NOAEL Studies Cosmetic Ingredient

HC Red No. 3 NOAEL Studies

INCI: HC RED NO. 3

CAS: 2871-01-4

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 15 mg/kg bw/day mouse oral 13 week Subchronic SCCS; Toxicology and Carcinogenesis Studies of HC Red No. 3 in F344/N Rats and B6C3F1Mice (Gavage Studies), National Toxicology Program, Technical Report Series No. 281,January 1986, DHHS
IARC Monographs 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1992 IARC Monographs {"additional_info":"volume_publication_year=1993","evaluation_year":1992,"source_table":"iarc_classifications","volume":"57"}
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >1000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_5033; row=3909; data_type=In Vivo; mixture=Chemical; chemical_name=HC Red 3; preferred_name=HC Red 3; dtxsid=DTXSID2021236; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID2021236; source_file=acute_oral.xlsx
NTP_ICE_cancer 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer IARC group 3 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=2609; Record_ID=cancer_34; Data_Type=WOE; Formulation_Name=HC Red 3; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/75; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP_ICE_cancer Top dose 250 mg/kg bw/day Mouse Gavage - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=2606; Record_ID=cancer_32; Data_Type=In Vivo; Formulation_Name=HC Red 3; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=250; Response_Unit=mg/kg/day; Species=Mouse; Strain=B6C3F1; Sex=Male; Route=Gavage; Reference=TR-281; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr281/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP_ICE_cancer Top dose 500 mg/kg bw/day Rat Gavage - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=2611; Record_ID=cancer_37; Data_Type=In Vivo; Formulation_Name=HC Red 3; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=500; Response_Unit=mg/kg/day; Species=Rat; Strain=F344/N; Sex=Female; Route=Gavage; Reference=TR-281; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr281/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP_ICE_skin_sensitization 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization EC3 2.2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13175; Record_ID=skin_sensitization_invivo_3200; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP_ICE_skin_sensitization EC3 2.2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13175; Record_ID=skin_sensitization_invivo_3200; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP_ICE_skin_sensitization EC3 2.2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13175; Record_ID=skin_sensitization_invivo_3200; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
NTP_ICE_skin_sensitization EC3 2.2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13175; Record_ID=skin_sensitization_invivo_3200; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2021236; Assay=LLNA; Endpoint=EC3; Response=2.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2021236; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2021236
SCCS_vision_codex 96 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"animals was maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"in mean body weight gains were not dose related.","effect":"in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/day o","page":22,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":41,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"nificant differences in the number of live foetuses were observed between treated and control animals.","effect":"nificant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_008"}
SCCS_vision_codex NOAEL =1000 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"oetuses were observed between treated and control animals.","effect":"oetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_009"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad","page":44,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"mitted 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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_013"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"as maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"body weight gains were not dose related.","effect":"body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/d of","page":24,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":43,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide","dose":"ant differences in the number of live foetuses were observed between treated and control animals.","effect":"ant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Ex","page":45,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_008"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made","page":46,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_011"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"4/12 Opinion on HC Red n° 3 ___________________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d M","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"_______________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_013"}
SCCS_vision_codex NOAEL =50 % mouse oral 90-day dermal absorption {"dose":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the t","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_014"}
SCCS_vision_codex NOAEL =0.003 mg/kg bw mouse oral 90-day dermal absorption {"dose":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Der...","effect":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characte","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_015"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0...","effect":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisation and purity of several other test batches is not described. In addition, the test materials were","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_017"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"animals was maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"in mean body weight gains were not dose related.","effect":"in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/day o","page":22,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":41,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"nificant differences in the number of live foetuses were observed between treated and control animals.","effect":"nificant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_008"}
SCCS_vision_codex NOAEL =1000 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"oetuses were observed between treated and control animals.","effect":"oetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_009"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad","page":44,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"mitted 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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_013"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"animals was maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"in mean body weight gains were not dose related.","effect":"in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/day o","page":22,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":41,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"nificant differences in the number of live foetuses were observed between treated and control animals.","effect":"nificant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_008"}
SCCS_vision_codex NOAEL =1000 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"oetuses were observed between treated and control animals.","effect":"oetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_009"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad","page":44,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"mitted 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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_013"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"as maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"body weight gains were not dose related.","effect":"body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/d of","page":24,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":43,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide","dose":"ant differences in the number of live foetuses were observed between treated and control animals.","effect":"ant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Ex","page":45,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_008"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made","page":46,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_011"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"4/12 Opinion on HC Red n° 3 ___________________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d M","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"_______________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_013"}
SCCS_vision_codex NOAEL =50 % mouse oral 90-day dermal absorption {"dose":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the t","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_014"}
SCCS_vision_codex NOAEL =0.003 mg/kg bw mouse oral 90-day dermal absorption {"dose":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Der...","effect":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characte","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_015"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0...","effect":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisation and purity of several other test batches is not described. In addition, the test materials were","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_017"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"as maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"body weight gains were not dose related.","effect":"body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/d of","page":24,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":43,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide","dose":"ant differences in the number of live foetuses were observed between treated and control animals.","effect":"ant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Ex","page":45,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_008"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made","page":46,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_011"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"4/12 Opinion on HC Red n° 3 ___________________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d M","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"_______________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_013"}
SCCS_vision_codex NOAEL =50 % mouse oral 90-day dermal absorption {"dose":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the t","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_014"}
SCCS_vision_codex NOAEL =0.003 mg/kg bw mouse oral 90-day dermal absorption {"dose":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Der...","effect":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characte","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_015"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0...","effect":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisation and purity of several other test batches is not described. In addition, the test materials were","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_017"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"animals was maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"in mean body weight gains were not dose related.","effect":"in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","page":20,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","page":21,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/day o","page":22,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":41,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"nificant differences in the number of live foetuses were observed between treated and control animals.","effect":"nificant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_008"}
SCCS_vision_codex NOAEL =1000 mg/kg/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"oetuses were observed between treated and control animals.","effect":"oetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","page":43,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_009"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad","page":44,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_011"}
SCCS_vision_codex NOAEL =0.01 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","effect":"mitted 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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","page":45,"pdf":"sccs_o_043.pdf","row_type":"noael_study","study_id":"sccs_o_043_noael_013"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","effect":"as maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat oral 14-day repeated dose toxicity {"citation":"Ref.: 17 3","dose":"body weight gains were not dose related.","effect":"body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","page":22,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_002"}
SCCS_vision_codex NOAEL =250 mg/kg bw/d rat oral 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_003"}
SCCS_vision_codex NOAEL =125 mg/kg bw/d rat - 5 days NOAEL study {"citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","page":23,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_004"}
SCCS_vision_codex NOAEL =0.02 % mouse oral Chronic NOAEL study {"citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/d of","page":24,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_006"}
SCCS_vision_codex NOAEL =7800 ppm - - 13 days reproductive toxicity {"citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","page":43,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_007"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d rabbit oral developmental developmental toxicity {"citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide","dose":"ant differences in the number of live foetuses were observed between treated and control animals.","effect":"ant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Ex","page":45,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_008"}
SCCS_vision_codex NOAEL =97.5 - - - - NOAEL study {"citation":"Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made","page":46,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_011"}
SCCS_vision_codex NOAEL =0.015 mg/kg bw mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"4/12 Opinion on HC Red n° 3 ___________________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d M","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_012"}
SCCS_vision_codex NOAEL =90 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","effect":"_______________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_013"}
SCCS_vision_codex NOAEL =50 % mouse oral 90-day dermal absorption {"dose":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","effect":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the t","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_014"}
SCCS_vision_codex NOAEL =0.003 mg/kg bw mouse oral 90-day dermal absorption {"dose":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Der...","effect":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characte","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_015"}
SCCS_vision_codex NOAEL =45 mg/kg bw/d mouse oral 90-day dermal absorption {"dose":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0...","effect":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisation and purity of several other test batches is not described. In addition, the test materials were","page":48,"pdf":"sccs_o_107.pdf","row_type":"noael_study","study_id":"sccs_o_107_noael_017"}
ToxValDB_ECHA_IUCLID 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =200 mg/kg bw/day Rat oral - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac1ae4b0a7c65d1bd5a2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/9/3?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823058_15824717:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_11b3a43756889e85f14d9dd54e56dbc6
ToxValDB_ECHA_IUCLID NOAEL =1000 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac1ae4b0a7c65d1bd59a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/9/3?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823058_15824717:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_222d0559cef807d44d496b09b41ed244
ToxValDB_ECHA_IUCLID NOAEL >500 mg/kg bw/day Mouse oral short-term; 14 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb04e4b0a7c65d2248ba; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/6/2?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=clinical signs|gross pathology|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|gross pathology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15849375:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_648207453de897c2994217d326904565
ToxValDB_ECHA_IUCLID NOAEL >250 mg/kg bw/day Mouse oral subchronic; 13 weeks subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae06e4b0a7c65d1c71e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22771/7/6/2?documentUUID=2ac25915-d18c-4c07-82b1-eed21940e2da; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|gross pathology|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|gross pathology|nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15849377:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d27ba623329de4eb9d85f97dfb7aa9b3
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 37 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 250 mg/kg bw/d rat oral 5 days - SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=250; DOSE=The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.; EFFECT=SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","duration":"5 days","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","endpoint":"","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":21,"route":"oral","species":"rat","study_id":"sccs_o_043_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 125 mg/kg bw/d rat - 5 days - SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=125; DOSE=ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.; EFFECT=SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","duration":"5 days","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","endpoint":"","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":21,"route":"","species":"rat","study_id":"sccs_o_043_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 250 mg/kg bw/d rat - 5 days - SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=250; DOSE=Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week:; EFFECT=SCCS-rejected applicant NOAEL: urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week:","duration":"5 days","effect":"SCCS-rejected applicant NOAEL: urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Guideline: Not specified Species/strain: Eppley Swiss mice","endpoint":"","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":21,"route":"","species":"rat","study_id":"sccs_o_043_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 0.02 % mouse oral Chronic - SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=0.02; DOSE=Chronic inflammation of the skin was observed in the control and treated mice.; EFFECT=toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/day o; CITATION=Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[27]; REFERENCE=Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","duration":"Chronic","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/day o","endpoint":"","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"%","noael_value":"0.02","page":22,"route":"oral","species":"mouse","study_id":"sccs_o_043_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 97.5 - - - - - SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=unclear:rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad; DOSE=Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.; EFFECT=rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad; CITATION=Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[28]; REFERENCE=Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","duration":"","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad","endpoint":"","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"","noael_value":"unclear:rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 µg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be mad","page":44,"route":"","species":"","study_id":"sccs_o_043_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 250 mg/kg bw/d rat oral 5 days - SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=250; DOSE=The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.; EFFECT=SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","duration":"5 days","effect":"SCCS-rejected applicant NOAEL: ated to gavage technique. The final mean body weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","endpoint":"","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccs_o_107_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 125 mg/kg bw/d rat - 5 days - SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=125; DOSE=ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.; EFFECT=SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls.","duration":"5 days","effect":"SCCS-rejected applicant NOAEL: ody weights of males that received doses of 250 mg/kg bw/d were 7% lower than those of controls. Final body weights of dosed female were comparable to those of controls. The urine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","endpoint":"","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"125","page":23,"route":"","species":"rat","study_id":"sccs_o_107_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 250 mg/kg bw/d rat - 5 days - SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=250; DOSE=Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week:; EFFECT=SCCS-rejected applicant NOAEL: ine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week:","duration":"5 days","effect":"SCCS-rejected applicant NOAEL: ine of all dosed animals was red throughout the studies. No compound-related gross or microscopic pathologic effects were recorded. Conclusion Pigmentation was not considered by the applicant as adverse effects and based on the body weight decrease observed at 1000 mg/kg bw/d and 500 mg/kg bw/d, the NOAEL is 250 mg/kg bw/d in rats while the NOEL is 125 mg/kg bw/d (adjusted for 5 days treatment per week: 180 and 90 mg/kg bw/d, respectively). In mice, based on the body weight decrease observed at 250 mg/kg bw/d the NOAEL is 125 mg/kg bw/d (adjusted to 90 mg/kg bw/d). Ref.: 17 3.3.5.3. Chronic (> 12 months) toxicity Taken from SCCS/1293/10 Guideline: Not specified Species/strain: Eppley Swiss mice Group size: 60 male and 60 female mice per dose","endpoint":"","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":23,"route":"","species":"rat","study_id":"sccs_o_107_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 0.02 % mouse oral Chronic - SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.02; DOSE=Chronic inflammation of the skin was observed in the control and treated mice.; EFFECT=toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/d of; CITATION=Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[27]; REFERENCE=Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"Chronic inflammation of the skin was observed in the control and treated mice.","duration":"Chronic","effect":"toxicological effects. Microscopic examinations of the skin revealed occasional hyperplasia, necrosis, ulceration and other lesions not significantly increased by dye treatment. Chronic inflammation of the skin was observed in the control and treated mice. Ref.: 27 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article are not known. Different hair dye formulations were tested in this study. The results are sparsely reported. No NOAEL can be derived from this study. Guideline: / Species/strain: Beagles Group size: 36 (6 Animals per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral in diet Exposure period: 24 months GLP: not in compliance Study period: Before 1975 36 beagle dogs were orally exposed daily during 2 years with an hair dye formulation containing 0.02% HC Red n° 3 at the doses of 0, 19.5 and 97.5 mg/kg bw/d of","endpoint":"","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"%","noael_value":"0.02","page":24,"route":"oral","species":"mouse","study_id":"sccs_o_107_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 97.5 - - - - - SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=unclear:rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made; DOSE=Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.; EFFECT=rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made; CITATION=Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[28]; REFERENCE=Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP","dose":"Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing.","duration":"","effect":"rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made","endpoint":"","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"","noael_value":"unclear:rmal foetuses and no soft tissues defects were seen. The principle findings of the skeletal examination were variations in the degree of ossification and in the number of ribs in this species. The distribution of these changes showed no relationship to treatment. Animals receiving the high dose excreted blue-brown coloured urine within an hour after dosing. Urine colour was normal the next day prior to dosing which indicates a rapid elimination. Conclusion Based on the results of this study, a maternal and foetal NOAEL of 97.5 mg test material/ kg bw/d corresponding to 19.5 μg/kg bw/d of HC Red n° 3 was proposed by the applicant. Ref.: 28 Comment The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can therefore be made","page":46,"route":"","species":"","study_id":"sccs_o_107_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.01 mg/kg bw mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT== 0.01; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...; EFFECT=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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","duration":"90-day","effect":"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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.01","page":45,"route":"oral","species":"mouse","study_id":"sccs_o_043_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =90 mg/kg bw/d mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT== 90; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...; EFFECT=mitted 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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","duration":"90-day","effect":"mitted 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 HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 90","page":45,"route":"oral","species":"mouse","study_id":"sccs_o_043_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =90 mg/kg bw/d mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT== 90; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...; EFFECT=l investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x...","duration":"90-day","effect":"l investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + 2SD) = 1.58 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg bw No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) Margin of Safety NOAEL / SED = 9000","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 90","page":45,"route":"oral","species":"mouse","study_id":"sccs_o_043_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.015 mg/kg bw mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 0.015; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...; EFFECT=4/12 Opinion on HC Red n° 3 ___________________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d M; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","duration":"90-day","effect":"4/12 Opinion on HC Red n° 3 ___________________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d M","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.015","page":48,"route":"oral","species":"mouse","study_id":"sccs_o_107_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =90 mg/kg bw/d mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 90; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...; EFFECT=_______________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A...","duration":"90-day","effect":"_______________________________________________________________________________________ 48 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 90","page":48,"route":"oral","species":"mouse","study_id":"sccs_o_107_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 50 % mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=50; DOSE=fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...; EFFECT=fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x...","duration":"90-day","effect":"fety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY HC Red n° 3 (non-oxidative conditions) Absorption through the skin A (mean + SD) = 1.58 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.92 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the t","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"%","noael_value":"50","page":48,"route":"oral","species":"mouse","study_id":"sccs_o_107_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.003 mg/kg bw mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 0.003; DOSE=uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Der...; EFFECT=uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characte; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Der...","duration":"90-day","effect":"uman = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characte","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.003","page":48,"route":"oral","species":"mouse","study_id":"sccs_o_107_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =90 mg/kg bw/d mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 90; DOSE=ose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS...; EFFECT=ose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisati; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"ose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS...","duration":"90-day","effect":"ose (SED) SAS x A x 0.001/60 = 0.015 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisati","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 90","page":48,"route":"oral","species":"mouse","study_id":"sccs_o_107_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =45 mg/kg bw/d mouse oral 90-day dermal absorption SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 45; DOSE=g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0...; EFFECT=g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisation and purity of several other test batches is not described. In addition, the test materials were; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0...","duration":"90-day","effect":"g bw/d (90-day, oral, mice) = 45 mg/kg bw/d 50% bioavailability* Margin of Safety NOAEL / SED = 3000 (oxidative conditions) Absorption through the skin A (mean + SD) = 0.333 μg/cm² Skin Area surface SAS = 580 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.19mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.003 mg/kg bw bw/d No observed adverse effect level NOAEL = 90 mg/kg bw/d (90-day, oral, mice) 50% bioavailability* = 45 mg/kg bw/d Margin of Safety NOAEL / SED = 14000 * standard procedure according to the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 3.3.14. Discussion Physico-chemical properties HC Red n° 3 is used in semi-permanent hair dye formulations at a maximum concentration of 3.0%. Chemical characterisation as well as purity and impurities of three batches of HC Red n° 3 is provided, while the characterisation and purity of several other test batches is not described. In addition, the test materials were","endpoint":"dermal absorption","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 45","page":48,"route":"oral","species":"mouse","study_id":"sccs_o_107_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=200; DOSE=nificant differences in the number of live foetuses were observed between treated and control animals.; EFFECT=nificant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage; CITATION=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:; CITATION_NUMBERS=[26,1000]; REFERENCE=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"nificant differences in the number of live foetuses were observed between treated and control animals.","duration":"developmental","effect":"nificant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg/d","noael_value":"200","page":43,"route":"oral","species":"rabbit","study_id":"sccs_o_043_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=1000; DOSE=oetuses were observed between treated and control animals.; EFFECT=oetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage; CITATION=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:; CITATION_NUMBERS=[26,1000]; REFERENCE=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"oetuses were observed between treated and control animals.","duration":"developmental","effect":"oetuses were observed between treated and control animals. Reversible delays in ossification, ie reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1000","page":43,"route":"oral","species":"rabbit","study_id":"sccs_o_043_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=1000; DOSE=rved in the 1000 mg/kg/d dosage group and were considered to be related to the test substance.; EFFECT=rved in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage; CITATION=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:; CITATION_NUMBERS=[26,1000]; REFERENCE=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline:","dose":"rved in the 1000 mg/kg/d dosage group and were considered to be related to the test substance.","duration":"developmental","effect":"rved in the 1000 mg/kg/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg/d and the developmental NOAEL was 1000 mg/kg/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1000","page":43,"route":"oral","species":"rabbit","study_id":"sccs_o_043_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d rat oral 5 days developmental toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=1000; DOSE=NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study.; EFFECT=thyroid gland and in the kidney of rats was also observed but not considered as an adverse effect. NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study. Some long term toxicity studies by dermal routes with hair dye formulations were provided but as these studies did not follow guidelines and were not performed under GLP conditions, they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n°3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg/d and a developmental NOAEL of 1000 mg/kg/d were d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study.","duration":"5 days","effect":"thyroid gland and in the kidney of rats was also observed but not considered as an adverse effect. NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study. Some long term toxicity studies by dermal routes with hair dye formulations were provided but as these studies did not follow guidelines and were not performed under GLP conditions, they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n°3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg/d and a developmental NOAEL of 1000 mg/kg/d were d","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":46,"route":"oral","species":"rat","study_id":"sccs_o_043_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=200; DOSE=In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.; EFFECT=GLP conditions, they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n°3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg/d and a developmental NOAEL of 1000 mg/kg/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin. A 3% preparation in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.","duration":"developmental","effect":"GLP conditions, they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n°3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg/d and a developmental NOAEL of 1000 mg/kg/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin. A 3% preparation in","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg/d","noael_value":"200","page":46,"route":"oral","species":"rat","study_id":"sccs_o_043_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=1000; DOSE=In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.; EFFECT=ppropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n°3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg/d and a developmental NOAEL of 1000 mg/kg/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin. A 3% preparation in ‘Schultz Vehicle’ caused no irritation. N; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.","duration":"developmental","effect":"ppropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n°3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg/d and a developmental NOAEL of 1000 mg/kg/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin. A 3% preparation in ‘Schultz Vehicle’ caused no irritation. N","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1000","page":46,"route":"oral","species":"rat","study_id":"sccs_o_043_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=200; DOSE=ant differences in the number of live foetuses were observed between treated and control animals.; EFFECT=ant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Ex; CITATION=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide; CITATION_NUMBERS=[26,1000]; REFERENCE=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide","dose":"ant differences in the number of live foetuses were observed between treated and control animals.","duration":"developmental","effect":"ant differences in the number of live foetuses were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Ex","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":45,"route":"oral","species":"rabbit","study_id":"sccs_o_107_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1000; DOSE=were observed between treated and control animals.; EFFECT=were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Exposure period: once daily on Day 6 through Day; CITATION=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide; CITATION_NUMBERS=[26,1000]; REFERENCE=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide","dose":"were observed between treated and control animals.","duration":"developmental","effect":"were observed between treated and control animals. Reversible delays in ossification, i.e. reduction in the number of ossified hindlimbs metatarsals and phalanges were observed in the 1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Exposure period: once daily on Day 6 through Day","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":45,"route":"oral","species":"rabbit","study_id":"sccs_o_107_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d rabbit oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1000; DOSE=1000 mg/kg bw/d dosage group and were considered to be related to the test substance.; EFFECT=1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Exposure period: once daily on Day 6 through Day 18 GLP: not in compliance Study period: before 1975; CITATION=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide; CITATION_NUMBERS=[26,1000]; REFERENCE=Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guide","dose":"1000 mg/kg bw/d dosage group and were considered to be related to the test substance.","duration":"developmental","effect":"1000 mg/kg bw/d dosage group and were considered to be related to the test substance. However these delays were minor in nature, not associated with decreased foetal body weights and are considered to be non-adverse variations. Conclusion Based on the results of this study, the maternal NOAEL was 200 mg/kg bw/d and the developmental NOAEL was 1000 mg/kg bw/d. Ref.: 26 Comments Since the delayed ossification observed in the foetus at 1000 mg/kg bw/d are considered to be due to maternal toxicity, the developmental NOAEL is 1000 mg/kg bw/d Guideline: / Species/strain: New Zealand white rabbits Group size: 48 (12 female per sex and dose) Test substance: Hair dye formulation containing 0.02% HC Red n° 3. Batch: / Purity: / Dose: 0, 19.5 and 97.5 mg/kg bw/day of hair dye formulation Route: Oral, gavage Exposure period: once daily on Day 6 through Day 18 GLP: not in compliance Study period: before 1975","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":45,"route":"oral","species":"rabbit","study_id":"sccs_o_107_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d rat oral 5 days developmental toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1000; DOSE=NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study.; EFFECT=pithelial cells in the thyroid gland and in the kidney of rats was also observed but not considered as an adverse effect. NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study. The provided long term toxicity studies by dermal routes with hair dye formulations did not follow OECD guidelines and were not performed under GLP conditions; they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n° 3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg bw/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg bw/d and a developmental NOAEL of 1000 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study.","duration":"5 days","effect":"pithelial cells in the thyroid gland and in the kidney of rats was also observed but not considered as an adverse effect. NOAELs of 250 mg/kg bw/d in rats and 125 mg/kg bw/d in mice (adjusted to 180 and 90 mg/kg bw/d, respectively for 5 days/week treatment) may be derived from this 90 days oral toxicity study. The provided long term toxicity studies by dermal routes with hair dye formulations did not follow OECD guidelines and were not performed under GLP conditions; they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n° 3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg bw/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg bw/d and a developmental NOAEL of 1000 mg/kg bw","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":49,"route":"oral","species":"rat","study_id":"sccs_o_107_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 200 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=200; DOSE=In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.; EFFECT=conditions; they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n° 3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg bw/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg bw/d and a developmental NOAEL of 1000 mg/kg bw/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the skin irritation experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.","duration":"developmental","effect":"conditions; they are not considered appropriate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n° 3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg bw/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg bw/d and a developmental NOAEL of 1000 mg/kg bw/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the skin irritation experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin.","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":49,"route":"oral","species":"rat","study_id":"sccs_o_107_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1000; DOSE=In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.; EFFECT=iate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n° 3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg bw/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg bw/d and a developmental NOAEL of 1000 mg/kg bw/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the skin irritation experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin. A 3% preparation in ‘Schultz Vehicle’ cause; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2871-01-4","citation":"","dose":"In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d.","duration":"developmental","effect":"iate to derive a NOAEL for HC Red n° 3. In oral developmental toxicity studies performed in rats, a decrease in body weight and food consumption of female rats was observed at 1000 mg/kg bw/d. On foetuses, the only toxic effect related to HC Red n° 3 observed was a reduction in the numbers of ossified hindlimbs metatarsals and phalanges in the 1000 mg/kg bw/d dosage group, which was considered to be due to maternal toxicity. Based on the results of this study, a maternal NOAEL of 200 mg/kg bw/d and a developmental NOAEL of 1000 mg/kg bw/d were derived. A two-generation toxicity study with oral administration of a hair dye formulation was provided but not considered suitable for safety evaluation. Skin/eye irritation and sensitisation None of the skin irritation experiments followed a guideline and the specifications of the test substance were not described. Curiously, the 3% aqueous solution caused some irritation in one experiment while the slurry caused no irritation to rabbit skin. A 3% preparation in ‘Schultz Vehicle’ cause","endpoint":"developmental toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":49,"route":"oral","species":"rat","study_id":"sccs_o_107_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg bw/d rat oral 14-day repeated dose toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=1000; DOSE=Differences in mean body weight gains were not dose related.; EFFECT=animals was maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","duration":"14-day","effect":"animals was maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","endpoint":"repeated dose toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":20,"route":"oral","species":"rat","study_id":"sccs_o_043_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 500 mg/kg bw/d rat oral 14-day repeated dose toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=500; DOSE=in mean body weight gains were not dose related.; EFFECT=in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"in mean body weight gains were not dose related.","duration":"14-day","effect":"in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg/d, 2/5 males that received 500 mg/kg/d and 2/5 males that received 250 mg/kg/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d","endpoint":"repeated dose toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":20,"route":"oral","species":"rat","study_id":"sccs_o_043_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 1000 mg/kg bw/d rat oral 14-day repeated dose toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1000; DOSE=Differences in mean body weight gains were not dose related.; EFFECT=as maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"Differences in mean body weight gains were not dose related.","duration":"14-day","effect":"as maroon to orange throughout the studies. Differences in mean body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","endpoint":"repeated dose toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":22,"route":"oral","species":"rat","study_id":"sccs_o_107_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 500 mg/kg bw/d rat oral 14-day repeated dose toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=500; DOSE=body weight gains were not dose related.; EFFECT=body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral; CITATION=Ref.: 17 3; CITATION_NUMBERS=[17,3]; REFERENCE=Ref.: 17 3; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 17 3","dose":"body weight gains were not dose related.","duration":"14-day","effect":"body weight gains were not dose related. Dark thyroid glands were observed in 5/5 male rats that received 1000 mg/kg bw/d, 2/5 males that received 500 mg/kg bw/d and 2/5 males that received 250 mg/kg bw/d. Mice All animals survived to the end of the studies. The urine of all dosed animals was maroon to orange throughout the studies. Mean body weight gains were comparable between dosed or control groups. Conclusion In the 14-day gavage rat study, the NOAEL was 1000 mg/kg bw/d. In the 14-day gavage mice study, the NOAEL was 500 mg/kg bw/d. Ref.: 17 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCS/1293/10 Guideline: / Species/strain: F344/N rat, B6C3F1 mice Group size: 10 male and 10 female rats, and 10 male and 10 female mice per dose Test substance: HC Red n° 3 Batch: Lot 5890377 Purity: >97% Dose levels: Rats: 0, 62, 125, 250, 500 and 1000 mg/kg bw/d Mice: 0, 15, 31, 62, 125 and 250 mg/kg bw/d Vehicle: corn oil Route: oral","endpoint":"repeated dose toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":22,"route":"oral","species":"rat","study_id":"sccs_o_107_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 7800 ppm - - 13 days reproductive toxicity SOURCE_SUBDIR=sccs_o_043; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1293/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2010; VALUE_TEXT=7800; DOSE=No dose related significant differences in male fertility were observed.; EFFECT=No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon; CITATION=Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[28]; REFERENCE=Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","duration":"13 days","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","endpoint":"reproductive toxicity","ingredient":"2-[(4-Amino-2","loael_value":"","noael_unit":"ppm","noael_value":"7800","page":41,"route":"","species":"","study_id":"sccs_o_043_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 7800 ppm - - 13 days reproductive toxicity SOURCE_SUBDIR=sccs_o_107; REPORT_TITLE=OPINION ON HC Red n° 3 COLIPA n° B50; OPINION_NUMBER=SCCS/1474/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=7800; DOSE=No dose related significant differences in male fertility were observed.; EFFECT=No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon; CITATION=Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP; CITATION_NUMBERS=[28]; REFERENCE=Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP; DETAILS_JSON={"cas_number":"2871-01-4","citation":"Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP","dose":"No dose related significant differences in male fertility were observed.","duration":"13 days","effect":"No dose related significant differences in male fertility were observed. No effects on body weight gains and food consumption were observed. Foetal parameters No significant differences were observed in any of the parameters examined including live pups per litter, pup body weights and pup survival. No abnormal pups were observed upon dissection of embryos after 13 days of gestation or upon gross examination at weaning after 21 days. Conclusion Based on the results of this study, a maternal, paternal and foetal NOAEL of 7800 ppm of the test material/ kg bw/d was proposed by the applicant. Ref.: 28 Comments The experiment did not conform to a guideline and was not performed according to GLP. The purity and specifications of test article is not known. Different hair dyes were tested in this study. The concentration of HC Red n° 3 tested was too low compared to commercial formulations. The results are sparsely reported. No conclusions concerning long term toxic effects can then be made from this study. The highest dose correspon","endpoint":"reproductive toxicity","ingredient":"2-[(4-Amino-2-nitrophenyl) amino]ethanol has","loael_value":"","noael_unit":"ppm","noael_value":"7800","page":43,"route":"","species":"","study_id":"sccs_o_107_noael_007"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 51CPX7M1SQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"51CPX7M1SQ"}
openFDA substances FDA UNII substance identifier 51CPX7M1SQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"51CPX7M1SQ"}
openFDA substances FDA UNII substance identifier 51CPX7M1SQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"51CPX7M1SQ"}
openFDA substances FDA UNII substance identifier 51CPX7M1SQ UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"51CPX7M1SQ"}