NOAEL Studies Cosmetic Ingredient

Basic Red 76 NOAEL Studies

CAS: 68391-30-0

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 60 mg/kg bw/day rat oral 90 day Subchronic SCCS; van Otterdijk, F.M. Repeated dose 90-day oral toxicity study with C 008 bydaily gavage in the rat followed by a 28-day recovery period.NOTOX B.V., s’Hertogenbosch,Report No. R 0500465
SCCNFP_vision_codex 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =200 mg/kg bw/day rat oral 5 days NOAEL study {"citation":"Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red","dose":"Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels.","effect":"SCCNFP/0661/03, final Evaluation and opinion on : Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels. The NOAEL was reported to be lower than 200 mg/kg bw/day. Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red in aqueous solution Batch no : 1077 (purity not stated) Dose levels : 0 and 20 mg/kg bw in a volume of 10 ml/kg Exposure : 5 days per week for 13 weeks by gavage GLP : in compliance Commercial Arianor Madder Red, in aqueous solution, was administered by oral gavage daily, 5 days per","page":7,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_001"}
SCCNFP_vision_codex NOAEL >98 % mouse dermal - carcinogenicity {"citation":"Ref. : 17 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...","effect":"the mouse exposed to the test material for one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% ino","page":17,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_002"}
SCCNFP_vision_codex NOAEL =200 mg/kg bw/day rat oral 5 days NOAEL study {"citation":"Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red","dose":"Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels.","effect":"SCCNFP/0661/03, final Evaluation and opinion on : Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels. The NOAEL was reported to be lower than 200 mg/kg bw/day. Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red in aqueous solution Batch no : 1077 (purity not stated) Dose levels : 0 and 20 mg/kg bw in a volume of 10 ml/kg Exposure : 5 days per week for 13 weeks by gavage GLP : in compliance Commercial Arianor Madder Red, in aqueous solution, was administered by oral gavage daily, 5 days per","page":7,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_001"}
SCCNFP_vision_codex NOAEL >98 % mouse dermal - carcinogenicity {"citation":"Ref. : 17 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...","effect":"the mouse exposed to the test material for one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% ino","page":17,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_002"}
SCCNFP_vision_codex NOAEL =200 mg/kg bw/day rat oral 5 days NOAEL study {"citation":"Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red","dose":"Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels.","effect":"SCCNFP/0661/03, final Evaluation and opinion on : Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels. The NOAEL was reported to be lower than 200 mg/kg bw/day. Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red in aqueous solution Batch no : 1077 (purity not stated) Dose levels : 0 and 20 mg/kg bw in a volume of 10 ml/kg Exposure : 5 days per week for 13 weeks by gavage GLP : in compliance Commercial Arianor Madder Red, in aqueous solution, was administered by oral gavage daily, 5 days per","page":7,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_001"}
SCCNFP_vision_codex NOAEL >98 % mouse dermal - carcinogenicity {"citation":"Ref. : 17 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...","effect":"the mouse exposed to the test material for one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% ino","page":17,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_002"}
SCCNFP_vision_codex NOAEL =200 mg/kg bw/day rat oral 5 days NOAEL study {"citation":"Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red","dose":"Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels.","effect":"SCCNFP/0661/03, final Evaluation and opinion on : Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels. The NOAEL was reported to be lower than 200 mg/kg bw/day. Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red in aqueous solution Batch no : 1077 (purity not stated) Dose levels : 0 and 20 mg/kg bw in a volume of 10 ml/kg Exposure : 5 days per week for 13 weeks by gavage GLP : in compliance Commercial Arianor Madder Red, in aqueous solution, was administered by oral gavage daily, 5 days per","page":7,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_001"}
SCCNFP_vision_codex NOAEL >98 % mouse dermal - carcinogenicity {"citation":"Ref. : 17 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...","effect":"the mouse exposed to the test material for one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% ino","page":17,"pdf":"out_197.pdf","row_type":"noael_study","study_id":"out_197_noael_002"}
SCCS_vision_codex 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.","effect":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for","page":16,"pdf":"sccs_o_051.pdf","row_type":"noael_study","study_id":"sccs_o_051_noael_001"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.","effect":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for","page":16,"pdf":"sccs_o_051.pdf","row_type":"noael_study","study_id":"sccs_o_051_noael_001"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.","effect":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for","page":16,"pdf":"sccs_o_051.pdf","row_type":"noael_study","study_id":"sccs_o_051_noael_001"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day - - - NOAEL study {"citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.","effect":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for","page":16,"pdf":"sccs_o_051.pdf","row_type":"noael_study","study_id":"sccs_o_051_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies - 200 mg/kg bw/day rat oral 5 days - SOURCE_SUBDIR=out_197; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 76 COLIPA n° C8; OPINION_NUMBER=SCCNFP/0661/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=200; DOSE=Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels.; EFFECT=SCCNFP/0661/03, final Evaluation and opinion on : Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels. The NOAEL was reported to be lower than 200 mg/kg bw/day. Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red in aqueous solution Batch no : 1077 (purity not stated) Dose levels : 0 and 20 mg/kg bw in a volume of 10 ml/kg Exposure : 5 days per week for 13 weeks by gavage GLP : in compliance Commercial Arianor Madder Red, in aqueous solution, was administered by oral gavage daily, 5 days per; CITATION=Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red; CITATION_NUMBERS=[7,2,408,1981,10,5]; REFERENCE=Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red","dose":"Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels.","duration":"5 days","effect":"SCCNFP/0661/03, final Evaluation and opinion on : Basic Red 76 ____________________________________________________________________________________________ 7 No differences between control and treated animals were observed at either the macroscopic or histopathological levels. The NOAEL was reported to be lower than 200 mg/kg bw/day. Ref. : 7 Study 2 Guideline : OECD 408 (1981) Species : Sprague Dawley CD rat Route : oral Group sizes : 10 male and 10 female + 5/5 recovery Material : Commercial grade Arianor Madder Red in aqueous solution Batch no : 1077 (purity not stated) Dose levels : 0 and 20 mg/kg bw in a volume of 10 ml/kg Exposure : 5 days per week for 13 weeks by gavage GLP : in compliance Commercial Arianor Madder Red, in aqueous solution, was administered by oral gavage daily, 5 days per","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":7,"route":"oral","species":"rat","study_id":"out_197_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies carcinogenicity >98 % mouse dermal - carcinogenicity SOURCE_SUBDIR=out_197; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 76 COLIPA n° C8; OPINION_NUMBER=SCCNFP/0661/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=>98; DOSE=Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...; EFFECT=the mouse exposed to the test material for one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% ino; CITATION=Ref. : 17 2; CITATION_NUMBERS=[17,2]; REFERENCE=Ref. : 17 2; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref. : 17 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...","duration":"","effect":"the mouse exposed to the test material for one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% ino","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":">98","page":17,"route":"dermal","species":"mouse","study_id":"out_197_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies carcinogenicity >98 % human dermal - carcinogenicity SOURCE_SUBDIR=out_197; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 76 COLIPA n° C8; OPINION_NUMBER=SCCNFP/0661/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=>98; DOSE=Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...; EFFECT=r one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% inorganic salts.; CITATION=Ref. : 17 2; CITATION_NUMBERS=[17,2]; REFERENCE=Ref. : 17 2; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref. : 17 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...","duration":"","effect":"r one hour clearly showed a high radioactivity in the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% inorganic salts.","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":">98","page":17,"route":"dermal","species":"human","study_id":"out_197_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies carcinogenicity >98 % human dermal - carcinogenicity SOURCE_SUBDIR=out_197; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BASIC RED 76 COLIPA n° C8; OPINION_NUMBER=SCCNFP/0661/03; COMMITTEE=SCCNFP; REPORT_DATE=18 March 2003; VALUE_TEXT=>98; DOSE=Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...; EFFECT=n the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% inorganic salts. A complete description of the sugar and salts is; CITATION=Ref. : 17 2; CITATION_NUMBERS=[17,2]; REFERENCE=Ref. : 17 2; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref. : 17 2","dose":"Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic...","duration":"","effect":"n the gall bladder. Ref. : 17 2.11. Safety evaluation NOT APPLICABLE CALCULATION OF THE MARGIN OF SAFETY (Basic Red 76) (Direct Hair Dyes) Based on a usage volume of 35 ml, containing at maximum Maximum absorption through the skin A (µg/cm2) = µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = cm2 Dermal absorption per treatment SAS x A x 0.001 = mg Systemic exposure dose (SED) SAS x A x 0.001/60 = mg/kg No observed adverse effect level (mg/kg) NOAEL = mg/kg (species, study) Margin of Safety NOAEL / SED = 2.12. Conclusions Commercial grade dye of different batches has been used for various tests, but purity (>98%) of the dye has been described only in one case. The impurities in the dye should be described. The test substance is an azo-dye, therefore, free aromatic amine (2-methoxy aniline) content in the dye (in all batches) are required for the evaluation of carcinogenic potential of the dye. The dye formulation contains 16% sugar and 14.5% inorganic salts. A complete description of the sugar and salts is","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":">98","page":17,"route":"dermal","species":"human","study_id":"out_197_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 60 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.; EFFECT=y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for; CITATION=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; CITATION_NUMBERS=[13,60]; REFERENCE=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.","duration":"","effect":"y evidence for haemolysis and increased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for","endpoint":"","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":16,"route":"","species":"","study_id":"sccs_o_051_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 60 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=eased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.; EFFECT=eased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for Basic R; CITATION=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; CITATION_NUMBERS=[13,60]; REFERENCE=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"eased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin.","duration":"","effect":"eased methaemoglobin levels at these dose levels, which indicate a direct adverse effect of the test substance on haemoglobin. At 60 mg/kg bw/day, evidence for an effect on red blood cell turn over was marginal in nature and occurred in the absence of any evidence of red blood cell destruction or increased extramedullary haematopoiesis, and was considered not to reflect an adverse effect on red blood cell turn over. Therefore, from the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for Basic R","endpoint":"","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":16,"route":"","species":"","study_id":"sccs_o_051_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 60 mg/kg bw/day - - prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).; EFFECT=slightly above the historical control range are considered to be of no toxicological significance. Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.; CITATION=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; CITATION_NUMBERS=[15,76,60,250]; REFERENCE=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day","dose":"Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).","duration":"prenatal","effect":"slightly above the historical control range are considered to be of no toxicological significance. Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.","endpoint":"developmental toxicity","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":21,"route":"","species":"","study_id":"sccs_o_051_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 60 mg/kg bw/day - - prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).; EFFECT=rol range are considered to be of no toxicological significance. Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.; CITATION=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; CITATION_NUMBERS=[15,76,60,250]; REFERENCE=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day","dose":"Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).","duration":"prenatal","effect":"rol range are considered to be of no toxicological significance. Based on available data in this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.","endpoint":"developmental toxicity","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":21,"route":"","species":"","study_id":"sccs_o_051_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 60 mg/kg bw/day - - prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).; EFFECT=this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.; CITATION=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; CITATION_NUMBERS=[15,76,60,250]; REFERENCE=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day","dose":"this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).","duration":"prenatal","effect":"this study, no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.","endpoint":"developmental toxicity","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":21,"route":"","species":"","study_id":"sccs_o_051_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 60 mg/kg bw/day - - prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).; EFFECT=some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.; CITATION=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; CITATION_NUMBERS=[15,76,60,250]; REFERENCE=Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day","dose":"some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day).","duration":"prenatal","effect":"some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the mid dose level (250 mg/kg bw/day) when compared to the high dose level (1000 mg/kg bw/day). In conclusion, based on the results in this prenatal developmental toxicity study, the maternal No-Observed-Adverse-Effect-Level (NOAEL) was established as being 60 mg/kg bw/day. The developmental No-Observed-Effect-Level NOEL was considered to be 60 mg/kg bw/day. Ref.: 15 Comment The NOAEL of developmental toxicity in this study for Basic Red 76 is considered 60 mg/kg bw/day due to reduction in foetal body weight at 250 mg/kg bw/day.","endpoint":"developmental toxicity","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":21,"route":"","species":"","study_id":"sccs_o_051_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 60 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established.; EFFECT=a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for Basic Red 76 cannot be established and the dose of 60 mg/kg bw/day is considered a LOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments Test substance: C 008 Solvent: DMSO Batch nr: 0057891101 Purity: 98.6 area% Concent; CITATION=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; CITATION_NUMBERS=[13,60]; REFERENCE=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established.","duration":"Chronic","effect":"a definitive No Observed Adverse Effect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for Basic Red 76 cannot be established and the dose of 60 mg/kg bw/day is considered a LOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments Test substance: C 008 Solvent: DMSO Batch nr: 0057891101 Purity: 98.6 area% Concent","endpoint":"genotoxicity","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":16,"route":"","species":"","study_id":"sccs_o_051_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 60 mg/kg bw/day - - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=ffect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established.; EFFECT=ffect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for Basic Red 76 cannot be established and the dose of 60 mg/kg bw/day is considered a LOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments Test substance: C 008 Solvent: DMSO Batch nr: 0057891101 Purity: 98.6 area% Concentration:; CITATION=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; CITATION_NUMBERS=[13,60]; REFERENCE=Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma; DETAILS_JSON={"cas_number":"68391-30-0","citation":"Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in ma","dose":"ffect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established.","duration":"Chronic","effect":"ffect Level (NOAEL) for Basic Red 76 of 60 mg/kg bw/day was established. Ref.: 13 Comment Also at 60 mg/kg bw/day, the lowest dose investigated, an early indication for an effect on red blood cell turn over was observed (decreased red blood cells counts in males, decreased haemoglobin levels in both sexes, decreased haematocrit levels in males, decreased mean corpuscular haemoglobin concentration in females). Therefore, the SCCS is of the opinion that from the results presented a No Observed Adverse Effect Level (NOAEL) for Basic Red 76 cannot be established and the dose of 60 mg/kg bw/day is considered a LOAEL. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in 2 individual experiments Test substance: C 008 Solvent: DMSO Batch nr: 0057891101 Purity: 98.6 area% Concentration:","endpoint":"genotoxicity","ingredient":"Basic Red 76","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":16,"route":"","species":"","study_id":"sccs_o_051_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 60 mg/kg bw/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_051; REPORT_TITLE=OPINION ON Basic Red 76 COLIPA n° C8; OPINION_NUMBER=SCCS/1385/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=21 June 2011; VALUE_TEXT=60; DOSE=SCCS/1385/10 Opinion on Basic Red 76 __________________________________________________________________________________ 23 General toxicity The oral LD50-value of Basic Red 76 in Wistar rats was established to exceed 2000 mg/kg bw.; LOAEL_VALUE=60 mg/kg bw/day; EFFECT=SCCS/1385/10 Opinion on Basic Red 76 __________________________________________________________________________________ 23 General toxicity The oral LD50-value of Basic Red 76 in Wistar rats was established to exceed 2000 mg/kg bw. In a subchronic toxicity study, treatment by oral gavage, in rats a LOAEL of 60 mg/kg bw/day was determined due to haemato-toxicity. In a prenatal developmental toxicity study in rats, the maternal and the developmental NOAEL were both established as being 60 mg/kg bw/day. No data on reproductive toxicity were submitted. Irritation, sensitisation Under the conditions of the study, the undiluted test substance was not irritating to rabbit skin. The red staining of the skin may have masked signs of erythema caused by semi- occlusive application of neat Basic Red 76 on the skin of the rabbit. Undiluted Basic Red 76 was irritating to rabbit eyes. The sensitising potential of Basic Red 76 has not been excluded, as only concentrations up t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68391-30-0","citation":"","dose":"SCCS/1385/10 Opinion on Basic Red 76 __________________________________________________________________________________ 23 General toxicity The oral LD50-value of Basic Red 76 in Wistar rats was established to exceed 2000 mg/kg bw.","duration":"subchronic","effect":"SCCS/1385/10 Opinion on Basic Red 76 __________________________________________________________________________________ 23 General toxicity The oral LD50-value of Basic Red 76 in Wistar rats was established to exceed 2000 mg/kg bw. In a subchronic toxicity study, treatment by oral gavage, in rats a LOAEL of 60 mg/kg bw/day was determined due to haemato-toxicity. In a prenatal developmental toxicity study in rats, the maternal and the developmental NOAEL were both established as being 60 mg/kg bw/day. No data on reproductive toxicity were submitted. Irritation, sensitisation Under the conditions of the study, the undiluted test substance was not irritating to rabbit skin. The red staining of the skin may have masked signs of erythema caused by semi- occlusive application of neat Basic Red 76 on the skin of the rabbit. Undiluted Basic Red 76 was irritating to rabbit eyes. The sensitising potential of Basic Red 76 has not been excluded, as only concentrations up t","endpoint":"repeated dose toxicity","ingredient":"Basic Red 76","loael_value":"60 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"60","page":23,"route":"oral","species":"rat","study_id":"sccs_o_051_noael_009"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier ES19W9WI76 UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H22N3O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ES19W9WI76"}
openFDA substances FDA UNII substance identifier ES19W9WI76 UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H22N3O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ES19W9WI76"}
openFDA substances FDA UNII substance identifier ES19W9WI76 UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H22N3O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ES19W9WI76"}
openFDA substances FDA UNII substance identifier ES19W9WI76 UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H22N3O2.Cl","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"ES19W9WI76"}