NOAEL Studies Cosmetic Ingredient

HC Yellow No. 7 NOAEL Studies

INCI: HC YELLOW NO. 7

CAS: 104226-21-3

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 10 mg/kg bw/day rat oral 90 day Subchronic SCCS; C. Fabreguettes. Imexine AA: 13 Week Toxicity Study by oral Route in Rats. CIT Study No. 11390 TCR
SCCNFP_vision_codex 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =80 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day.","effect":"gested that the hepatic hypertrophy was in response to an increased functional demand. Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day. Administration of HC Yellow No. 7 at a dose of 250 mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic to","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_001"}
SCCNFP_vision_codex NOAEL =25 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"mg/kg bw/day was associated with liver and kidney changes.","effect":"mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_002"}
SCCNFP_vision_codex NOAEL =80 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day.","effect":"gested that the hepatic hypertrophy was in response to an increased functional demand. Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day. Administration of HC Yellow No. 7 at a dose of 250 mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic to","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_001"}
SCCNFP_vision_codex NOAEL =25 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"mg/kg bw/day was associated with liver and kidney changes.","effect":"mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_002"}
SCCNFP_vision_codex NOAEL =80 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day.","effect":"gested that the hepatic hypertrophy was in response to an increased functional demand. Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day. Administration of HC Yellow No. 7 at a dose of 250 mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic to","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_001"}
SCCNFP_vision_codex NOAEL =25 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"mg/kg bw/day was associated with liver and kidney changes.","effect":"mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_002"}
SCCNFP_vision_codex NOAEL =80 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day.","effect":"gested that the hepatic hypertrophy was in response to an increased functional demand. Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day. Administration of HC Yellow No. 7 at a dose of 250 mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic to","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_001"}
SCCNFP_vision_codex NOAEL =25 mg/kg bw/day - oral Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"mg/kg bw/day was associated with liver and kidney changes.","effect":"mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","page":7,"pdf":"out216_en.pdf","row_type":"noael_study","study_id":"out216_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies dermal absorption 25 mg/kg bw/day human - - dermal absorption SOURCE_SUBDIR=out216_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW NO. 7 COLIPA n° B80; OPINION_NUMBER=SCCNFP/0675/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=25; DOSE=The incidence of skeletal abnormalities related to delayed ossification was significantly greater at 240 mg/kg bw/day than in controls.; EFFECT=ve foetuses. The incidence of skeletal abnormalities related to delayed ossification was significantly greater at 240 mg/kg bw/day than in controls. A small number of foetal malformations were observed, which were within the normal range, and treated groups did not differ significantly from control. There was slight maternal toxicity at 80 mg/kg bw/day, and moderate maternal toxicity, with subsequent delayed foetal skeletal development, at 240 mg/kg bw/day, but no evidence of embryo-toxicity or teratogenicity. The NOAEL for maternal toxicity was considered to be 25 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human abdominal epidermis Method : Franz diffusion cell (static) Test substance : IMEXINE AA, 0.12% in formulation Batch no : Op 26 Purity : / Dose levels : Circa 40mg formulation in the presence/absence of hair Replicate cells : 8 GLP : Not in compliance The skin penetration of HC Yellow No. 7 was evaluated in a static; CITATION=Ref. : 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref. : 11 2; DETAILS_JSON={"cas_number":"104226-21-3","citation":"Ref. : 11 2","dose":"The incidence of skeletal abnormalities related to delayed ossification was significantly greater at 240 mg/kg bw/day than in controls.","duration":"","effect":"ve foetuses. The incidence of skeletal abnormalities related to delayed ossification was significantly greater at 240 mg/kg bw/day than in controls. A small number of foetal malformations were observed, which were within the normal range, and treated groups did not differ significantly from control. There was slight maternal toxicity at 80 mg/kg bw/day, and moderate maternal toxicity, with subsequent delayed foetal skeletal development, at 240 mg/kg bw/day, but no evidence of embryo-toxicity or teratogenicity. The NOAEL for maternal toxicity was considered to be 25 mg/kg bw/day. Ref. : 11 2.7. Toxicokinetics (including Percutaneous Absorption) 2.7.1. Percutaneous Absorption in vitro Study 1 Guideline : / Tissue : Human abdominal epidermis Method : Franz diffusion cell (static) Test substance : IMEXINE AA, 0.12% in formulation Batch no : Op 26 Purity : / Dose levels : Circa 40mg formulation in the presence/absence of hair Replicate cells : 8 GLP : Not in compliance The skin penetration of HC Yellow No. 7 was evaluated in a static","endpoint":"dermal absorption","ingredient":"1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":11,"route":"","species":"human","study_id":"out216_en_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies irritation 25 mg/kg bw/day rat oral 4-week irritation SOURCE_SUBDIR=out216_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW NO. 7 COLIPA n° B80; OPINION_NUMBER=SCCNFP/0675/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=25; DOSE=A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day.; EFFECT=orted. Chemical purity was not stated in many toxicity study reports. Trace unknowns were detected, whose health hazard properties have not been clarified. No adequate experimental data on stability were provided. HC Yellow No. 7 was “minimally irritant” to the rabbit eye and non-irritant to rabbit skin. It has shown evidence of sensitisation at a concentration of 2.5%. A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day. The NOAEL was 25 mg/kg bw/day. This is consistent with results of a teratogenicity study in which slight maternal toxicity was seen at 80 mg/kg bw/day, and moderate maternal toxicity, with subsequent delayed foetal skeletal development, at 240 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 25 mg/kg bw/day. Percutaneous penetration : almost all of the hair dye applied was recovered at the skin surface in the washing liquids. The absorbed amounts of HC Yellow No. 7 (epidermis + dermis + receptor fluid) rep; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"104226-21-3","citation":"","dose":"A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day.","duration":"4-week","effect":"orted. Chemical purity was not stated in many toxicity study reports. Trace unknowns were detected, whose health hazard properties have not been clarified. No adequate experimental data on stability were provided. HC Yellow No. 7 was “minimally irritant” to the rabbit eye and non-irritant to rabbit skin. It has shown evidence of sensitisation at a concentration of 2.5%. A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day. The NOAEL was 25 mg/kg bw/day. This is consistent with results of a teratogenicity study in which slight maternal toxicity was seen at 80 mg/kg bw/day, and moderate maternal toxicity, with subsequent delayed foetal skeletal development, at 240 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 25 mg/kg bw/day. Percutaneous penetration : almost all of the hair dye applied was recovered at the skin surface in the washing liquids. The absorbed amounts of HC Yellow No. 7 (epidermis + dermis + receptor fluid) rep","endpoint":"irritation","ingredient":"1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":16,"route":"oral","species":"rat","study_id":"out216_en_noael_004"}
UnifiedCodex:SCCNFP:beta.noael_studies irritation 25 mg/kg bw/day rat oral 4-week irritation SOURCE_SUBDIR=out216_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW NO. 7 COLIPA n° B80; OPINION_NUMBER=SCCNFP/0675/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=25; DOSE=A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day.; EFFECT=the rabbit eye and non-irritant to rabbit skin. It has shown evidence of sensitisation at a concentration of 2.5%. A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day. The NOAEL was 25 mg/kg bw/day. This is consistent with results of a teratogenicity study in which slight maternal toxicity was seen at 80 mg/kg bw/day, and moderate maternal toxicity, with subsequent delayed foetal skeletal development, at 240 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 25 mg/kg bw/day. Percutaneous penetration : almost all of the hair dye applied was recovered at the skin surface in the washing liquids. The absorbed amounts of HC Yellow No. 7 (epidermis + dermis + receptor fluid) represents 0.05 ± 0.003 % of the applied dose (0.011 ± 0.008 µg/cm2) at the end of 24 hours of diffusion after a contact with the skin of 30 minutes. The substance induced gene mutations in bacteria and mammalian cells. It was negative in an in vivo UDS study.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"104226-21-3","citation":"","dose":"A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day.","duration":"4-week","effect":"the rabbit eye and non-irritant to rabbit skin. It has shown evidence of sensitisation at a concentration of 2.5%. A 4-week rat oral study gave evidence of liver and kidney damage at 250 mg/kg bw/day and staining of the fundus of the eye at 80 mg/kg bw/day. The NOAEL was 25 mg/kg bw/day. This is consistent with results of a teratogenicity study in which slight maternal toxicity was seen at 80 mg/kg bw/day, and moderate maternal toxicity, with subsequent delayed foetal skeletal development, at 240 mg/kg bw/day. The NOAEL for maternal toxicity was considered to be 25 mg/kg bw/day. Percutaneous penetration : almost all of the hair dye applied was recovered at the skin surface in the washing liquids. The absorbed amounts of HC Yellow No. 7 (epidermis + dermis + receptor fluid) represents 0.05 ± 0.003 % of the applied dose (0.011 ± 0.008 µg/cm2) at the end of 24 hours of diffusion after a contact with the skin of 30 minutes. The substance induced gene mutations in bacteria and mammalian cells. It was negative in an in vivo UDS study.","endpoint":"irritation","ingredient":"1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":16,"route":"oral","species":"rat","study_id":"out216_en_noael_005"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 80 mg/kg bw/day - oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out216_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW NO. 7 COLIPA n° B80; OPINION_NUMBER=SCCNFP/0675/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=80; DOSE=Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day.; EFFECT=gested that the hepatic hypertrophy was in response to an increased functional demand. Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day. Administration of HC Yellow No. 7 at a dose of 250 mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic to; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"104226-21-3","citation":"Ref. : 5 2","dose":"Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day.","duration":"Sub-chronic","effect":"gested that the hepatic hypertrophy was in response to an increased functional demand. Multifocal myopathy was seen in the skeletal muscle in some animals of both sexes at 250 mg/kg bw/day. Administration of HC Yellow No. 7 at a dose of 250 mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic to","endpoint":"repeated dose toxicity","ingredient":"1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"80","page":7,"route":"oral","species":"","study_id":"out216_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 25 mg/kg bw/day - oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out216_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW NO. 7 COLIPA n° B80; OPINION_NUMBER=SCCNFP/0675/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=25; DOSE=mg/kg bw/day was associated with liver and kidney changes.; EFFECT=mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"104226-21-3","citation":"Ref. : 5 2","dose":"mg/kg bw/day was associated with liver and kidney changes.","duration":"Sub-chronic","effect":"mg/kg bw/day was associated with liver and kidney changes. At 80 mg/kg bw/day the only findings attributable to the test article were orange fur and tail staining, coloration of the urine, and a bilateral coloration of the fundus of the eye. The study authors concluded that the NOAEL was 80 mg/kg bw/day. The basophilia suggests regeneration of damaged cells and is common if tubular nephrosis is reported. The toxicological importance of the observations in the eye at 80 mg/kg bw/day are not clear and therefore the NOAEL should be 25 mg/kg bw/day. Ref. : 5 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity No data 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data","endpoint":"repeated dose toxicity","ingredient":"1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl)aminobenzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"25","page":7,"route":"oral","species":"","study_id":"out216_en_noael_002"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 6L0860JBFE UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H22N4O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6L0860JBFE"}
openFDA substances FDA UNII substance identifier 6L0860JBFE UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H22N4O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6L0860JBFE"}
openFDA substances FDA UNII substance identifier 6L0860JBFE UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H22N4O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6L0860JBFE"}
openFDA substances FDA UNII substance identifier 6L0860JBFE UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H22N4O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"6L0860JBFE"}