NOAEL Studies
Cosmetic Ingredient
Basic Yellow 87 NOAEL Studies
INCI: BASIC YELLOW 87
CAS: 68259-00-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 50 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; RCC Project 681311. Subchronic 13-week oral toxicity (feeding) study in the rat |
| COSMOS_DB | NOAEL | 10 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; RCC Project 681311. Subchronic 13-week oral toxicity (feeding) study in the rat |
SCCNFP_vision_codex 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 5 2","dose":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day.","effect":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day. Ref.: 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 2 male, 1 female Test substance : MIP 2982, moistened with water Batch no : 028400A8AA Purity : 87.7 % Dose : 0.5 g GLP : In compliance 0.5 g of moistened test substance was applied to 6.25 cm2 of intact skin of 3 r","page":8,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 5 2","dose":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day.","effect":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day. Ref.: 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 2 male, 1 female Test substance : MIP 2982, moistened with water Batch no : 028400A8AA Purity : 87.7 % Dose : 0.5 g GLP : In compliance 0.5 g of moistened test substance was applied to 6.25 cm2 of intact skin of 3 r","page":8,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 5 2","dose":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day.","effect":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day. Ref.: 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 2 male, 1 female Test substance : MIP 2982, moistened with water Batch no : 028400A8AA Purity : 87.7 % Dose : 0.5 g GLP : In compliance 0.5 g of moistened test substance was applied to 6.25 cm2 of intact skin of 3 r","page":8,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 5 2","dose":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day.","effect":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day. Ref.: 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 2 male, 1 female Test substance : MIP 2982, moistened with water Batch no : 028400A8AA Purity : 87.7 % Dose : 0.5 g GLP : In compliance 0.5 g of moistened test substance was applied to 6.25 cm2 of intact skin of 3 r","page":8,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =39 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"he substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated with vehicle. A complete block de","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =39 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"he substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated with vehicle. A complete block de","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =39 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"he substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated with vehicle. A complete block de","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =39 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"he substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated with vehicle. A complete block de","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw | human | - | - | dermal absorption | {"citation":"Ref.: 11 2","dose":"s and/or urine in the 60 and 180 mg/kg bw groups.","effect":"s and/or urine in the 60 and 180 mg/kg bw groups. At these dose levels reduced food consumption and weight gain were observed. No substance-related changes of reproduction data were noted (number of implantations, resorptions and foetuses, foetal weight, external abnormalities) with the exception of 1 foetus with cleft palate (20 mg/kg bw) and 1 oedematous foetus and a slight increase in foetal weight (180 mg/kg bw). Some observed skeletal abnormalities were not considered to be related to the test substance. The NOAEL of maternal and foetal toxicity is 60 mg/kg bw. Ref.: 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : / Tissue : Human female epidermis, heat-separated Method : Franz diffusion cells (static) 12 cells dosed with test article and 2 with a placebo preparation Test substance : A formulation containing 0.2% MIP 2982 Batch number : CGF-FO16737/16 Dose levels : 90.2-109 mg/cm² (mean 103 ± 1.8 mg/cm²) preparation equals 197 ± 3.3 µ/cm² of MIP2982 GLP : In","page":10,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw | human | - | - | dermal absorption | {"citation":"Ref.: 11 2","dose":"s and/or urine in the 60 and 180 mg/kg bw groups.","effect":"s and/or urine in the 60 and 180 mg/kg bw groups. At these dose levels reduced food consumption and weight gain were observed. No substance-related changes of reproduction data were noted (number of implantations, resorptions and foetuses, foetal weight, external abnormalities) with the exception of 1 foetus with cleft palate (20 mg/kg bw) and 1 oedematous foetus and a slight increase in foetal weight (180 mg/kg bw). Some observed skeletal abnormalities were not considered to be related to the test substance. The NOAEL of maternal and foetal toxicity is 60 mg/kg bw. Ref.: 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : / Tissue : Human female epidermis, heat-separated Method : Franz diffusion cells (static) 12 cells dosed with test article and 2 with a placebo preparation Test substance : A formulation containing 0.2% MIP 2982 Batch number : CGF-FO16737/16 Dose levels : 90.2-109 mg/cm² (mean 103 ± 1.8 mg/cm²) preparation equals 197 ± 3.3 µ/cm² of MIP2982 GLP : In","page":10,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw | human | - | - | dermal absorption | {"citation":"Ref.: 11 2","dose":"s and/or urine in the 60 and 180 mg/kg bw groups.","effect":"s and/or urine in the 60 and 180 mg/kg bw groups. At these dose levels reduced food consumption and weight gain were observed. No substance-related changes of reproduction data were noted (number of implantations, resorptions and foetuses, foetal weight, external abnormalities) with the exception of 1 foetus with cleft palate (20 mg/kg bw) and 1 oedematous foetus and a slight increase in foetal weight (180 mg/kg bw). Some observed skeletal abnormalities were not considered to be related to the test substance. The NOAEL of maternal and foetal toxicity is 60 mg/kg bw. Ref.: 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : / Tissue : Human female epidermis, heat-separated Method : Franz diffusion cells (static) 12 cells dosed with test article and 2 with a placebo preparation Test substance : A formulation containing 0.2% MIP 2982 Batch number : CGF-FO16737/16 Dose levels : 90.2-109 mg/cm² (mean 103 ± 1.8 mg/cm²) preparation equals 197 ± 3.3 µ/cm² of MIP2982 GLP : In","page":10,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg bw | human | - | - | dermal absorption | {"citation":"Ref.: 11 2","dose":"s and/or urine in the 60 and 180 mg/kg bw groups.","effect":"s and/or urine in the 60 and 180 mg/kg bw groups. At these dose levels reduced food consumption and weight gain were observed. No substance-related changes of reproduction data were noted (number of implantations, resorptions and foetuses, foetal weight, external abnormalities) with the exception of 1 foetus with cleft palate (20 mg/kg bw) and 1 oedematous foetus and a slight increase in foetal weight (180 mg/kg bw). Some observed skeletal abnormalities were not considered to be related to the test substance. The NOAEL of maternal and foetal toxicity is 60 mg/kg bw. Ref.: 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : / Tissue : Human female epidermis, heat-separated Method : Franz diffusion cells (static) 12 cells dosed with test article and 2 with a placebo preparation Test substance : A formulation containing 0.2% MIP 2982 Batch number : CGF-FO16737/16 Dose levels : 90.2-109 mg/cm² (mean 103 ± 1.8 mg/cm²) preparation equals 197 ± 3.3 µ/cm² of MIP2982 GLP : In","page":10,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =174 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"rved in all animals receiving the substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated wit","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =174 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"rved in all animals receiving the substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated wit","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =174 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"rved in all animals receiving the substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated wit","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =174 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | {"citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","effect":"rved in all animals receiving the substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated wit","page":6,"pdf":"out238_en.pdf","row_type":"noael_study","study_id":"out238_en_noael_001"} |
UnifiedCodex:SCCNFP:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 60 | mg/kg bw | human | - | - | dermal absorption | SOURCE_SUBDIR=out238_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING Basic Yellow 87; OPINION_NUMBER=SCCNFP/0730/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=60; DOSE=s and/or urine in the 60 and 180 mg/kg bw groups.; EFFECT=s and/or urine in the 60 and 180 mg/kg bw groups. At these dose levels reduced food consumption and weight gain were observed. No substance-related changes of reproduction data were noted (number of implantations, resorptions and foetuses, foetal weight, external abnormalities) with the exception of 1 foetus with cleft palate (20 mg/kg bw) and 1 oedematous foetus and a slight increase in foetal weight (180 mg/kg bw). Some observed skeletal abnormalities were not considered to be related to the test substance. The NOAEL of maternal and foetal toxicity is 60 mg/kg bw. Ref.: 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : / Tissue : Human female epidermis, heat-separated Method : Franz diffusion cells (static) 12 cells dosed with test article and 2 with a placebo preparation Test substance : A formulation containing 0.2% MIP 2982 Batch number : CGF-FO16737/16 Dose levels : 90.2-109 mg/cm² (mean 103 ± 1.8 mg/cm²) preparation equals 197 ± 3.3 µ/cm² of MIP2982 GLP : In; CITATION=Ref.: 11 2; CITATION_NUMBERS=[11,2]; REFERENCE=Ref.: 11 2; DETAILS_JSON={"cas_number":"68259-00-7","citation":"Ref.: 11 2","dose":"s and/or urine in the 60 and 180 mg/kg bw groups.","duration":"","effect":"s and/or urine in the 60 and 180 mg/kg bw groups. At these dose levels reduced food consumption and weight gain were observed. No substance-related changes of reproduction data were noted (number of implantations, resorptions and foetuses, foetal weight, external abnormalities) with the exception of 1 foetus with cleft palate (20 mg/kg bw) and 1 oedematous foetus and a slight increase in foetal weight (180 mg/kg bw). Some observed skeletal abnormalities were not considered to be related to the test substance. The NOAEL of maternal and foetal toxicity is 60 mg/kg bw. Ref.: 11 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption in vitro Guideline : / Tissue : Human female epidermis, heat-separated Method : Franz diffusion cells (static) 12 cells dosed with test article and 2 with a placebo preparation Test substance : A formulation containing 0.2% MIP 2982 Batch number : CGF-FO16737/16 Dose levels : 90.2-109 mg/cm² (mean 103 ± 1.8 mg/cm²) preparation equals 197 ± 3.3 µ/cm² of MIP2982 GLP : In","endpoint":"dermal absorption","ingredient":"1-methyl-4-((methylphenylhydrazono)methyl)-pyridinium, methylsulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"60","page":10,"route":"","species":"human","study_id":"out238_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw/day | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out238_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING Basic Yellow 87; OPINION_NUMBER=SCCNFP/0730/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=10; DOSE=SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day.; EFFECT=SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day. Ref.: 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 2 male, 1 female Test substance : MIP 2982, moistened with water Batch no : 028400A8AA Purity : 87.7 % Dose : 0.5 g GLP : In compliance 0.5 g of moistened test substance was applied to 6.25 cm2 of intact skin of 3 r; CITATION=Ref.: 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref.: 5 2; DETAILS_JSON={"cas_number":"68259-00-7","citation":"Ref.: 5 2","dose":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day.","duration":"Sub-chronic","effect":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 8 The NOAEL is 10 mg/kg bw/day. Ref.: 5 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) Guideline : OECD 404 (1981) Species/strain : New Zealand albino rabbit Group size : 2 male, 1 female Test substance : MIP 2982, moistened with water Batch no : 028400A8AA Purity : 87.7 % Dose : 0.5 g GLP : In compliance 0.5 g of moistened test substance was applied to 6.25 cm2 of intact skin of 3 r","endpoint":"repeated dose toxicity","ingredient":"1-methyl-4-((methylphenylhydrazono)methyl)-pyridinium, methylsulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":8,"route":"dermal","species":"rabbit","study_id":"out238_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw/day | rabbit | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=out238_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING Basic Yellow 87; OPINION_NUMBER=SCCNFP/0730/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=10; DOSE=A repeated dose oral and dermal toxicity study were performed.; EFFECT=SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 18 Results No reactions were observed on both the irradiated and non-irradiated flanks of test and control animals. Ref.: 10 2.11. Safety evaluation Not applicable 2.12. Conclusions No experimental data is provided on stability of the test material. A repeated dose oral and dermal toxicity study were performed. The NOAEL in a subchronic toxicity study was set at 10 mg/kg bw/day. The NOAEL for maternal and foetal toxicity was set at 60 mg/kg bw. Basic Yellow 87 was not irritating to rabbit skin. It was moderately irritating to rabbit eye under the test conditions. In a guinea pig maximization test Basic Yellow 87 was not a sensitizer under the test conditions. The total percutaneous absorption amounted to 0.16 +/- 0.031 µg/cm². The percutaneous absorption of Basic Yellow 87 has not been tested in the presence of an oxidising agen; CITATION=Ref.: 10 2; CITATION_NUMBERS=[10,2]; REFERENCE=Ref.: 10 2; DETAILS_JSON={"cas_number":"68259-00-7","citation":"Ref.: 10 2","dose":"A repeated dose oral and dermal toxicity study were performed.","duration":"subchronic","effect":"SCCNFP/0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 18 Results No reactions were observed on both the irradiated and non-irradiated flanks of test and control animals. Ref.: 10 2.11. Safety evaluation Not applicable 2.12. Conclusions No experimental data is provided on stability of the test material. A repeated dose oral and dermal toxicity study were performed. The NOAEL in a subchronic toxicity study was set at 10 mg/kg bw/day. The NOAEL for maternal and foetal toxicity was set at 60 mg/kg bw. Basic Yellow 87 was not irritating to rabbit skin. It was moderately irritating to rabbit eye under the test conditions. In a guinea pig maximization test Basic Yellow 87 was not a sensitizer under the test conditions. The total percutaneous absorption amounted to 0.16 +/- 0.031 µg/cm². The percutaneous absorption of Basic Yellow 87 has not been tested in the presence of an oxidising agen","endpoint":"repeated dose toxicity","ingredient":"1-methyl-4-((methylphenylhydrazono)methyl)-pyridinium, methylsulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":18,"route":"oral","species":"rabbit","study_id":"out238_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 39 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | SOURCE_SUBDIR=out238_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING Basic Yellow 87; OPINION_NUMBER=SCCNFP/0730/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=39; DOSE=In high dose males the food intake and the mean body weight and body weight gain was slightly lower.; EFFECT=he substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated with vehicle. A complete block de; CITATION=Ref.: 4 2; CITATION_NUMBERS=[4,2]; REFERENCE=Ref.: 4 2; DETAILS_JSON={"cas_number":"68259-00-7","citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","duration":"","effect":"he substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated with vehicle. A complete block de","endpoint":"repeated dose toxicity","ingredient":"1-methyl-4-((methylphenylhydrazono)methyl)-pyridinium, methylsulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"39","page":6,"route":"dermal","species":"guinea pig","study_id":"out238_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 60 | mg/kg bw | rabbit | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=out238_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING Basic Yellow 87; OPINION_NUMBER=SCCNFP/0730/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=60; DOSE=A repeated dose oral and dermal toxicity study were performed.; EFFECT=0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 18 Results No reactions were observed on both the irradiated and non-irradiated flanks of test and control animals. Ref.: 10 2.11. Safety evaluation Not applicable 2.12. Conclusions No experimental data is provided on stability of the test material. A repeated dose oral and dermal toxicity study were performed. The NOAEL in a subchronic toxicity study was set at 10 mg/kg bw/day. The NOAEL for maternal and foetal toxicity was set at 60 mg/kg bw. Basic Yellow 87 was not irritating to rabbit skin. It was moderately irritating to rabbit eye under the test conditions. In a guinea pig maximization test Basic Yellow 87 was not a sensitizer under the test conditions. The total percutaneous absorption amounted to 0.16 +/- 0.031 µg/cm². The percutaneous absorption of Basic Yellow 87 has not been tested in the presence of an oxidising agent. Basic Yellow 87 showed phototoxic potential in the guinea pigs at; CITATION=Ref.: 10 2; CITATION_NUMBERS=[10,2]; REFERENCE=Ref.: 10 2; DETAILS_JSON={"cas_number":"68259-00-7","citation":"Ref.: 10 2","dose":"A repeated dose oral and dermal toxicity study were performed.","duration":"subchronic","effect":"0730/03 Opinion on Basic Yellow 87 _____________________________________________________________________________________________ 18 Results No reactions were observed on both the irradiated and non-irradiated flanks of test and control animals. Ref.: 10 2.11. Safety evaluation Not applicable 2.12. Conclusions No experimental data is provided on stability of the test material. A repeated dose oral and dermal toxicity study were performed. The NOAEL in a subchronic toxicity study was set at 10 mg/kg bw/day. The NOAEL for maternal and foetal toxicity was set at 60 mg/kg bw. Basic Yellow 87 was not irritating to rabbit skin. It was moderately irritating to rabbit eye under the test conditions. In a guinea pig maximization test Basic Yellow 87 was not a sensitizer under the test conditions. The total percutaneous absorption amounted to 0.16 +/- 0.031 µg/cm². The percutaneous absorption of Basic Yellow 87 has not been tested in the presence of an oxidising agent. Basic Yellow 87 showed phototoxic potential in the guinea pigs at","endpoint":"repeated dose toxicity","ingredient":"1-methyl-4-((methylphenylhydrazono)methyl)-pyridinium, methylsulfate","loael_value":"","noael_unit":"mg/kg bw","noael_value":"60","page":18,"route":"oral","species":"rabbit","study_id":"out238_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 174 | mg/kg bw/day | guinea pig | dermal | - | repeated dose toxicity | SOURCE_SUBDIR=out238_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING Basic Yellow 87; OPINION_NUMBER=SCCNFP/0730/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=174; DOSE=In high dose males the food intake and the mean body weight and body weight gain was slightly lower.; EFFECT=rved in all animals receiving the substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated wit; CITATION=Ref.: 4 2; CITATION_NUMBERS=[4,2]; REFERENCE=Ref.: 4 2; DETAILS_JSON={"cas_number":"68259-00-7","citation":"Ref.: 4 2","dose":"In high dose males the food intake and the mean body weight and body weight gain was slightly lower.","duration":"","effect":"rved in all animals receiving the substance. There were no effects on haematology, clinical biochemistry and urinalysis that were considered of toxicological significance. The functional observational battery did not reveal abnormal test article related findings. In high dose males the food intake and the mean body weight and body weight gain was slightly lower. A slightly reduced total protein and globulin level and a slightly increased albumin to globulin ratio were recorded in males of the high dose group. The NOAEL is 174 mg/kg bw/day, the NOEL approximately 39 mg/kg bw/day. Ref.: 4 2.3.5 Repeated dose dermal toxicity Guideline : OECD 402 (1987) Species/strain : Himalayan spotted guinea pigs Group size : 4 males, 4 females Test substance : MIP 2982 Batch number : CGF-FO16737/0016 Purity : >92% Dose levels : 0.1 ml/7 cm2, 4 concentrations 5%, 3%, 1% and 0.5% GLP : In compliance Two applications sites of 7 cm2 were marked on the shaved back of 6 test article treated animals. Two animals were controlled and treated wit","endpoint":"repeated dose toxicity","ingredient":"1-methyl-4-((methylphenylhydrazono)methyl)-pyridinium, methylsulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"174","page":6,"route":"dermal","species":"guinea pig","study_id":"out238_en_noael_001"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 224I63D8K4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H16N3.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"224I63D8K4"} |
| openFDA substances | FDA UNII substance identifier | 224I63D8K4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H16N3.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"224I63D8K4"} |
| openFDA substances | FDA UNII substance identifier | 224I63D8K4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H16N3.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"224I63D8K4"} |
| openFDA substances | FDA UNII substance identifier | 224I63D8K4 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H16N3.CH3O4S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"224I63D8K4"} |