NOAEL Studies Cosmetic Ingredient

HC Violet No. 2 NOAEL Studies

INCI: HC VIOLET NO. 2

CAS: 104226-19-9

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

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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; M.N. Hopkins. Imexine FAG: 13-week oral (gavage) toxicity study in the rat. Toxicol Laboratories, Report N° LRL/80/94, 1995
SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b","dose":"At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.","effect":"SCCS-rejected applicant NOAEL: nt decreases in RBC and PT were found. Because of staining of the urine the evaluation of several parameters was inhibited. At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14","page":14,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_001"}
SCCS_vision_codex NOAEL =2500 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 12 3","dose":"One foetus of the medium dose exhibited microphthalmia.","effect":"anges in maternal body weight gain and feed consumption were observed. The numbers of resorptions and foetal body weight were unaffected by treatment. One foetus of the medium dose exhibited microphthalmia. No treatment related foetal skeletal and soft tissue anomalies were noted. No treatment- related changes in frequency of variations were found. Conclusion Under the experimental conditions HC Violet N°2 showed no maternal and embryotoxicity as well as no teratogenicity at the doses 500 and 2500 mg/kg bw/d. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity is 2500 mg/kg bw/d. Ref.: 12 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 20","page":20,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1081/07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental","page":21,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_004"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b","dose":"At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.","effect":"SCCS-rejected applicant NOAEL: nt decreases in RBC and PT were found. Because of staining of the urine the evaluation of several parameters was inhibited. At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14","page":14,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_001"}
SCCS_vision_codex NOAEL =2500 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 12 3","dose":"One foetus of the medium dose exhibited microphthalmia.","effect":"anges in maternal body weight gain and feed consumption were observed. The numbers of resorptions and foetal body weight were unaffected by treatment. One foetus of the medium dose exhibited microphthalmia. No treatment related foetal skeletal and soft tissue anomalies were noted. No treatment- related changes in frequency of variations were found. Conclusion Under the experimental conditions HC Violet N°2 showed no maternal and embryotoxicity as well as no teratogenicity at the doses 500 and 2500 mg/kg bw/d. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity is 2500 mg/kg bw/d. Ref.: 12 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 20","page":20,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1081/07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental","page":21,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_004"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b","dose":"At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.","effect":"SCCS-rejected applicant NOAEL: nt decreases in RBC and PT were found. Because of staining of the urine the evaluation of several parameters was inhibited. At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14","page":14,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_001"}
SCCS_vision_codex NOAEL =2500 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 12 3","dose":"One foetus of the medium dose exhibited microphthalmia.","effect":"anges in maternal body weight gain and feed consumption were observed. The numbers of resorptions and foetal body weight were unaffected by treatment. One foetus of the medium dose exhibited microphthalmia. No treatment related foetal skeletal and soft tissue anomalies were noted. No treatment- related changes in frequency of variations were found. Conclusion Under the experimental conditions HC Violet N°2 showed no maternal and embryotoxicity as well as no teratogenicity at the doses 500 and 2500 mg/kg bw/d. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity is 2500 mg/kg bw/d. Ref.: 12 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 20","page":20,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1081/07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental","page":21,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_004"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b","dose":"At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.","effect":"SCCS-rejected applicant NOAEL: nt decreases in RBC and PT were found. Because of staining of the urine the evaluation of several parameters was inhibited. At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14","page":14,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_001"}
SCCS_vision_codex NOAEL =2500 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 12 3","dose":"One foetus of the medium dose exhibited microphthalmia.","effect":"anges in maternal body weight gain and feed consumption were observed. The numbers of resorptions and foetal body weight were unaffected by treatment. One foetus of the medium dose exhibited microphthalmia. No treatment related foetal skeletal and soft tissue anomalies were noted. No treatment- related changes in frequency of variations were found. Conclusion Under the experimental conditions HC Violet N°2 showed no maternal and embryotoxicity as well as no teratogenicity at the doses 500 and 2500 mg/kg bw/d. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity is 2500 mg/kg bw/d. Ref.: 12 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 20","page":20,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw rat oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1081/07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental","page":21,"pdf":"sccp_o_112.pdf","row_type":"noael_study","study_id":"sccp_o_112_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw/d - - - - SOURCE_SUBDIR=sccp_o_112; REPORT_TITLE=OPINION ON HC Violet n° 2 COLIPA n° B98; OPINION_NUMBER=SCCP/1081/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=50; DOSE=At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.; EFFECT=SCCS-rejected applicant NOAEL: nt decreases in RBC and PT were found. Because of staining of the urine the evaluation of several parameters was inhibited. At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14; CITATION=Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b; CITATION_NUMBERS=[6,50]; REFERENCE=Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b; DETAILS_JSON={"cas_number":"104226-19-9","citation":"Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b","dose":"At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.","duration":"","effect":"SCCS-rejected applicant NOAEL: nt decreases in RBC and PT were found. Because of staining of the urine the evaluation of several parameters was inhibited. At 800 mg/kg bw/d increases in liver (absolute and relative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14","endpoint":"","ingredient":"HC Violet No. 2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":14,"route":"","species":"","study_id":"sccp_o_112_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw/d - - - - SOURCE_SUBDIR=sccp_o_112; REPORT_TITLE=OPINION ON HC Violet n° 2 COLIPA n° B98; OPINION_NUMBER=SCCP/1081/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=50; DOSE=lative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.; EFFECT=SCCS-rejected applicant NOAEL: lative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14; CITATION=Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b; CITATION_NUMBERS=[6,50]; REFERENCE=Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b; DETAILS_JSON={"cas_number":"104226-19-9","citation":"Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed b","dose":"lative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed.","duration":"","effect":"SCCS-rejected applicant NOAEL: lative) and kidney (relative) weights were found for both sexes, at 200 mg/kg bw/d also liver weight changes in males (absolute and relative) and females (relative) were observed. At this dose only in females the relative kidney weight was affected. But no histopathological changes were seen. Conclusion The study authors concluded that the NOEL is 50 mg/kg bw/d. Ref.: 6 Comment of the SCCP Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. 14","endpoint":"","ingredient":"HC Violet No. 2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":14,"route":"","species":"","study_id":"sccp_o_112_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 2500 mg/kg bw/d human oral - - SOURCE_SUBDIR=sccp_o_112; REPORT_TITLE=OPINION ON HC Violet n° 2 COLIPA n° B98; OPINION_NUMBER=SCCP/1081/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=2500; DOSE=One foetus of the medium dose exhibited microphthalmia.; EFFECT=anges in maternal body weight gain and feed consumption were observed. The numbers of resorptions and foetal body weight were unaffected by treatment. One foetus of the medium dose exhibited microphthalmia. No treatment related foetal skeletal and soft tissue anomalies were noted. No treatment- related changes in frequency of variations were found. Conclusion Under the experimental conditions HC Violet N°2 showed no maternal and embryotoxicity as well as no teratogenicity at the doses 500 and 2500 mg/kg bw/d. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity is 2500 mg/kg bw/d. Ref.: 12 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 20; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"104226-19-9","citation":"Ref.: 12 3","dose":"One foetus of the medium dose exhibited microphthalmia.","duration":"","effect":"anges in maternal body weight gain and feed consumption were observed. The numbers of resorptions and foetal body weight were unaffected by treatment. One foetus of the medium dose exhibited microphthalmia. No treatment related foetal skeletal and soft tissue anomalies were noted. No treatment- related changes in frequency of variations were found. Conclusion Under the experimental conditions HC Violet N°2 showed no maternal and embryotoxicity as well as no teratogenicity at the doses 500 and 2500 mg/kg bw/d. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity is 2500 mg/kg bw/d. Ref.: 12 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 20","endpoint":"","ingredient":"HC Violet No. 2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2500","page":20,"route":"oral","species":"human","study_id":"sccp_o_112_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg bw rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_112; REPORT_TITLE=OPINION ON HC Violet n° 2 COLIPA n° B98; OPINION_NUMBER=SCCP/1081/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=SCCP/1081/07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"104226-19-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"90-day","effect":"SCCP/1081/07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental","endpoint":"dermal absorption","ingredient":"HC Violet No. 2","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 50","page":21,"route":"oral","species":"rat","study_id":"sccp_o_112_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =50 mg/kg bw rat oral 90-day dermal absorption SOURCE_SUBDIR=sccp_o_112; REPORT_TITLE=OPINION ON HC Violet n° 2 COLIPA n° B98; OPINION_NUMBER=SCCP/1081/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT== 50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 200; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"104226-19-9","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"90-day","effect":"07 Opinion on HC Violet n° 2 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (HC Violet n° 2) (Direct / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 1.44 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 1.008 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.017 mg/kg bw No observed effect level NOAEL = 50 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 2941 3.3.14. Discussion Physico-chemical properties HC Violet n° 2 is a secondary (and tertiary) amine and thus is prone to nitrosation. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 200","endpoint":"dermal absorption","ingredient":"HC Violet No. 2","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 50","page":21,"route":"oral","species":"rat","study_id":"sccp_o_112_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 50 mg/kg bw/d mouse dermal - dermal absorption SOURCE_SUBDIR=sccp_o_112; REPORT_TITLE=OPINION ON HC Violet n° 2 COLIPA n° B98; OPINION_NUMBER=SCCP/1081/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=50; DOSE=General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg.; EFFECT=nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg. The acute dermal toxicity was higher than 2000 mg/kg bw. Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity was 2500 mg/kg bw/d. Irritation / sensitisation Undiluted IMEXINE FAG was non-irritant to intact rabbit skin. It produced transient eye irritation. HC Violet n° 2 induced contact sensitisation in mice in the Local Lymph Node Assay. It is a moderate sensitiser. Dermal absorption The dermal absorption (sum of the amounts measured in the epidermis + dermis + receptor fluid) of HC Vi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"104226-19-9","citation":"","dose":"General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg.","duration":"","effect":"nitrosating substances. The nitrosamine content should be < 50 ppb. Data on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg. The acute dermal toxicity was higher than 2000 mg/kg bw. Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity was 2500 mg/kg bw/d. Irritation / sensitisation Undiluted IMEXINE FAG was non-irritant to intact rabbit skin. It produced transient eye irritation. HC Violet n° 2 induced contact sensitisation in mice in the Local Lymph Node Assay. It is a moderate sensitiser. Dermal absorption The dermal absorption (sum of the amounts measured in the epidermis + dermis + receptor fluid) of HC Vi","endpoint":"dermal absorption","ingredient":"HC Violet No. 2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":21,"route":"dermal","species":"mouse","study_id":"sccp_o_112_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 50 mg/kg bw/d mouse dermal - dermal absorption SOURCE_SUBDIR=sccp_o_112; REPORT_TITLE=OPINION ON HC Violet n° 2 COLIPA n° B98; OPINION_NUMBER=SCCP/1081/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=2 October 2007; VALUE_TEXT=50; DOSE=General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg.; EFFECT=ta on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg. The acute dermal toxicity was higher than 2000 mg/kg bw. Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity was 2500 mg/kg bw/d. Irritation / sensitisation Undiluted IMEXINE FAG was non-irritant to intact rabbit skin. It produced transient eye irritation. HC Violet n° 2 induced contact sensitisation in mice in the Local Lymph Node Assay. It is a moderate sensitiser. Dermal absorption The dermal absorption (sum of the amounts measured in the epidermis + dermis + receptor fluid) of HC Violet n° 2 incorporated at 1.93% in a typical semi-permanent hair dye fo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"104226-19-9","citation":"","dose":"General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg.","duration":"","effect":"ta on nitrosamine content is not provided. Only one batch was fully characterized. The stability of the test substance in marketed products was not reported. General toxicity Under the experimental conditions, the LD50 of HC Violet n° 2 was higher than 2000 mg/kg. The acute dermal toxicity was higher than 2000 mg/kg bw. Since the borderline change of one haematological parameter at all doses was not considered toxicologically significant, the NOAEL of 50 mg/kg bw/d proposed by the study authors was accepted. The NOAEL of maternal toxicity, embryo/foetotoxicity and teratogenicity was 2500 mg/kg bw/d. Irritation / sensitisation Undiluted IMEXINE FAG was non-irritant to intact rabbit skin. It produced transient eye irritation. HC Violet n° 2 induced contact sensitisation in mice in the Local Lymph Node Assay. It is a moderate sensitiser. Dermal absorption The dermal absorption (sum of the amounts measured in the epidermis + dermis + receptor fluid) of HC Violet n° 2 incorporated at 1.93% in a typical semi-permanent hair dye fo","endpoint":"dermal absorption","ingredient":"HC Violet No. 2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":21,"route":"dermal","species":"mouse","study_id":"sccp_o_112_noael_007"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 639H4QR04O UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"639H4QR04O"}
openFDA substances FDA UNII substance identifier 639H4QR04O UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"639H4QR04O"}
openFDA substances FDA UNII substance identifier 639H4QR04O UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"639H4QR04O"}
openFDA substances FDA UNII substance identifier 639H4QR04O UNII - - - chemical {"approval_status":null,"molecular_formula":"C13H21N3O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"639H4QR04O"}