL = 30 mg/kg (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NO","endpoint":"dermal absorption","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg","noael_value":"= 30","page":23,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg bw/d rat oral - dermal absorption SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...; EFFECT=_____________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it wa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 k...","duration":"","effect":"_____________________________________________________ 25 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it wa","endpoint":"dermal absorption","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 30","page":25,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =30 mg/kg bw/d rat oral 28-day dermal absorption SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT== 30; DOSE=afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg...; EFFECT=afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOA; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg...","duration":"28-day","effect":"afety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Hydroxyethyl-p-phenylenediamine sulfate (oxidative conditions) Absorption through the skin (mean +1SD) A (μg/cm2) = 3.62µg/cm² Skin Area surface SAS (cm2) = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.10 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.035 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw/d (teratogenicity, oral, rat) Margin of Safety NOAEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOA","endpoint":"dermal absorption","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 30","page":25,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 30 mg/kg/day - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=30; DOSE=Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.; EFFECT=cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30; CITATION=Ref.: 30; CITATION_NUMBERS=[30]; REFERENCE=Ref.: 30; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 30","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","duration":"developmental","effect":"cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30","endpoint":"developmental toxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg/day","noael_value":"30","page":20,"route":"","species":"","study_id":"sccp_o_143_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 30 mg/kg/day rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=30; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=thyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the residual amount of material present in the skin at 72 hours. For the aqueous solution, the abs; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"thyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the residual amount of material present in the skin at 72 hours. For the aqueous solution, the abs","endpoint":"developmental toxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg/day","noael_value":"30","page":23,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 30 mg/kg/day human - developmental developmental toxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=30; DOSE=Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.; EFFECT=SCCS-rejected applicant NOAEL: cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30 3.3.9. Toxicokinetics Taken from SCCP/1124/07 Bioavailability across the intestinal barrier Guideline: Not indicated Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II) Batch: 36/37 Purity: ~99.8% Concentration: 50 µM in HBSS buffer con; CITATION=Ref.: 30 3; CITATION_NUMBERS=[30,3]; REFERENCE=Ref.: 30 3; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 30 3","dose":"Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: cted body weight and corrected body weight gain was not affected by the test item. Necropsy did not reveal any treatment-related effects. Early embryonic death and post- implantation loss were higher in the 70 mg/kg bw/day dose group as a consequence of maternal toxicity. Foetal body weight and placental weight were similar to control values. Sporadic external, visceral and skeletal alterations were observed, but these effects were not considered treatment-related. Conclusions Based on this teratogenicity study a NOAEL for maternal and developmental toxicity of 30 mg/kg/day was determined. No specific compound-related teratogenic effects were observed in this teratogenicity study. Ref.: 30 3.3.9. Toxicokinetics Taken from SCCP/1124/07 Bioavailability across the intestinal barrier Guideline: Not indicated Cells: Human intestinal epithelial cell line TC-7, a sub-clone of the Caco- 2 cell line Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II) Batch: 36/37 Purity: ~99.8% Concentration: 50 µM in HBSS buffer con","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg/day","noael_value":"30","page":22,"route":"","species":"human","study_id":"sccs_o_017_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 30 mg/kg/day rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=30; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=ethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the residual amount of material present in the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"ethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the residual amount of material present in the","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg/day","noael_value":"30","page":25,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 35 mg/kg bw rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=35; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=olouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"olouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μg/cm² with hydrogen peroxide, when considering the r","endpoint":"developmental toxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg bw","noael_value":"35","page":23,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 35 mg/kg bw rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=35; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=r colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μ; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"r colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without hydrogen peroxide or to 35 μ","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw","noael_value":"35","page":25,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw/day rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=250; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=EL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"EL / SED = 74 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed","endpoint":"developmental toxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw/day rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=250; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=roperties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"roperties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 1.5%. The stability of hydroxyethyl-p- phenylenediamine sulphate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed corresponds to 15 μg/cm² for the formulation without","endpoint":"developmental toxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw/day rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=250; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=AEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"AEL / SED = 857 3.3.14. Discussion Physico-chemical properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration.","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":25,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw/day rat oral 28-day developmental toxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=250; DOSE=The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;; EFFECT=l properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"The LD50 ranging from 80 to 150 mg/kg bw in male and female rats;","duration":"28-day","effect":"l properties Hydroxyethyl-p-phenylenediamine sulfate is used as an oxidative hair colouring agent. The intended maximum on-head concentration is 2%. The stability of hydroxyethyl-p- phenylenediamine sulfate in the marketed products is not reported. General toxicity The substance was considered to be moderately toxic. The LD50 ranging from 80 to 150 mg/kg bw in male and female rats; In mice, it was 90 mg/kg bw. Based on the local effects in a 28-day study, the NOAEL was set at 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects was set at 1000 mg/kg bw/day. In a 90-day study, the NOAEL was set at 35 mg/kg bw based on an increase in the AST and ALT activities in rats. The NOAEL for maternal and developmental toxicity was set at 30 mg/kg/day. No specific compound-related teratogenic effects were observed. No two generation reproduction study was submitted. Toxicokinetics Toxicokinetics were studied in rats in vivo after topical application and oral administration. After dermal application, the total amount absorbed c","endpoint":"developmental toxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":25,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 55 mg/kg bw/day rat - 90 days genotoxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=55; DOSE=effects were not dose-related.; EFFECT=effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Triplicates in two independent experiments Test substance: Hydroxyethyl-p-Phenylenediamine Sulfate (WR 23361) Solvent: Deionised water Batch: 36/37 Purity: 99.8 area% (by HPLC) Conce; CITATION=Ref.: 25 3; CITATION_NUMBERS=[25,3]; REFERENCE=Ref.: 25 3; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 25 3","dose":"effects were not dose-related.","duration":"90 days","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 Replicates: Triplicates in two independent experiments Test substance: Hydroxyethyl-p-Phenylenediamine Sulfate (WR 23361) Solvent: Deionised water Batch: 36/37 Purity: 99.8 area% (by HPLC) Conce","endpoint":"genotoxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"55","page":16,"route":"","species":"rat","study_id":"sccp_o_143_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 55 mg/kg bw/day rat - 90 days genotoxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=55; DOSE=effects were not dose-related.; EFFECT=effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCP/1124/07 Bacterial Reverse Mutation Test; CITATION=Ref.: 25 3; CITATION_NUMBERS=[25,3]; REFERENCE=Ref.: 25 3; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 25 3","dose":"effects were not dose-related.","duration":"90 days","effect":"effects were not dose-related. In the 55 mg/kg bw/day dose group, a test item-related and statistically and biologically significant increase in activity of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) was found in male and especially in female animals. Histopathology did not reveal dose-related lesions of the examined organs. Conclusion Hydroxyethyl-p-phenylenediamine sulfate induced an increase in the AST and ALT activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day for 90 days. The NOAEL in this study was 35 mg/kg bw. Ref.: 25 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCP/1124/07 Bacterial Reverse Mutation Test","endpoint":"genotoxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"55","page":17,"route":"","species":"rat","study_id":"sccs_o_017_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 25 mg/kg bw/day rat - sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_00b; REPORT_TITLE=Opinion on Hydroxyethyl-p-phenylenediamine Sulfate COLIPA N° A80; OPINION_NUMBER=SCCP/0666/03; COMMITTEE=SCCP; REPORT_DATE=7 December 2004; VALUE_TEXT=25; DOSE=A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day.; EFFECT=enylenediamine sulfate 15 No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion On the basis of the results of acute toxicity studies, A80 should be classified as ‘toxic’ (EC criteria). A80 does not show eye- or skin irritation at the ‘in-use concentration’ and was negative in a maximisation test. A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day. The in vitro and in vivo studies on percutaneous absorption are all inadequate; an assessment could not be done. The in vitro studies on mutagenicity are all inadequate; an assessment could not be done. 4. CONCLUSION The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: * complete physico-che; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"93841-25-9","citation":"","dose":"A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day.","duration":"sub-chronic","effect":"enylenediamine sulfate 15 No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion On the basis of the results of acute toxicity studies, A80 should be classified as ‘toxic’ (EC criteria). A80 does not show eye- or skin irritation at the ‘in-use concentration’ and was negative in a maximisation test. A sub-chronic study showed a NOEL of 25 mg/kg bw/day and the substance was not teratogenic in rats at 10 mg/kg bw/day. The in vitro and in vivo studies on percutaneous absorption are all inadequate; an assessment could not be done. The in vitro studies on mutagenicity are all inadequate; an assessment could not be done. 4. CONCLUSION The SCCNFP is of the opinion that the information submitted is inadequate to assess the safe use of the substance. Before any further consideration, the following information is required: * complete physico-che","endpoint":"repeated dose toxicity","ingredient":"Hydroxyethyl-p-phenylenediamine sulfate (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":15,"route":"","species":"rat","study_id":"sccp_o_00b_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=250; DOSE=No dose-related abnormalities with respect to ophthalmoscopy were observed.; EFFECT=icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose; CITATION=Ref.: 24 Comments The test substance solution was not tested for stability; CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24 Comments The test substance solution was not tested for stability; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","duration":"Sub-chronic","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose","endpoint":"repeated dose toxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":15,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_143; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCP/1124/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=250; DOSE=No dose-related abnormalities with respect to ophthalmoscopy were observed.; EFFECT=eed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose: 0 (vehicle only), 25, 35 and 55 mg/kg bw/day; CITATION=Ref.: 24 Comments The test substance solution was not tested for stability; CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24 Comments The test substance solution was not tested for stability; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","duration":"Sub-chronic","effect":"eed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose: 0 (vehicle only), 25, 35 and 55 mg/kg bw/day","endpoint":"repeated dose toxicity","ingredient":". “Before any further consideration, the following information is","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":15,"route":"oral","species":"rat","study_id":"sccp_o_143_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=250; DOSE=No dose-related abnormalities with respect to ophthalmoscopy were observed.; EFFECT=icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch:; CITATION=Ref.: 24 Comments The test substance solution was not tested for stability; CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24 Comments The test substance solution was not tested for stability; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","duration":"Sub-chronic","effect":"icant effect on body weight, organ weight and feed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch:","endpoint":"repeated dose toxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":16,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 250 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_017; REPORT_TITLE=OPINION ON Hydroxyethyl-p-phenylenediamine sulfate COLIPA n° A80; OPINION_NUMBER=SCCS/1310/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=12 July 2010; VALUE_TEXT=250; DOSE=No dose-related abnormalities with respect to ophthalmoscopy were observed.; EFFECT=eed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose: 0 (vehicle only), 25; CITATION=Ref.: 24 Comments The test substance solution was not tested for stability; CITATION_NUMBERS=[24]; REFERENCE=Ref.: 24 Comments The test substance solution was not tested for stability; DETAILS_JSON={"cas_number":"93841-25-9","citation":"Ref.: 24 Comments The test substance solution was not tested for stability","dose":"No dose-related abnormalities with respect to ophthalmoscopy were observed.","duration":"Sub-chronic","effect":"eed consumption was observed. No dose-related abnormalities with respect to ophthalmoscopy were observed. Chromodacryorrhoea (excessive secretion of coloured tears) was observed with increased dose. In the 1000 mg/kg bw/day dose group 3/10 animals showed acanthosis indicating local irritation. In one of the animals showing acanthosis also an ulcer was observed. No other histopathological alterations were found. Conclusions Based on the local effects in this study the NOAEL was 250 mg/kg bw/day for both sexes. The NOAEL for systemic effects is 1000 mg/kg bw/day. Ref.: 24 Comments The test substance solution was not tested for stability. 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCP/1124/07 Guideline: OECD 408 (1998) Species/strain: Rats / CRL:(WI) BR Wistar Group size: 20 animals (10 males and 10 females) per dose group Test substance: hydroxyethyl-p-phenylenediamine sulfate (Betoxol II), in 1% aqueous methylcellulose (as a suspension) Batch: 36/37 Purity: ~99.8% Dose: 0 (vehicle only), 25","endpoint":"repeated dose toxicity","ingredient":". Before any further consideration, the following information is required: *","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":16,"route":"oral","species":"rat","study_id":"sccs_o_017_noael_003"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier L8W90PN89R UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"L8W90PN89R"}
openFDA substances FDA UNII substance identifier L8W90PN89R UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"L8W90PN89R"}
openFDA substances FDA UNII substance identifier L8W90PN89R UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"L8W90PN89R"}
openFDA substances FDA UNII substance identifier L8W90PN89R UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H12N2O.H2O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"L8W90PN89R"}