NOAEL Studies Cosmetic Ingredient

HC Yellow No. 13 NOAEL Studies

INCI: HC YELLOW NO. 13

CAS: 10442-83-8

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

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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 10 mg/kg bw/day rat oral 91 day Subchronic SCCS; 90-Day toxicity study with "Fluorgelb II" in rats. Hruby, 1991
SCCNFP_vision_codex 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =2.5 % rat dermal developmental developmental toxicity {"citation":"Ref. : 13 2","dose":"HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies. Ref. : 13 2.7. Toxicokinetics (incl. Percutaneous Absorption) Guideline : / Species : Sprague Dawley Him: OFA rat Group size : 3 male and 3 female Route : topical Material : 14C-Fluorgelb II at 2.5% in formulations with and without hydrogen peroxide, and in water/DMSO (1:2) Batch no : AZ 212 (purity 98%) Dose level : Approximately 1g for each formulation or solution GLP : in compliance 14C-labelled Fluorgelb II, included in two different hair dye formulations (at 2.5%) with and without","page":11,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_004"}
SCCNFP_vision_codex NOAEL =2.5 % rat dermal developmental developmental toxicity {"citation":"Ref. : 13 2","dose":"HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies. Ref. : 13 2.7. Toxicokinetics (incl. Percutaneous Absorption) Guideline : / Species : Sprague Dawley Him: OFA rat Group size : 3 male and 3 female Route : topical Material : 14C-Fluorgelb II at 2.5% in formulations with and without hydrogen peroxide, and in water/DMSO (1:2) Batch no : AZ 212 (purity 98%) Dose level : Approximately 1g for each formulation or solution GLP : in compliance 14C-labelled Fluorgelb II, included in two different hair dye formulations (at 2.5%) with and without","page":11,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_004"}
SCCNFP_vision_codex NOAEL =2.5 % rat dermal developmental developmental toxicity {"citation":"Ref. : 13 2","dose":"HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies. Ref. : 13 2.7. Toxicokinetics (incl. Percutaneous Absorption) Guideline : / Species : Sprague Dawley Him: OFA rat Group size : 3 male and 3 female Route : topical Material : 14C-Fluorgelb II at 2.5% in formulations with and without hydrogen peroxide, and in water/DMSO (1:2) Batch no : AZ 212 (purity 98%) Dose level : Approximately 1g for each formulation or solution GLP : in compliance 14C-labelled Fluorgelb II, included in two different hair dye formulations (at 2.5%) with and without","page":11,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_004"}
SCCNFP_vision_codex NOAEL =2.5 % rat dermal developmental developmental toxicity {"citation":"Ref. : 13 2","dose":"HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies. Ref. : 13 2.7. Toxicokinetics (incl. Percutaneous Absorption) Guideline : / Species : Sprague Dawley Him: OFA rat Group size : 3 male and 3 female Route : topical Material : 14C-Fluorgelb II at 2.5% in formulations with and without hydrogen peroxide, and in water/DMSO (1:2) Batch no : AZ 212 (purity 98%) Dose level : Approximately 1g for each formulation or solution GLP : in compliance 14C-labelled Fluorgelb II, included in two different hair dye formulations (at 2.5%) with and without","page":11,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_004"}
SCCNFP_vision_codex NOAEL =30 mg/kg rabbit dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"No pancreatic changes were found in any intermediate-dose animals.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 7 related. No pancreatic changes were found in any intermediate-dose animals. No other treatment- related effects were reported. The dose of 30 mg/kg/bw/day was considered as NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on diluted material Guideline : OECD n° 404 Species : New Zealand white rabbit Group size : 6 (sex not specified) Material : 5% Fluorgelb II suspended in propylene glycol (pH 6.5) Batch no : AR 902 Purity : 99.7 % Dose : 0.5 ml on 6 cm2 GLP : in compliance 0.5 ml of a 5% solution of the test material in propylene glycol was","page":7,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_001"}
SCCNFP_vision_codex NOAEL =30 mg/kg rabbit dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"No pancreatic changes were found in any intermediate-dose animals.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 7 related. No pancreatic changes were found in any intermediate-dose animals. No other treatment- related effects were reported. The dose of 30 mg/kg/bw/day was considered as NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on diluted material Guideline : OECD n° 404 Species : New Zealand white rabbit Group size : 6 (sex not specified) Material : 5% Fluorgelb II suspended in propylene glycol (pH 6.5) Batch no : AR 902 Purity : 99.7 % Dose : 0.5 ml on 6 cm2 GLP : in compliance 0.5 ml of a 5% solution of the test material in propylene glycol was","page":7,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_001"}
SCCNFP_vision_codex NOAEL =30 mg/kg rabbit dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"No pancreatic changes were found in any intermediate-dose animals.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 7 related. No pancreatic changes were found in any intermediate-dose animals. No other treatment- related effects were reported. The dose of 30 mg/kg/bw/day was considered as NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on diluted material Guideline : OECD n° 404 Species : New Zealand white rabbit Group size : 6 (sex not specified) Material : 5% Fluorgelb II suspended in propylene glycol (pH 6.5) Batch no : AR 902 Purity : 99.7 % Dose : 0.5 ml on 6 cm2 GLP : in compliance 0.5 ml of a 5% solution of the test material in propylene glycol was","page":7,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_001"}
SCCNFP_vision_codex NOAEL =30 mg/kg rabbit dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"No pancreatic changes were found in any intermediate-dose animals.","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 7 related. No pancreatic changes were found in any intermediate-dose animals. No other treatment- related effects were reported. The dose of 30 mg/kg/bw/day was considered as NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on diluted material Guideline : OECD n° 404 Species : New Zealand white rabbit Group size : 6 (sex not specified) Material : 5% Fluorgelb II suspended in propylene glycol (pH 6.5) Batch no : AR 902 Purity : 99.7 % Dose : 0.5 ml on 6 cm2 GLP : in compliance 0.5 ml of a 5% solution of the test material in propylene glycol was","page":7,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_001"}
SCCNFP_vision_codex NOAEL =90 mg/kg bw - - - reproductive toxicity {"dose":"Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material.","effect":"and no pups were delivered prematurely. Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material. No other treatment- related effects were observed in the dams. Foetuses : in groups treated with 30 and 90 mg/kg bw there was a slight but not statistically significant decrease of viable foetuses per female and an increase in the number of post- implantation losses. No skeletal or organ deformities were reported in any of the groups. The study authors concluded that 90 mg/kg/bw was a NOAEL for maternal toxicity, embryotoxicity and teratogenicity. Reproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did","page":10,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_002"}
SCCNFP_vision_codex NOAEL =90 mg/kg rat oral 90-day developmental toxicity {"dose":"In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL.","effect":"t given. Purity of the test material in several studies is not reported. The dye is a secondary alkanolamine, and thus, it is prone to nitrosation. No data is provided on the nitrosamine content of the dye and in hair dye formulations The data provided on stability are insufficient. HC Yellow n° 13 was found to be of low acute oral and dermal toxicity in rats. No signs of eye or skin irritation were observed. The sensitisation test results were negative. In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL. In a rat teratogenicity study, no structural abnormalities were observed in the foetuses, however, there were slight indications of developmental retardations following administration of 30 and 90 mg/kg/bw/day during the critical days of organogenesis. 10 mg/kg bw was the level without developmental anomalies. Skin penetration (rat in vivo study, using 14C-labelled a.i.) indicated a maximum penetration of 2.5 µg/cm2 for oxidative hair dyes (max. in-use concentration 2.5%) , and of 9.69 µg/cm2 for colour setting l","page":17,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_005"}
SCCNFP_vision_codex NOAEL =90 mg/kg bw - - - reproductive toxicity {"dose":"Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material.","effect":"and no pups were delivered prematurely. Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material. No other treatment- related effects were observed in the dams. Foetuses : in groups treated with 30 and 90 mg/kg bw there was a slight but not statistically significant decrease of viable foetuses per female and an increase in the number of post- implantation losses. No skeletal or organ deformities were reported in any of the groups. The study authors concluded that 90 mg/kg/bw was a NOAEL for maternal toxicity, embryotoxicity and teratogenicity. Reproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did","page":10,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_002"}
SCCNFP_vision_codex NOAEL =90 mg/kg rat oral 90-day developmental toxicity {"dose":"In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL.","effect":"t given. Purity of the test material in several studies is not reported. The dye is a secondary alkanolamine, and thus, it is prone to nitrosation. No data is provided on the nitrosamine content of the dye and in hair dye formulations The data provided on stability are insufficient. HC Yellow n° 13 was found to be of low acute oral and dermal toxicity in rats. No signs of eye or skin irritation were observed. The sensitisation test results were negative. In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL. In a rat teratogenicity study, no structural abnormalities were observed in the foetuses, however, there were slight indications of developmental retardations following administration of 30 and 90 mg/kg/bw/day during the critical days of organogenesis. 10 mg/kg bw was the level without developmental anomalies. Skin penetration (rat in vivo study, using 14C-labelled a.i.) indicated a maximum penetration of 2.5 µg/cm2 for oxidative hair dyes (max. in-use concentration 2.5%) , and of 9.69 µg/cm2 for colour setting l","page":17,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_005"}
SCCNFP_vision_codex NOAEL =90 mg/kg bw - - - reproductive toxicity {"dose":"Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material.","effect":"and no pups were delivered prematurely. Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material. No other treatment- related effects were observed in the dams. Foetuses : in groups treated with 30 and 90 mg/kg bw there was a slight but not statistically significant decrease of viable foetuses per female and an increase in the number of post- implantation losses. No skeletal or organ deformities were reported in any of the groups. The study authors concluded that 90 mg/kg/bw was a NOAEL for maternal toxicity, embryotoxicity and teratogenicity. Reproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did","page":10,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_002"}
SCCNFP_vision_codex NOAEL =90 mg/kg rat oral 90-day developmental toxicity {"dose":"In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL.","effect":"t given. Purity of the test material in several studies is not reported. The dye is a secondary alkanolamine, and thus, it is prone to nitrosation. No data is provided on the nitrosamine content of the dye and in hair dye formulations The data provided on stability are insufficient. HC Yellow n° 13 was found to be of low acute oral and dermal toxicity in rats. No signs of eye or skin irritation were observed. The sensitisation test results were negative. In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL. In a rat teratogenicity study, no structural abnormalities were observed in the foetuses, however, there were slight indications of developmental retardations following administration of 30 and 90 mg/kg/bw/day during the critical days of organogenesis. 10 mg/kg bw was the level without developmental anomalies. Skin penetration (rat in vivo study, using 14C-labelled a.i.) indicated a maximum penetration of 2.5 µg/cm2 for oxidative hair dyes (max. in-use concentration 2.5%) , and of 9.69 µg/cm2 for colour setting l","page":17,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_005"}
SCCNFP_vision_codex NOAEL =90 mg/kg bw - - - reproductive toxicity {"dose":"Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material.","effect":"and no pups were delivered prematurely. Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material. No other treatment- related effects were observed in the dams. Foetuses : in groups treated with 30 and 90 mg/kg bw there was a slight but not statistically significant decrease of viable foetuses per female and an increase in the number of post- implantation losses. No skeletal or organ deformities were reported in any of the groups. The study authors concluded that 90 mg/kg/bw was a NOAEL for maternal toxicity, embryotoxicity and teratogenicity. Reproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did","page":10,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_002"}
SCCNFP_vision_codex NOAEL =90 mg/kg rat oral 90-day developmental toxicity {"dose":"In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL.","effect":"t given. Purity of the test material in several studies is not reported. The dye is a secondary alkanolamine, and thus, it is prone to nitrosation. No data is provided on the nitrosamine content of the dye and in hair dye formulations The data provided on stability are insufficient. HC Yellow n° 13 was found to be of low acute oral and dermal toxicity in rats. No signs of eye or skin irritation were observed. The sensitisation test results were negative. In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL. In a rat teratogenicity study, no structural abnormalities were observed in the foetuses, however, there were slight indications of developmental retardations following administration of 30 and 90 mg/kg/bw/day during the critical days of organogenesis. 10 mg/kg bw was the level without developmental anomalies. Skin penetration (rat in vivo study, using 14C-labelled a.i.) indicated a maximum penetration of 2.5 µg/cm2 for oxidative hair dyes (max. in-use concentration 2.5%) , and of 9.69 µg/cm2 for colour setting l","page":17,"pdf":"out208_en.pdf","row_type":"noael_study","study_id":"out208_en_noael_005"}
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies developmental toxicity 2.5 % rat dermal developmental developmental toxicity SOURCE_SUBDIR=out208_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW N° 13 COLIPA n° B102; OPINION_NUMBER=SCCNFP/0689/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=2.5; DOSE=HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies.; EFFECT=SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies. Ref. : 13 2.7. Toxicokinetics (incl. Percutaneous Absorption) Guideline : / Species : Sprague Dawley Him: OFA rat Group size : 3 male and 3 female Route : topical Material : 14C-Fluorgelb II at 2.5% in formulations with and without hydrogen peroxide, and in water/DMSO (1:2) Batch no : AZ 212 (purity 98%) Dose level : Approximately 1g for each formulation or solution GLP : in compliance 14C-labelled Fluorgelb II, included in two different hair dye formulations (at 2.5%) with and without; CITATION=Ref. : 13 2; CITATION_NUMBERS=[13,2]; REFERENCE=Ref. : 13 2; DETAILS_JSON={"cas_number":"10442-83-8","citation":"Ref. : 13 2","dose":"HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies.","duration":"developmental","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 11 In a conservative approach, the SCCNFP considers 10 mg/kg bw as the NOAEL for developmental anomalies. Ref. : 13 2.7. Toxicokinetics (incl. Percutaneous Absorption) Guideline : / Species : Sprague Dawley Him: OFA rat Group size : 3 male and 3 female Route : topical Material : 14C-Fluorgelb II at 2.5% in formulations with and without hydrogen peroxide, and in water/DMSO (1:2) Batch no : AZ 212 (purity 98%) Dose level : Approximately 1g for each formulation or solution GLP : in compliance 14C-labelled Fluorgelb II, included in two different hair dye formulations (at 2.5%) with and without","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"2.5","page":11,"route":"dermal","species":"rat","study_id":"out208_en_noael_004"}
UnifiedCodex:SCCNFP:beta.noael_studies developmental toxicity 90 mg/kg rat oral 90-day developmental toxicity SOURCE_SUBDIR=out208_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW N° 13 COLIPA n° B102; OPINION_NUMBER=SCCNFP/0689/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=90; DOSE=In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL.; EFFECT=t given. Purity of the test material in several studies is not reported. The dye is a secondary alkanolamine, and thus, it is prone to nitrosation. No data is provided on the nitrosamine content of the dye and in hair dye formulations The data provided on stability are insufficient. HC Yellow n° 13 was found to be of low acute oral and dermal toxicity in rats. No signs of eye or skin irritation were observed. The sensitisation test results were negative. In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL. In a rat teratogenicity study, no structural abnormalities were observed in the foetuses, however, there were slight indications of developmental retardations following administration of 30 and 90 mg/kg/bw/day during the critical days of organogenesis. 10 mg/kg bw was the level without developmental anomalies. Skin penetration (rat in vivo study, using 14C-labelled a.i.) indicated a maximum penetration of 2.5 µg/cm2 for oxidative hair dyes (max. in-use concentration 2.5%) , and of 9.69 µg/cm2 for colour setting l; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"10442-83-8","citation":"","dose":"In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL.","duration":"90-day","effect":"t given. Purity of the test material in several studies is not reported. The dye is a secondary alkanolamine, and thus, it is prone to nitrosation. No data is provided on the nitrosamine content of the dye and in hair dye formulations The data provided on stability are insufficient. HC Yellow n° 13 was found to be of low acute oral and dermal toxicity in rats. No signs of eye or skin irritation were observed. The sensitisation test results were negative. In a 90-day oral toxicity study in rats, 30 mg/kg bw was the NOAEL. In a rat teratogenicity study, no structural abnormalities were observed in the foetuses, however, there were slight indications of developmental retardations following administration of 30 and 90 mg/kg/bw/day during the critical days of organogenesis. 10 mg/kg bw was the level without developmental anomalies. Skin penetration (rat in vivo study, using 14C-labelled a.i.) indicated a maximum penetration of 2.5 µg/cm2 for oxidative hair dyes (max. in-use concentration 2.5%) , and of 9.69 µg/cm2 for colour setting l","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"90","page":17,"route":"oral","species":"rat","study_id":"out208_en_noael_005"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 30 mg/kg rabbit dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out208_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW N° 13 COLIPA n° B102; OPINION_NUMBER=SCCNFP/0689/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=30; DOSE=No pancreatic changes were found in any intermediate-dose animals.; EFFECT=SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 7 related. No pancreatic changes were found in any intermediate-dose animals. No other treatment- related effects were reported. The dose of 30 mg/kg/bw/day was considered as NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on diluted material Guideline : OECD n° 404 Species : New Zealand white rabbit Group size : 6 (sex not specified) Material : 5% Fluorgelb II suspended in propylene glycol (pH 6.5) Batch no : AR 902 Purity : 99.7 % Dose : 0.5 ml on 6 cm2 GLP : in compliance 0.5 ml of a 5% solution of the test material in propylene glycol was; CITATION=Ref. : 9 2; CITATION_NUMBERS=[9,2]; REFERENCE=Ref. : 9 2; DETAILS_JSON={"cas_number":"10442-83-8","citation":"Ref. : 9 2","dose":"No pancreatic changes were found in any intermediate-dose animals.","duration":"Sub-chronic","effect":"SCCNFP/0689/03, final Evaluation and opinion on : HC Yellow n° 13 ____________________________________________________________________________________________ 7 related. No pancreatic changes were found in any intermediate-dose animals. No other treatment- related effects were reported. The dose of 30 mg/kg/bw/day was considered as NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Test on diluted material Guideline : OECD n° 404 Species : New Zealand white rabbit Group size : 6 (sex not specified) Material : 5% Fluorgelb II suspended in propylene glycol (pH 6.5) Batch no : AR 902 Purity : 99.7 % Dose : 0.5 ml on 6 cm2 GLP : in compliance 0.5 ml of a 5% solution of the test material in propylene glycol was","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"30","page":7,"route":"dermal","species":"rabbit","study_id":"out208_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies reproductive toxicity 90 mg/kg bw - - - reproductive toxicity SOURCE_SUBDIR=out208_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW N° 13 COLIPA n° B102; OPINION_NUMBER=SCCNFP/0689/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=90; DOSE=Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material.; EFFECT=and no pups were delivered prematurely. Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material. No other treatment- related effects were observed in the dams. Foetuses : in groups treated with 30 and 90 mg/kg bw there was a slight but not statistically significant decrease of viable foetuses per female and an increase in the number of post- implantation losses. No skeletal or organ deformities were reported in any of the groups. The study authors concluded that 90 mg/kg/bw was a NOAEL for maternal toxicity, embryotoxicity and teratogenicity. Reproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"10442-83-8","citation":"","dose":"Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material.","duration":"","effect":"and no pups were delivered prematurely. Urine of animals treated with 30 and 90 mg/kg bw were stained yellow by the test material. No other treatment- related effects were observed in the dams. Foetuses : in groups treated with 30 and 90 mg/kg bw there was a slight but not statistically significant decrease of viable foetuses per female and an increase in the number of post- implantation losses. No skeletal or organ deformities were reported in any of the groups. The study authors concluded that 90 mg/kg/bw was a NOAEL for maternal toxicity, embryotoxicity and teratogenicity. Reproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"90","page":10,"route":"","species":"","study_id":"out208_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies reproductive toxicity 90 mg/kg bw - - - reproductive toxicity SOURCE_SUBDIR=out208_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC YELLOW N° 13 COLIPA n° B102; OPINION_NUMBER=SCCNFP/0689/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=90; DOSE=Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance.; EFFECT=eproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did not show any treatment related effects. 90 mg/kg bw was the NOAEL for maternal toxicity and teratogenicity.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"10442-83-8","citation":"","dose":"Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance.","duration":"","effect":"eproductive performance : there were no significant effects on reproductive performance. Embryolethality was slightly increased at 30 and 90 mg/kg bw but the changes did not reach the level of statistical significance. Foetuses : external foetal observation revealed no gross malformations. Skeletal observations revealed delayed ossification of metacarpals and sternum at 30 and 90 mg/kg bw. No skeletal malformations were observed. Visceral observations did not show any treatment related effects. 90 mg/kg bw was the NOAEL for maternal toxicity and teratogenicity.","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw","noael_value":"90","page":10,"route":"","species":"","study_id":"out208_en_noael_003"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 0448DT2KKS UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H9F3N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0448DT2KKS"}
openFDA substances FDA UNII substance identifier 0448DT2KKS UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H9F3N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0448DT2KKS"}
openFDA substances FDA UNII substance identifier 0448DT2KKS UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H9F3N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0448DT2KKS"}
openFDA substances FDA UNII substance identifier 0448DT2KKS UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H9F3N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0448DT2KKS"}