NOAEL Studies Cosmetic Ingredient

Basic Yellow 57 NOAEL Studies

INCI: BASIC YELLOW 57

CAS: 68391-31-1

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 100 mg/kg bw/day rat oral 90 day Subchronic SCCS; van Otterdijk, F.M. Repeated dose 90-day oral toxicity study with C 010 by daily gavage in the rat followed by a 28-day recovery period. NOTOX B.V., s’Hertogenbosch,Archive code atHenkel KGaA, Düsseldorf, Report No. R 0500469
SCCNFP_vision_codex 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =20 mg/kg - dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"The body weight gain of treated animals was comparable to the control group.","effect":"l chemistry and urine- analyses were performed. Opthalmological examinations were performed at the start and end of the study. At autopsy, organ weights were recorded and the main organs were examined macroscopically and histologically. Results No mortalities occurred. The body weight gain of treated animals was comparable to the control group. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_001"}
SCCNFP_vision_codex NOAEL =50 mg/kg bw/day rat oral 12 weeks irritation {"dose":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw.","effect":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw. Basic Yellow 57 was administered for 12 weeks by oral gavage to Wistar rats at 50 mg/kg bw. The dose level of 50 mg/kg bw/day was considered to be on the borderline of toxicity. In another 13 week study, Basic Yellow 57 was administered by oral gavage to Sprague Dawley rats at 20 mg/kg bw. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Basic Yellow 57 produced no indications of maternal toxicity, embryo-toxicity or teratogenicity under the test conditions employed at the dose of 50 mg/kg bw/day. Basic Yellow 57 was considered “not irritant” to rabbit skin. It provoked no effects on the cornea or iris in any of the test animals. However, there was a discoloration of the conjunctivae. A mild reaction could have been masked by the discoloration caused by the dye. This test was conducted at a concentration below the intended in-use maximum of 2%. P","page":19,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_002"}
SCCNFP_vision_codex NOAEL =20 mg/kg - dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"The body weight gain of treated animals was comparable to the control group.","effect":"l chemistry and urine- analyses were performed. Opthalmological examinations were performed at the start and end of the study. At autopsy, organ weights were recorded and the main organs were examined macroscopically and histologically. Results No mortalities occurred. The body weight gain of treated animals was comparable to the control group. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_001"}
SCCNFP_vision_codex NOAEL =50 mg/kg bw/day rat oral 12 weeks irritation {"dose":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw.","effect":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw. Basic Yellow 57 was administered for 12 weeks by oral gavage to Wistar rats at 50 mg/kg bw. The dose level of 50 mg/kg bw/day was considered to be on the borderline of toxicity. In another 13 week study, Basic Yellow 57 was administered by oral gavage to Sprague Dawley rats at 20 mg/kg bw. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Basic Yellow 57 produced no indications of maternal toxicity, embryo-toxicity or teratogenicity under the test conditions employed at the dose of 50 mg/kg bw/day. Basic Yellow 57 was considered “not irritant” to rabbit skin. It provoked no effects on the cornea or iris in any of the test animals. However, there was a discoloration of the conjunctivae. A mild reaction could have been masked by the discoloration caused by the dye. This test was conducted at a concentration below the intended in-use maximum of 2%. P","page":19,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_002"}
SCCNFP_vision_codex NOAEL =20 mg/kg - dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"The body weight gain of treated animals was comparable to the control group.","effect":"l chemistry and urine- analyses were performed. Opthalmological examinations were performed at the start and end of the study. At autopsy, organ weights were recorded and the main organs were examined macroscopically and histologically. Results No mortalities occurred. The body weight gain of treated animals was comparable to the control group. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_001"}
SCCNFP_vision_codex NOAEL =50 mg/kg bw/day rat oral 12 weeks irritation {"dose":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw.","effect":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw. Basic Yellow 57 was administered for 12 weeks by oral gavage to Wistar rats at 50 mg/kg bw. The dose level of 50 mg/kg bw/day was considered to be on the borderline of toxicity. In another 13 week study, Basic Yellow 57 was administered by oral gavage to Sprague Dawley rats at 20 mg/kg bw. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Basic Yellow 57 produced no indications of maternal toxicity, embryo-toxicity or teratogenicity under the test conditions employed at the dose of 50 mg/kg bw/day. Basic Yellow 57 was considered “not irritant” to rabbit skin. It provoked no effects on the cornea or iris in any of the test animals. However, there was a discoloration of the conjunctivae. A mild reaction could have been masked by the discoloration caused by the dye. This test was conducted at a concentration below the intended in-use maximum of 2%. P","page":19,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_002"}
SCCNFP_vision_codex NOAEL =20 mg/kg - dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 9 2","dose":"The body weight gain of treated animals was comparable to the control group.","effect":"l chemistry and urine- analyses were performed. Opthalmological examinations were performed at the start and end of the study. At autopsy, organ weights were recorded and the main organs were examined macroscopically and histologically. Results No mortalities occurred. The body weight gain of treated animals was comparable to the control group. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_001"}
SCCNFP_vision_codex NOAEL =50 mg/kg bw/day rat oral 12 weeks irritation {"dose":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw.","effect":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw. Basic Yellow 57 was administered for 12 weeks by oral gavage to Wistar rats at 50 mg/kg bw. The dose level of 50 mg/kg bw/day was considered to be on the borderline of toxicity. In another 13 week study, Basic Yellow 57 was administered by oral gavage to Sprague Dawley rats at 20 mg/kg bw. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Basic Yellow 57 produced no indications of maternal toxicity, embryo-toxicity or teratogenicity under the test conditions employed at the dose of 50 mg/kg bw/day. Basic Yellow 57 was considered “not irritant” to rabbit skin. It provoked no effects on the cornea or iris in any of the test animals. However, there was a discoloration of the conjunctivae. A mild reaction could have been masked by the discoloration caused by the dye. This test was conducted at a concentration below the intended in-use maximum of 2%. P","page":19,"pdf":"out217_en.pdf","row_type":"noael_study","study_id":"out217_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies irritation 50 mg/kg bw/day rat oral 12 weeks irritation SOURCE_SUBDIR=out217_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC YELLOW 57 COLIPA n° C10; OPINION_NUMBER=SCCNFP/0679/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=50; DOSE=y in rats, the LD50 was between 1000 and 2000 mg/kg bw.; EFFECT=y in rats, the LD50 was between 1000 and 2000 mg/kg bw. Basic Yellow 57 was administered for 12 weeks by oral gavage to Wistar rats at 50 mg/kg bw. The dose level of 50 mg/kg bw/day was considered to be on the borderline of toxicity. In another 13 week study, Basic Yellow 57 was administered by oral gavage to Sprague Dawley rats at 20 mg/kg bw. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Basic Yellow 57 produced no indications of maternal toxicity, embryo-toxicity or teratogenicity under the test conditions employed at the dose of 50 mg/kg bw/day. Basic Yellow 57 was considered “not irritant” to rabbit skin. It provoked no effects on the cornea or iris in any of the test animals. However, there was a discoloration of the conjunctivae. A mild reaction could have been masked by the discoloration caused by the dye. This test was conducted at a concentration below the intended in-use maximum of 2%. P; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-31-1","citation":"","dose":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw.","duration":"12 weeks","effect":"y in rats, the LD50 was between 1000 and 2000 mg/kg bw. Basic Yellow 57 was administered for 12 weeks by oral gavage to Wistar rats at 50 mg/kg bw. The dose level of 50 mg/kg bw/day was considered to be on the borderline of toxicity. In another 13 week study, Basic Yellow 57 was administered by oral gavage to Sprague Dawley rats at 20 mg/kg bw. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Basic Yellow 57 produced no indications of maternal toxicity, embryo-toxicity or teratogenicity under the test conditions employed at the dose of 50 mg/kg bw/day. Basic Yellow 57 was considered “not irritant” to rabbit skin. It provoked no effects on the cornea or iris in any of the test animals. However, there was a discoloration of the conjunctivae. A mild reaction could have been masked by the discoloration caused by the dye. This test was conducted at a concentration below the intended in-use maximum of 2%. P","endpoint":"irritation","ingredient":"presented for Basic Yellow 57 is not correct. All tests","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":19,"route":"oral","species":"rat","study_id":"out217_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 20 mg/kg - dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out217_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC YELLOW 57 COLIPA n° C10; OPINION_NUMBER=SCCNFP/0679/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=20; DOSE=The body weight gain of treated animals was comparable to the control group.; EFFECT=l chemistry and urine- analyses were performed. Opthalmological examinations were performed at the start and end of the study. At autopsy, organ weights were recorded and the main organs were examined macroscopically and histologically. Results No mortalities occurred. The body weight gain of treated animals was comparable to the control group. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data; CITATION=Ref. : 9 2; CITATION_NUMBERS=[9,2]; REFERENCE=Ref. : 9 2; DETAILS_JSON={"cas_number":"68391-31-1","citation":"Ref. : 9 2","dose":"The body weight gain of treated animals was comparable to the control group.","duration":"Sub-chronic","effect":"l chemistry and urine- analyses were performed. Opthalmological examinations were performed at the start and end of the study. At autopsy, organ weights were recorded and the main organs were examined macroscopically and histologically. Results No mortalities occurred. The body weight gain of treated animals was comparable to the control group. There were no indications of treatment-related effects from clinical, macroscopic or microscopic examinations. The dose of 20 mg/kg body weight/day was considered to be the NOAEL. Ref. : 9 2.3.8. Sub-chronic dermal toxicity No data","endpoint":"repeated dose toxicity","ingredient":"presented for Basic Yellow 57 is not correct. All tests","loael_value":"","noael_unit":"mg/kg","noael_value":"20","page":8,"route":"dermal","species":"","study_id":"out217_en_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 4N63359G0X UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H22N5O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4N63359G0X"}
openFDA substances FDA UNII substance identifier 4N63359G0X UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H22N5O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4N63359G0X"}
openFDA substances FDA UNII substance identifier 4N63359G0X UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H22N5O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4N63359G0X"}
openFDA substances FDA UNII substance identifier 4N63359G0X UNII - - - chemical {"approval_status":null,"molecular_formula":"C19H22N5O.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4N63359G0X"}