NOAEL Studies Cosmetic Ingredient

HC Violet No. 1 NOAEL Studies

INCI: HC VIOLET NO. 1

CAS: 82576-75-8

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

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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 50 mg/kg bw/day rat oral 90 day Subchronic SCCP; S.A. Brownlie. IMEXINE FAA. 13 week oral toxicity study in the rat. ToxicolLaboratories Limited, Report N° LRL/21/93, 1994
SCCS_vision_codex 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =800 mg/kg bw/day rat oral - NOAEL study {"citation":"Ref.: 16 3","dose":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.","effect":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 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","page":25,"pdf":"sccp_o_063.pdf","row_type":"noael_study","study_id":"sccp_o_063_noael_001"}
SCCS_vision_codex NOAEL =800 mg/kg bw/day rat oral - NOAEL study {"citation":"Ref.: 16 3","dose":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.","effect":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 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","page":25,"pdf":"sccp_o_063.pdf","row_type":"noael_study","study_id":"sccp_o_063_noael_001"}
SCCS_vision_codex NOAEL =800 mg/kg bw/day rat oral - NOAEL study {"citation":"Ref.: 16 3","dose":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.","effect":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 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","page":25,"pdf":"sccp_o_063.pdf","row_type":"noael_study","study_id":"sccp_o_063_noael_001"}
SCCS_vision_codex NOAEL =800 mg/kg bw/day rat oral - NOAEL study {"citation":"Ref.: 16 3","dose":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.","effect":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 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","page":25,"pdf":"sccp_o_063.pdf","row_type":"noael_study","study_id":"sccp_o_063_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 800 mg/kg bw/day rat oral - - SOURCE_SUBDIR=sccp_o_063; REPORT_TITLE=Opinion on HC Violet n° 1 COLIPA N° B66; OPINION_NUMBER=SCCP/1025/06; COMMITTEE=Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers (SCCNFP); REPORT_DATE=20 June 2006; VALUE_TEXT=800; DOSE=ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.; EFFECT=ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"82576-75-8","citation":"Ref.: 16 3","dose":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.","duration":"","effect":"ion Oral administration of Imexine FAA to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted","endpoint":"","ingredient":"HC Violet n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"800","page":25,"route":"oral","species":"rat","study_id":"sccp_o_063_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 800 mg/kg bw/day - - - - SOURCE_SUBDIR=sccp_o_063; REPORT_TITLE=Opinion on HC Violet n° 1 COLIPA N° B66; OPINION_NUMBER=SCCP/1025/06; COMMITTEE=Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers (SCCNFP); REPORT_DATE=20 June 2006; VALUE_TEXT=800; DOSE=during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.; EFFECT=during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"82576-75-8","citation":"Ref.: 16 3","dose":"during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period.","duration":"","effect":"during organogenesis induced maternal toxicity at 800 mg/kg bw/day, characterised by a reduction of bodyweight gain and food consumption throughout the dosing period. At 200 and 50 mg/kg bw/day, there was no evidence of maternal toxicity. Red coloured urine and red staining of the tail and fur was observed in all treated groups. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered. The NOAEL of embryo/foetotoxicity is 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. Ref.: 16 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted","endpoint":"","ingredient":"HC Violet n° 1 (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"800","page":25,"route":"","species":"","study_id":"sccp_o_063_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 800 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_063; REPORT_TITLE=Opinion on HC Violet n° 1 COLIPA N° B66; OPINION_NUMBER=SCCP/1025/06; COMMITTEE=Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers (SCCNFP); REPORT_DATE=20 June 2006; VALUE_TEXT=800; DOSE=General toxicity In an acute oral toxicity study in rats the maximum non lethal dose of the test item was >2000 mg/kg bw.; LOAEL_VALUE=50 mg/kg bw/d; EFFECT=osation. The nitrosamine content in HC Violet n° 1 is not reported. No data are available on the stability in hair dye formulations. General toxicity In an acute oral toxicity study in rats the maximum non lethal dose of the test item was >2000 mg/kg bw. In an oral subchronic toxicity in rats, the LOAEL is considered being at 50 mg/kg bw/d due to the change in kidney weight in this group. Oral administration of HC Violet n° 1 to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered, the NOAEL of embryotoxicity is 800 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"82576-75-8","citation":"","dose":"General toxicity In an acute oral toxicity study in rats the maximum non lethal dose of the test item was >2000 mg/kg bw.","duration":"subchronic","effect":"osation. The nitrosamine content in HC Violet n° 1 is not reported. No data are available on the stability in hair dye formulations. General toxicity In an acute oral toxicity study in rats the maximum non lethal dose of the test item was >2000 mg/kg bw. In an oral subchronic toxicity in rats, the LOAEL is considered being at 50 mg/kg bw/d due to the change in kidney weight in this group. Oral administration of HC Violet n° 1 to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered, the NOAEL of embryotoxicity is 800 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"HC Violet n° 1 (INCI name)","loael_value":"50 mg/kg bw/d","noael_unit":"mg/kg bw/day","noael_value":"800","page":26,"route":"oral","species":"rat","study_id":"sccp_o_063_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 800 mg/kg bw/d rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_063; REPORT_TITLE=Opinion on HC Violet n° 1 COLIPA N° B66; OPINION_NUMBER=SCCP/1025/06; COMMITTEE=Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers (SCCNFP); REPORT_DATE=20 June 2006; VALUE_TEXT=800; DOSE=y in rats the maximum non lethal dose of the test item was >2000 mg/kg bw.; LOAEL_VALUE=50 mg/kg bw/d; EFFECT=y in rats the maximum non lethal dose of the test item was >2000 mg/kg bw. In an oral subchronic toxicity in rats, the LOAEL is considered being at 50 mg/kg bw/d due to the change in kidney weight in this group. Oral administration of HC Violet n° 1 to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered, the NOAEL of embryotoxicity is 800 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"82576-75-8","citation":"","dose":"y in rats the maximum non lethal dose of the test item was >2000 mg/kg bw.","duration":"subchronic","effect":"y in rats the maximum non lethal dose of the test item was >2000 mg/kg bw. In an oral subchronic toxicity in rats, the LOAEL is considered being at 50 mg/kg bw/d due to the change in kidney weight in this group. Oral administration of HC Violet n° 1 to pregnant rats during organogenesis induced maternal toxicity at 800 mg/kg bw/day. The NOAEL of maternal toxicity is 200 mg/kg bw/day. There was no evidence of embryolethality, embryonic growth retardation or teratogenicity at any of the dose levels administered, the NOAEL of embryotoxicity is 800 mg/kg bw/d.","endpoint":"repeated dose toxicity","ingredient":"HC Violet n° 1 (INCI name)","loael_value":"50 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"800","page":26,"route":"oral","species":"rat","study_id":"sccp_o_063_noael_004"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 0R7XO4T22K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0R7XO4T22K"}
openFDA substances FDA UNII substance identifier 0R7XO4T22K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0R7XO4T22K"}
openFDA substances FDA UNII substance identifier 0R7XO4T22K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0R7XO4T22K"}
openFDA substances FDA UNII substance identifier 0R7XO4T22K UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0R7XO4T22K"}