NOAEL Studies Cosmetic Ingredient

2,5,6-TRIAMINO-4-PYRIMIDINOL SULFATE NOAEL Studies

CAS: 1603-02-7

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

Back to parent ingredient page
COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 50 mg/kg bw/day rat oral 90 day Subchronic SCCP; H. Schmid, K. Biedermann, H. Luetkemeier, K. Weber, 1995; Subchronic 13-week oral(gavage) toxicity study with 4-OH-2,5,6-triamino-pyrimidine (sulphate) in the rat, RCCProject No. 376255, Test Report, Itingen/CH, October 31, 1995
SCCNFP_vision_codex 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =200 mg/kg bw rat oral Subchronic repeated dose toxicity {"citation":"Ref.: 7 2","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown).","effect":"normal findings were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. Ref.: 7 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity Guideline : OECD 408 (1981) Species/strain : HanIbm: WIST rat Group size : 10 males + 10 females Test substance : 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch number : 67346 Purity : 100.4 % Dose levels : 0, 50, 200 and 1000 mg/kg bw by gavage Exposure period : at least 13 weeks, once daily, 7 days per week GLP : in compliance The test substa","page":7,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_001"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw rat - - dermal absorption {"citation":"Ref.: 10 2","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ned for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw in this study. Ref.: 10 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.2. Percutaneous absorption, distribution and elimination in vivo Guideline : EPA (1993) Species/strain : Rats, male, female, Sprague Dawley, SPF-quality Test substance : ring-labelled 14C-TRAP (1 mg/ml, specific activity 105 µCi/ml) Dose levels : 50 µl/cm² of a 0.075% of 2,5,6-Triamino-4-pyrimidol sulfate in a mixture for hair dyeing (with developer) on a total of 9 cm² per animal","page":11,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_003"}
SCCNFP_vision_codex NOAEL =200 mg/kg bw rat oral Subchronic repeated dose toxicity {"citation":"Ref.: 7 2","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown).","effect":"normal findings were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. Ref.: 7 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity Guideline : OECD 408 (1981) Species/strain : HanIbm: WIST rat Group size : 10 males + 10 females Test substance : 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch number : 67346 Purity : 100.4 % Dose levels : 0, 50, 200 and 1000 mg/kg bw by gavage Exposure period : at least 13 weeks, once daily, 7 days per week GLP : in compliance The test substa","page":7,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_001"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw rat - - dermal absorption {"citation":"Ref.: 10 2","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ned for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw in this study. Ref.: 10 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.2. Percutaneous absorption, distribution and elimination in vivo Guideline : EPA (1993) Species/strain : Rats, male, female, Sprague Dawley, SPF-quality Test substance : ring-labelled 14C-TRAP (1 mg/ml, specific activity 105 µCi/ml) Dose levels : 50 µl/cm² of a 0.075% of 2,5,6-Triamino-4-pyrimidol sulfate in a mixture for hair dyeing (with developer) on a total of 9 cm² per animal","page":11,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_003"}
SCCNFP_vision_codex NOAEL =200 mg/kg bw rat oral Subchronic repeated dose toxicity {"citation":"Ref.: 7 2","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown).","effect":"normal findings were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. Ref.: 7 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity Guideline : OECD 408 (1981) Species/strain : HanIbm: WIST rat Group size : 10 males + 10 females Test substance : 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch number : 67346 Purity : 100.4 % Dose levels : 0, 50, 200 and 1000 mg/kg bw by gavage Exposure period : at least 13 weeks, once daily, 7 days per week GLP : in compliance The test substa","page":7,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_001"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw rat - - dermal absorption {"citation":"Ref.: 10 2","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ned for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw in this study. Ref.: 10 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.2. Percutaneous absorption, distribution and elimination in vivo Guideline : EPA (1993) Species/strain : Rats, male, female, Sprague Dawley, SPF-quality Test substance : ring-labelled 14C-TRAP (1 mg/ml, specific activity 105 µCi/ml) Dose levels : 50 µl/cm² of a 0.075% of 2,5,6-Triamino-4-pyrimidol sulfate in a mixture for hair dyeing (with developer) on a total of 9 cm² per animal","page":11,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_003"}
SCCNFP_vision_codex NOAEL =200 mg/kg bw rat oral Subchronic repeated dose toxicity {"citation":"Ref.: 7 2","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown).","effect":"normal findings were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. Ref.: 7 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity Guideline : OECD 408 (1981) Species/strain : HanIbm: WIST rat Group size : 10 males + 10 females Test substance : 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch number : 67346 Purity : 100.4 % Dose levels : 0, 50, 200 and 1000 mg/kg bw by gavage Exposure period : at least 13 weeks, once daily, 7 days per week GLP : in compliance The test substa","page":7,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_001"}
SCCNFP_vision_codex NOAEL =1000 mg/kg bw rat - - dermal absorption {"citation":"Ref.: 10 2","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ned for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw in this study. Ref.: 10 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.2. Percutaneous absorption, distribution and elimination in vivo Guideline : EPA (1993) Species/strain : Rats, male, female, Sprague Dawley, SPF-quality Test substance : ring-labelled 14C-TRAP (1 mg/ml, specific activity 105 µCi/ml) Dose levels : 50 µl/cm² of a 0.075% of 2,5,6-Triamino-4-pyrimidol sulfate in a mixture for hair dyeing (with developer) on a total of 9 cm² per animal","page":11,"pdf":"out206_en.pdf","row_type":"noael_study","study_id":"out206_en_noael_003"}
SCCS_vision_codex 20 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 7 3","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).","effect":"gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0710/03 Guideline: OECD 408 (1981) Species/strain: HanIbm: WIST rat Group size: 10 males + 10 females Test substance: 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch: 67346 Purity: 100.4% Dose levels: 0, 50, 200 and 1000 mg/kg bw/day by gavage","page":13,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 10 3","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 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","page":18,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_003"}
SCCS_vision_codex NOAEL =0.83 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorpti...","effect":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rat oral 90-day dermal absorption {"dose":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Reten...","effect":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp...","effect":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_006"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 7 3","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).","effect":"gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0710/03 Guideline: OECD 408 (1981) Species/strain: HanIbm: WIST rat Group size: 10 males + 10 females Test substance: 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch: 67346 Purity: 100.4% Dose levels: 0, 50, 200 and 1000 mg/kg bw/day by gavage","page":13,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 10 3","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 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","page":18,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_003"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 7 3","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).","effect":"gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0710/03 Guideline: OECD 408 (1981) Species/strain: HanIbm: WIST rat Group size: 10 males + 10 females Test substance: 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch: 67346 Purity: 100.4% Dose levels: 0, 50, 200 and 1000 mg/kg bw/day by gavage","page":13,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 10 3","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 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","page":18,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_003"}
SCCS_vision_codex NOAEL =0.83 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorpti...","effect":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rat oral 90-day dermal absorption {"dose":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Reten...","effect":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp...","effect":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_006"}
SCCS_vision_codex NOAEL =0.83 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorpti...","effect":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rat oral 90-day dermal absorption {"dose":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Reten...","effect":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp...","effect":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_006"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 7 3","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).","effect":"gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0710/03 Guideline: OECD 408 (1981) Species/strain: HanIbm: WIST rat Group size: 10 males + 10 females Test substance: 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch: 67346 Purity: 100.4% Dose levels: 0, 50, 200 and 1000 mg/kg bw/day by gavage","page":13,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_001"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/day human - - NOAEL study {"citation":"Ref.: 10 3","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","effect":"ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 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","page":18,"pdf":"sccp_o_144.pdf","row_type":"noael_study","study_id":"sccp_o_144_noael_003"}
SCCS_vision_codex NOAEL =0.83 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorpti...","effect":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_004"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rat oral 90-day dermal absorption {"dose":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Reten...","effect":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 90-day dermal absorption {"dose":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp...","effect":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","page":20,"pdf":"sccs_o_185.pdf","row_type":"noael_study","study_id":"sccs_o_185_noael_006"}
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 1000 mg/kg bw rat - - dermal absorption SOURCE_SUBDIR=out206_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,5,6-TRIAMINO-4-PYRIMIDINOL SULFATE COLIPA n° A143; OPINION_NUMBER=SCCNFP/0710/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=1000; DOSE=Results The bedding material in the cages was discoloured orange in the treated group.; EFFECT=ned for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw in this study. Ref.: 10 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.2. Percutaneous absorption, distribution and elimination in vivo Guideline : EPA (1993) Species/strain : Rats, male, female, Sprague Dawley, SPF-quality Test substance : ring-labelled 14C-TRAP (1 mg/ml, specific activity 105 µCi/ml) Dose levels : 50 µl/cm² of a 0.075% of 2,5,6-Triamino-4-pyrimidol sulfate in a mixture for hair dyeing (with developer) on a total of 9 cm² per animal; CITATION=Ref.: 10 2; CITATION_NUMBERS=[10,2]; REFERENCE=Ref.: 10 2; DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 10 2","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","duration":"","effect":"ned for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw in this study. Ref.: 10 2.7. Toxicokinetics (incl. Percutaneous Absorption) 2.7.2. Percutaneous absorption, distribution and elimination in vivo Guideline : EPA (1993) Species/strain : Rats, male, female, Sprague Dawley, SPF-quality Test substance : ring-labelled 14C-TRAP (1 mg/ml, specific activity 105 µCi/ml) Dose levels : 50 µl/cm² of a 0.075% of 2,5,6-Triamino-4-pyrimidol sulfate in a mixture for hair dyeing (with developer) on a total of 9 cm² per animal","endpoint":"dermal absorption","ingredient":"4-Hydroxy-2,5,6-triaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":11,"route":"","species":"rat","study_id":"out206_en_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 200 mg/kg bw rat oral Subchronic repeated dose toxicity SOURCE_SUBDIR=out206_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,5,6-TRIAMINO-4-PYRIMIDINOL SULFATE COLIPA n° A143; OPINION_NUMBER=SCCNFP/0710/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=200; DOSE=A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown).; EFFECT=normal findings were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. Ref.: 7 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity Guideline : OECD 408 (1981) Species/strain : HanIbm: WIST rat Group size : 10 males + 10 females Test substance : 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch number : 67346 Purity : 100.4 % Dose levels : 0, 50, 200 and 1000 mg/kg bw by gavage Exposure period : at least 13 weeks, once daily, 7 days per week GLP : in compliance The test substa; CITATION=Ref.: 7 2; CITATION_NUMBERS=[7,2]; REFERENCE=Ref.: 7 2; DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 7 2","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown).","duration":"Subchronic","effect":"normal findings were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw (deep-yellow) and 1000 mg/kg bw (deep-brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. Ref.: 7 2.3.5 Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Subchronic oral toxicity Guideline : OECD 408 (1981) Species/strain : HanIbm: WIST rat Group size : 10 males + 10 females Test substance : 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch number : 67346 Purity : 100.4 % Dose levels : 0, 50, 200 and 1000 mg/kg bw by gavage Exposure period : at least 13 weeks, once daily, 7 days per week GLP : in compliance The test substa","endpoint":"repeated dose toxicity","ingredient":"4-Hydroxy-2,5,6-triaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":7,"route":"oral","species":"rat","study_id":"out206_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 200 mg/kg bw rabbit dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out206_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,5,6-TRIAMINO-4-PYRIMIDINOL SULFATE COLIPA n° A143; OPINION_NUMBER=SCCNFP/0710/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=200; DOSE=In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite.; EFFECT=elated effect. In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found (RBC, HP, HCT, MCV, MCH, reticulocyte count). Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw. Ref.: 8 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 1 male, 2 females Test substance : TRAP, a yellow solid Batch no : / Purity : / Dose : 0.5 ml of test article solution GLP : In compliance The dorsal fur was clipped, and the test article was dissolved in distilled; CITATION=Ref.: 8 2; CITATION_NUMBERS=[8,2]; REFERENCE=Ref.: 8 2; DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 8 2","dose":"In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite.","duration":"Sub-chronic","effect":"elated effect. In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found (RBC, HP, HCT, MCV, MCH, reticulocyte count). Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw. Ref.: 8 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 1 male, 2 females Test substance : TRAP, a yellow solid Batch no : / Purity : / Dose : 0.5 ml of test article solution GLP : In compliance The dorsal fur was clipped, and the test article was dissolved in distilled","endpoint":"repeated dose toxicity","ingredient":"4-Hydroxy-2,5,6-triaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":8,"route":"dermal","species":"rabbit","study_id":"out206_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 200 mg/kg bw rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=out206_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,5,6-TRIAMINO-4-PYRIMIDINOL SULFATE COLIPA n° A143; OPINION_NUMBER=SCCNFP/0710/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=200; DOSE=In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw: tubular basophilia and brownish pigment intratubular or in the pelvis.; EFFECT=710/03, final Evaluation and opinion on : 2,5,6-Triamino-4-pyrimidinol sulfate ____________________________________________________________________________________________ 18 2,5,6-Triamino-4-pyrimidinol sulfate was considered as non-irritant to rabbit skin. The substance was not a sensitizer in the concentration tested. In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose grou; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":"In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw: tubular basophilia and brownish pigment intratubular or in the pelvis.","duration":"subchronic","effect":"710/03, final Evaluation and opinion on : 2,5,6-Triamino-4-pyrimidinol sulfate ____________________________________________________________________________________________ 18 2,5,6-Triamino-4-pyrimidinol sulfate was considered as non-irritant to rabbit skin. The substance was not a sensitizer in the concentration tested. In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose grou","endpoint":"repeated dose toxicity","ingredient":"4-Hydroxy-2,5,6-triaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":18,"route":"oral","species":"rat","study_id":"out206_en_noael_004"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 200 mg/kg bw rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=out206_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,5,6-TRIAMINO-4-PYRIMIDINOL SULFATE COLIPA n° A143; OPINION_NUMBER=SCCNFP/0710/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=200; DOSE=In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite.; EFFECT=mg/kg bw. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw. In the teratogenicity study the limit dose 1000 mg/kg bw 2,5,6-Triamino-4-pyrimidinol sulfate exhibited no maternal and embryo/foetotoxicity. Percutaneous absorption : though the in vivo study is performed lege artis, it is unsuitable for the intended safety calculation, since a 33-fold lower dosage (0.075%) is applied than claimed (2.5%). Since it cannot be excluded that under use conditions higher percutaneous absorption rates occur, a worst case calculation is made, assuming 10; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":"In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite.","duration":"subchronic","effect":"mg/kg bw. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw (both sexes) and 200 mg/kg bw (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw. In the teratogenicity study the limit dose 1000 mg/kg bw 2,5,6-Triamino-4-pyrimidinol sulfate exhibited no maternal and embryo/foetotoxicity. Percutaneous absorption : though the in vivo study is performed lege artis, it is unsuitable for the intended safety calculation, since a 33-fold lower dosage (0.075%) is applied than claimed (2.5%). Since it cannot be excluded that under use conditions higher percutaneous absorption rates occur, a worst case calculation is made, assuming 10","endpoint":"repeated dose toxicity","ingredient":"4-Hydroxy-2,5,6-triaminopyrimidine sulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":18,"route":"oral","species":"rat","study_id":"out206_en_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/day human - - - SOURCE_SUBDIR=sccp_o_144; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate COLIPA n° A143; OPINION_NUMBER=SCCP/1122/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=1000; DOSE=Results The bedding material in the cages was discoloured orange in the treated group.; EFFECT=ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 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; CITATION=Ref.: 10 3; CITATION_NUMBERS=[10,3]; REFERENCE=Ref.: 10 3; DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 10 3","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","duration":"","effect":"ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 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","endpoint":"","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":18,"route":"","species":"human","study_id":"sccp_o_144_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_185; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143); OPINION_NUMBER=SCCS/1561/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=200; DOSE=A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).; EFFECT=gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 (Submission I); CITATION=Ref.: 7 (Submission I); CITATION_NUMBERS=[7]; REFERENCE=Ref.: 7 (Submission I); DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 7 (Submission I)","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).","duration":"","effect":"gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 (Submission I)","endpoint":"","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":13,"route":"","species":"","study_id":"sccs_o_185_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_185; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143); OPINION_NUMBER=SCCS/1561/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=1000; DOSE=Results The bedding material in the cages was discoloured orange in the treated group.; EFFECT=ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 (Submission I); CITATION=Ref.: 10 (Submission I); CITATION_NUMBERS=[10]; REFERENCE=Ref.: 10 (Submission I); DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 10 (Submission I)","dose":"Results The bedding material in the cages was discoloured orange in the treated group.","duration":"","effect":"ed for skeletal defects and variations of the ossification process by Alizarin Red staining and one half was evaluated for visceral alterations. Results The bedding material in the cages was discoloured orange in the treated group. No maternal toxicity was found. No substance-related changes of reproduction data (number of implantations, resorptions and foetuses, foetal weight and external abnormalities) was noted. No substance-related changes in the incidence of visceral and skeletal abnormalities was found. The NOAEL of maternal and embryo/foetotoxicity was 1000 mg/kg bw/day in this study. Ref.: 10 (Submission I)","endpoint":"","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":19,"route":"","species":"","study_id":"sccs_o_185_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.83 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_185; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143); OPINION_NUMBER=SCCS/1561/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT== 0.83; DOSE=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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorpti...; EFFECT=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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorpti...","duration":"90-day","effect":"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 (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","endpoint":"dermal absorption","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.83","page":20,"route":"oral","species":"rat","study_id":"sccs_o_185_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =200 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_185; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143); OPINION_NUMBER=SCCS/1561/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT== 200; DOSE=.3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Reten...; EFFECT=.3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Reten...","duration":"90-day","effect":".3.12 Special investigations No data submitted 3.3.13 Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","endpoint":"dermal absorption","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 200","page":20,"route":"oral","species":"rat","study_id":"sccs_o_185_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =100 mg/kg bw/d rat oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_185; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143); OPINION_NUMBER=SCCS/1561/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT==100; DOSE=the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp...; EFFECT=the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp...","duration":"90-day","effect":"the MoS) CALCULATION OF THE MARGIN OF SAFETY (2,5,6-triamino-4-pyrimidinol sulfate) (oxidative) Amount of formulation applied A (g/day) = 100 g Concentration on head of the ingredient C (%) = 0.5% Dermal absorption per treatment DAp (%) = 100% Retention factor RF = 0.1 Typical body weight of human = 60 kg Systemic exposure dose (SED) A x C x DAp x RF/60 = 0.83 mg/kg bw/d No observed adverse effect level (mg/kg) NOAEL = 200 mg/kg bw/d (90-day, oral, rat) Bioavailability* 50% =100 mg/kg bw/d Margin of Safety NOAEL / SED = 120 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation. 3.3.14 Discussion","endpoint":"dermal absorption","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"=100","page":20,"route":"oral","species":"rat","study_id":"sccs_o_185_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 200 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_144; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate COLIPA n° A143; OPINION_NUMBER=SCCP/1122/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=200; DOSE=In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite.; EFFECT=ffect. In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found (RBC, HP, HCT, MCV, MCH, reticulocyte count). Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: TA1535, TA1537, TA98, TA100 and TA102 Replicates: Triplicates in four independent experiments Test substance: 2,5,6-Triamino-4-Pyrimidinol Sulfate (TRAP) Solvent: The test item was mixed with sodium sulfite (5:1) and the mixture was dissolved in deionised; CITATION=Ref.: 8 3; CITATION_NUMBERS=[8,3]; REFERENCE=Ref.: 8 3; DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 8 3","dose":"In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite.","duration":"Chronic","effect":"ffect. In all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found (RBC, HP, HCT, MCV, MCH, reticulocyte count). Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: TA1535, TA1537, TA98, TA100 and TA102 Replicates: Triplicates in four independent experiments Test substance: 2,5,6-Triamino-4-Pyrimidinol Sulfate (TRAP) Solvent: The test item was mixed with sodium sulfite (5:1) and the mixture was dissolved in deionised","endpoint":"genotoxicity","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":14,"route":"","species":"","study_id":"sccp_o_144_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 200 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_185; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143); OPINION_NUMBER=SCCS/1561/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=200; DOSE=In all dose groups, urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females), which may be related to the substance or a metabolite.; EFFECT=ect. In all dose groups, urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females), which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found (RBC, HP, HCT, MCV, MCH, reticulocyte count). Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. Ref.: 8 (Submission I) 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/1122/07, but modified Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: Triplicates in four independent experiments; CITATION=Ref.: 8 (Submission I) 3; CITATION_NUMBERS=[8,3]; REFERENCE=Ref.: 8 (Submission I) 3; DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 8 (Submission I) 3","dose":"In all dose groups, urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females), which may be related to the substance or a metabolite.","duration":"Chronic","effect":"ect. In all dose groups, urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females), which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found (RBC, HP, HCT, MCV, MCH, reticulocyte count). Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. Ref.: 8 (Submission I) 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/1122/07, but modified Bacterial gene mutation assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: Triplicates in four independent experiments","endpoint":"genotoxicity","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":14,"route":"","species":"","study_id":"sccs_o_185_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_144; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate COLIPA n° A143; OPINION_NUMBER=SCCP/1122/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=200; DOSE=A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).; EFFECT=gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0710/03 Guideline: OECD 408 (1981) Species/strain: HanIbm: WIST rat Group size: 10 males + 10 females Test substance: 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch: 67346 Purity: 100.4% Dose levels: 0, 50, 200 and 1000 mg/kg bw/day by gavage; CITATION=Ref.: 7 3; CITATION_NUMBERS=[7,3]; REFERENCE=Ref.: 7 3; DETAILS_JSON={"cas_number":"1603-02-7","citation":"Ref.: 7 3","dose":"A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown).","duration":"Sub-chronic","effect":"gs were noted at ophthalmoscopy. No relevant changes were found in haematology, clinical biochemistry, absolute and relative organ weights. A discoloration of the urine was observed in the dose groups 200 mg/kg bw/day (deep-yellow) and 1000 mg/kg bw/day (deep- brown). Discoloration or discoloured foci were observed in some organs in all test substance treated groups. 2 females of the 1000 mg/kg bw/day group had abnormalities of the kidneys: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. Ref.: 7 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Taken from SCCNFP/0710/03 Guideline: OECD 408 (1981) Species/strain: HanIbm: WIST rat Group size: 10 males + 10 females Test substance: 4-OH-2,5,6-triamino-pyrimidine sulphate homogenized in corn oil Batch: 67346 Purity: 100.4% Dose levels: 0, 50, 200 and 1000 mg/kg bw/day by gavage","endpoint":"repeated dose toxicity","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":13,"route":"oral","species":"rat","study_id":"sccp_o_144_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_144; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate COLIPA n° A143; OPINION_NUMBER=SCCP/1122/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=200; DOSE=General toxicity In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw/day: tubular basophilia and brownish pigment intratubular or in the pelvis.; EFFECT=on 2,5,6-triamino-4-pyrimidinol sulfate 19 suitable antioxidant without any additional explanation. The reported solubility data lack accuracy and are indefinite in relation to pH. Calculated values of Log Pow cannot be accepted as an estimate of the true physical constant without justification. General toxicity In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw/day: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":"General toxicity In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw/day: tubular basophilia and brownish pigment intratubular or in the pelvis.","duration":"subchronic","effect":"on 2,5,6-triamino-4-pyrimidinol sulfate 19 suitable antioxidant without any additional explanation. The reported solubility data lack accuracy and are indefinite in relation to pH. Calculated values of Log Pow cannot be accepted as an estimate of the true physical constant without justification. General toxicity In the repeated dose oral toxicity in rats study abnormalities of the kidneys were noted in the dose group 1000 mg/kg bw/day: tubular basophilia and brownish pigment intratubular or in the pelvis. The NOAEL is 200 mg/kg bw/day. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highe","endpoint":"repeated dose toxicity","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":19,"route":"oral","species":"rat","study_id":"sccp_o_144_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_144; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate COLIPA n° A143; OPINION_NUMBER=SCCP/1122/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=30 September 2008; VALUE_TEXT=200; DOSE=In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite.; EFFECT=y. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. In the teratogenicity study the limit dose 1000 mg/kg bw/day 2,5,6-Triamino-4-pyrimidinol sulfate exhibited no maternal and embryo/foetotoxicity. Irritation / Sensitisation 2,5,6-Triamino-4-pyrimidinol sulfate was considered as non-irritant to rabbit skin. The substance was not a sensitizer in the concentration tested. However, the study is considered inadequate as the concentrations tested were too low. Dermal absorption Though the in vivo study is performed lege artis, i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":"In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite.","duration":"subchronic","effect":"y. In the study on subchronic oral toxicity in rats in all dose groups urine discoloration was observed, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. In the teratogenicity study the limit dose 1000 mg/kg bw/day 2,5,6-Triamino-4-pyrimidinol sulfate exhibited no maternal and embryo/foetotoxicity. Irritation / Sensitisation 2,5,6-Triamino-4-pyrimidinol sulfate was considered as non-irritant to rabbit skin. The substance was not a sensitizer in the concentration tested. However, the study is considered inadequate as the concentrations tested were too low. Dermal absorption Though the in vivo study is performed lege artis, i","endpoint":"repeated dose toxicity","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":19,"route":"oral","species":"rat","study_id":"sccp_o_144_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_185; REPORT_TITLE=OPINION ON 2,5,6-Triamino-4-pyrimidinol sulfate (Colipa No. A143); OPINION_NUMBER=SCCS/1561/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=200; DOSE=In the study on subchronic oral toxicity in rats urine, discoloration was observed in all dose groups, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite.; EFFECT=. In the study on subchronic oral toxicity in rats urine, discoloration was observed in all dose groups, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. In the teratogenicity study, the limit dose 1000 mg/kg bw/day 2,5,6-Triamino-4-pyrimidinol sulfate exhibited no maternal and embryo/foetotoxicity. Irritation / Sensitisation 2,5,6-Triamino-4-pyrimidinol sulfate was considered as non-irritant to rabbit skin and eye. The substance was not a sensitiser in the concentration tested. However, the study is considered inadequate as the concentrations tested were too low. Dermal absorption Though the in vivo study is performed lege; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1603-02-7","citation":"","dose":"In the study on subchronic oral toxicity in rats urine, discoloration was observed in all dose groups, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite.","duration":"subchronic","effect":". In the study on subchronic oral toxicity in rats urine, discoloration was observed in all dose groups, accompanied by turbidity at 1000 mg/kg bw/day (both sexes) and 200 mg/kg bw/day (females) which may be related to the substance or a metabolite. At the highest dose some significant changes of biochemical and haematological parameters were found. Organ weight changes (kidney) and brownish pigment deposition associated with epithelial degeneration in kidney and rectum were confined to the highest dose group. The NOAEL is considered to be 200 mg/kg bw/day. In the teratogenicity study, the limit dose 1000 mg/kg bw/day 2,5,6-Triamino-4-pyrimidinol sulfate exhibited no maternal and embryo/foetotoxicity. Irritation / Sensitisation 2,5,6-Triamino-4-pyrimidinol sulfate was considered as non-irritant to rabbit skin and eye. The substance was not a sensitiser in the concentration tested. However, the study is considered inadequate as the concentrations tested were too low. Dermal absorption Though the in vivo study is performed lege","endpoint":"repeated dose toxicity","ingredient":"2,5,6-Triamino-4-pyrimidinol sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":21,"route":"oral","species":"rat","study_id":"sccs_o_185_noael_007"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier T3YK834X4U UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H7N5O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T3YK834X4U"}
openFDA substances FDA UNII substance identifier T3YK834X4U UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H7N5O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T3YK834X4U"}
openFDA substances FDA UNII substance identifier T3YK834X4U UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H7N5O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T3YK834X4U"}
openFDA substances FDA UNII substance identifier T3YK834X4U UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H7N5O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T3YK834X4U"}