NOAEL Studies Cosmetic Ingredient

2,6-Dimethoxy-3,5-Pyridinediamine HCl NOAEL Studies

INCI: 2,6-DIMETHOXY-3,5-PYRIDINEDIAMINE HCL

CAS: 56216-28-5

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

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COSMOS_DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 15 mg/kg bw/day rat oral 90 day Subchronic SCCP; Jones, J. R.; Pyridinblau I / OEDC 408 90-day oral toxicity study in the rat; SAFEPHARM;09.04.1986
COSMOS_DB NOAEL 5 mg/kg bw/day rat oral 90 day Subchronic SCCP; Jones, J. R.; Pyridinblau I / OEDC 408 90-day oral toxicity study in the rat; SAFEPHARM;09.04.1986
NTP_ICE_skin_sensitization 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization EC3 6.9 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13079; Record_ID=skin_sensitization_invivo_3074; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID10892438; Assay=LLNA; Endpoint=EC3; Response=6.9; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID10892438
SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =45 mg/kg bw - - - NOAEL study {"citation":"Ref.: 33 3","dose":"During treatment all treated females had blue discoloured urine (due to the test substance).","effect":"rin Red staining and one third was evaluated for visceral imperfections (organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data","page":19,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg human dermal 90 day dermal absorption {"dose":"Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"CULATION OF THE MARGIN OF SAFETY (2,6-Dimethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irrita","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_003"}
SCCS_vision_codex NOAEL =10 mg/kg bw rabbit dermal 90 day dermal absorption {"dose":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_007"}
SCCS_vision_codex NOAEL =45 mg/kg bw - - - NOAEL study {"citation":"Ref.: 33 3","dose":"During treatment all treated females had blue discoloured urine (due to the test substance).","effect":"rin Red staining and one third was evaluated for visceral imperfections (organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data","page":19,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg human dermal 90 day dermal absorption {"dose":"Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"CULATION OF THE MARGIN OF SAFETY (2,6-Dimethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irrita","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_003"}
SCCS_vision_codex NOAEL =10 mg/kg bw rabbit dermal 90 day dermal absorption {"dose":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_007"}
SCCS_vision_codex NOAEL =45 mg/kg bw - - - NOAEL study {"citation":"Ref.: 33 3","dose":"During treatment all treated females had blue discoloured urine (due to the test substance).","effect":"rin Red staining and one third was evaluated for visceral imperfections (organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data","page":19,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg human dermal 90 day dermal absorption {"dose":"Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"CULATION OF THE MARGIN OF SAFETY (2,6-Dimethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irrita","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_003"}
SCCS_vision_codex NOAEL =10 mg/kg bw rabbit dermal 90 day dermal absorption {"dose":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_007"}
SCCS_vision_codex NOAEL =45 mg/kg bw - - - NOAEL study {"citation":"Ref.: 33 3","dose":"During treatment all treated females had blue discoloured urine (due to the test substance).","effect":"rin Red staining and one third was evaluated for visceral imperfections (organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data","page":19,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_001"}
SCCS_vision_codex NOAEL =5 mg/kg human dermal 90 day dermal absorption {"dose":"Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"CULATION OF THE MARGIN OF SAFETY (2,6-Dimethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irrita","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_003"}
SCCS_vision_codex NOAEL =10 mg/kg bw rabbit dermal 90 day dermal absorption {"dose":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","effect":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.","page":20,"pdf":"sccp_o_030.pdf","row_type":"noael_study","study_id":"sccp_o_030_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 45 mg/kg bw - - - - SOURCE_SUBDIR=sccp_o_030; REPORT_TITLE=Opinion on 2,6-Dimethoxy-3,5-pyridinediamine HCl COLIPA N° A101; OPINION_NUMBER=SCCP/0908/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 September 2005; VALUE_TEXT=45; DOSE=During treatment all treated females had blue discoloured urine (due to the test substance).; EFFECT=rin Red staining and one third was evaluated for visceral imperfections (organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data; CITATION=Ref.: 33 3; CITATION_NUMBERS=[33,3]; REFERENCE=Ref.: 33 3; DETAILS_JSON={"cas_number":"56216-28-5","citation":"Ref.: 33 3","dose":"During treatment all treated females had blue discoloured urine (due to the test substance).","duration":"","effect":"rin Red staining and one third was evaluated for visceral imperfections (organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data","endpoint":"","ingredient":"2,6-Dimethoxy-3,5-pyridinediamine HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"45","page":19,"route":"","species":"","study_id":"sccp_o_030_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 45 mg/kg bw - - - - SOURCE_SUBDIR=sccp_o_030; REPORT_TITLE=Opinion on 2,6-Dimethoxy-3,5-pyridinediamine HCl COLIPA N° A101; OPINION_NUMBER=SCCP/0908/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 September 2005; VALUE_TEXT=45; DOSE=During treatment all treated females had blue discoloured urine (due to the test substance).; EFFECT=(organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data; CITATION=Ref.: 33 3; CITATION_NUMBERS=[33,3]; REFERENCE=Ref.: 33 3; DETAILS_JSON={"cas_number":"56216-28-5","citation":"Ref.: 33 3","dose":"During treatment all treated females had blue discoloured urine (due to the test substance).","duration":"","effect":"(organic defects). No animal died during the study. During treatment all treated females had blue discoloured urine (due to the test substance). The high dose females showed slightly increased activity and exhibited rough haircoat. Food consumption and body weight gain were significantly reduced in the high dose group over the entire gestation period and at 10 and 25 mg/kg bw during treatment. No irreversible structural changes were found. The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. Remark The test substance has limited stability in water. Ref.: 33 3.3.9. Toxicokinetics No data 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data","endpoint":"","ingredient":"2,6-Dimethoxy-3,5-pyridinediamine HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"45","page":19,"route":"","species":"","study_id":"sccp_o_030_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =5 mg/kg human dermal 90 day dermal absorption SOURCE_SUBDIR=sccp_o_030; REPORT_TITLE=Opinion on 2,6-Dimethoxy-3,5-pyridinediamine HCl COLIPA N° A101; OPINION_NUMBER=SCCP/0908/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 September 2005; VALUE_TEXT== 5; DOSE=Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.; EFFECT=CULATION OF THE MARGIN OF SAFETY (2,6-Dimethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irrita; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"56216-28-5","citation":"","dose":"Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","duration":"90 day","effect":"CULATION OF THE MARGIN OF SAFETY (2,6-Dimethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irrita","endpoint":"dermal absorption","ingredient":"2,6-Dimethoxy-3,5-pyridinediamine HCl","loael_value":"","noael_unit":"mg/kg","noael_value":"= 5","page":20,"route":"dermal","species":"human","study_id":"sccp_o_030_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =5 mg/kg human dermal 90 day dermal absorption SOURCE_SUBDIR=sccp_o_030; REPORT_TITLE=Opinion on 2,6-Dimethoxy-3,5-pyridinediamine HCl COLIPA N° A101; OPINION_NUMBER=SCCP/0908/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 September 2005; VALUE_TEXT== 5; DOSE=Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.; EFFECT=ethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin ir; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"56216-28-5","citation":"","dose":"Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","duration":"90 day","effect":"ethoxy-3,5-pyridinediamine HCl) (Oxidative/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin ir","endpoint":"dermal absorption","ingredient":"2,6-Dimethoxy-3,5-pyridinediamine HCl","loael_value":"","noael_unit":"mg/kg","noael_value":"= 5","page":20,"route":"dermal","species":"human","study_id":"sccp_o_030_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =5 mg/kg human dermal 90 day dermal absorption SOURCE_SUBDIR=sccp_o_030; REPORT_TITLE=Opinion on 2,6-Dimethoxy-3,5-pyridinediamine HCl COLIPA N° A101; OPINION_NUMBER=SCCP/0908/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 September 2005; VALUE_TEXT== 5; DOSE=Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.; EFFECT=/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test con; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"56216-28-5","citation":"","dose":"Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","duration":"90 day","effect":"/permanent) The maximum concentration of 0.5 % of 2,6-Dimethoxy-3,5-pyridinediamine HCl is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 0.25 %. Maximum amount of ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test con","endpoint":"dermal absorption","ingredient":"2,6-Dimethoxy-3,5-pyridinediamine HCl","loael_value":"","noael_unit":"mg/kg","noael_value":"= 5","page":20,"route":"dermal","species":"human","study_id":"sccp_o_030_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 45 mg/kg bw rabbit dermal 90 day dermal absorption SOURCE_SUBDIR=sccp_o_030; REPORT_TITLE=Opinion on 2,6-Dimethoxy-3,5-pyridinediamine HCl COLIPA N° A101; OPINION_NUMBER=SCCP/0908/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 September 2005; VALUE_TEXT=45; DOSE=f ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.; EFFECT=f ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"56216-28-5","citation":"","dose":"f ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","duration":"90 day","effect":"f ingredient applied I (mg) = 250 Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.","endpoint":"dermal absorption","ingredient":"2,6-Dimethoxy-3,5-pyridinediamine HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"45","page":20,"route":"dermal","species":"rabbit","study_id":"sccp_o_030_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 10 mg/kg bw rabbit dermal 90 day dermal absorption SOURCE_SUBDIR=sccp_o_030; REPORT_TITLE=Opinion on 2,6-Dimethoxy-3,5-pyridinediamine HCl COLIPA N° A101; OPINION_NUMBER=SCCP/0908/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=20 September 2005; VALUE_TEXT=10; DOSE== 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.; EFFECT== 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"56216-28-5","citation":"","dose":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14.","duration":"90 day","effect":"= 60 kg Maximum absorption through the skin A (%) = 0.37 Dermal absorption per treatment I x A = 0.925 mg Systemic exposure dose (SED) I x A/60 = 0.015 No observed adverse effect level (mg/kg) NOAEL = 5 mg/kg Margin of Safety NOAEL / SED = 330 3.3.14. Discussion 2,6-dimethoxy-3,5-pyridinediamine HCL is used as a precursor in oxidative hair dye formulations at a maximum on-head concentration of 0.25 %. Toxicity The NOAEL of embryo/foetotoxicity was 45 mg/kg bw, for maternal toxicity no NOAEL was determined since even at the lowest dose of 10 mg/kg bw food consumption and body weight gain was decreased. In a 90 day-study the dose level without adverse effects was 5 mg/kg bw. Irritation No skin irritating properties were noted at test concentrations of 3 % in guinea pigs and with the undiluted product in rabbits. No eye irritant effects were noted in guinea pigs at 3 %.","endpoint":"dermal absorption","ingredient":"2,6-Dimethoxy-3,5-pyridinediamine HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"10","page":20,"route":"dermal","species":"rabbit","study_id":"sccp_o_030_noael_007"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier H109UIY001 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H11N3O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H109UIY001"}
openFDA substances FDA UNII substance identifier H109UIY001 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H11N3O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H109UIY001"}
openFDA substances FDA UNII substance identifier H109UIY001 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H11N3O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H109UIY001"}
openFDA substances FDA UNII substance identifier H109UIY001 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H11N3O2.2ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H109UIY001"}