NOAEL Studies
Cosmetic Ingredient
FD&C Yellow No. 5 (CI 19140) NOAEL Studies
INCI: FD&C YELLOW NO. 5
CAS: 1934-21-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 21 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 792 | mg/kg bw/day | mouse | oral | 2 year | Chronic | PAFA; CAP |
| COSMOS_DB | LOAEL | 8919 | mg/kg bw/day | mouse | oral | 2 year | Chronic | PAFA; FOOD CHEM TOXICOL 26:189-194 |
| COSMOS_DB | LOAEL | 53 | mg/kg bw/day | rat | oral | 2 year | Chronic | PAFA; FOOD CHEM TOXICOL 26:179-187 |
| COSMOS_DB | NOAEL | 750 | mg/kg bw/day | rat | oral | 448 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1000 | mg/kg bw/day | rabbit | oral | 29 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2500 | mg/kg bw/day | rat | oral | 730 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1500 | mg/kg bw/day | dog | oral | 730 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2641 | mg/kg bw/day | rat | oral | 875 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 984 | mg/kg bw/day | rat | oral | 798 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 7500 | mg/kg bw/day | mouse | oral | 730 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 5000 | mg/kg bw/day | rat | oral | 91 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2190 | mg/kg bw/day | rat | oral | 728 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1105 | mg/kg bw/day | rat | oral | 798 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2995 | mg/kg bw/day | rat | oral | 875 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 8919 | mg/kg bw/day | mouse | oral | 728 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 500 | mg/kg bw/day | rat | oral | 125 day | Neurotoxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1064 | mg/kg bw/day | rat | oral | 20 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 773 | mg/kg bw/day | mouse | oral | 117 day | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2418 | mg/kg bw/day | mouse | oral | 2 year | Chronic | PAFA; FOOD CHEM TOXICOL 26:189-194 |
| COSMOS_DB | NOAEL | 15 | mg/kg bw/day | rat | oral | 30 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 7.5 | mg/kg bw/day | rat | oral | 322 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =984 | mg/kg bw/day | Rat | - | - | chronic/long term toxicity | EFSA FEEDAP - 2016 - OutputID 2877 - body weight - systemic - Safety and efficacy of tartrazine (E 102) for cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents - doi:10.2903/j.efsa.2016.4613 |
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | <=7.5 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2009 - OutputID 395 - Consumers - Scientific Opinion on the re-evaluation Tartrazine (E 102) - doi:10.2903/j.efsa.2009.1331 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | <=10 | mg/kg bw/day | Consumers | - | - | ADI | EFSA FEEDAP - 2016 - OutputID 2877 - Consumers - Safety and efficacy of tartrazine (E 102) for cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents - doi:10.2903/j.efsa.2016.4613 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | <=7.5 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2009 - OutputID 395 - Consumers - Scientific Opinion on the re-evaluation Tartrazine (E 102) - doi:10.2903/j.efsa.2009.1331 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | <=10 | mg/kg bw/day | Consumers | - | - | ADI | EFSA FEEDAP - 2016 - OutputID 2877 - Consumers - Safety and efficacy of tartrazine (E 102) for cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents - doi:10.2903/j.efsa.2016.4613 |
NTP_ICE_acute_oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | >2000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_3747; row=2223; data_type=In Vivo; mixture=Chemical; chemical_name=FD&C Yellow 5; preferred_name=C.I. Acid Yellow 23; dtxsid=DTXSID1021455; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1021455; source_file=acute_oral.xlsx |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=6066; RecordID=ARPathway2016_966; DatasetName=ARPathway2016; DTXSID=DTXSID1021455; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1021455 |
SCCNFP_vision_codex 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =5 | % | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 2","dose":"No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.","effect":"SCCNFP/0786/04 Evaluation and opinion on Acid Yellow 23 _____________________________________________________________________________________________ 7 of the 5 % group animals that died during the experiment. No information was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in m","page":7,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg/day | rat | oral | - | NOAEL study | {"citation":"Ref.: 7 Mated, sperm-positive female rats were dosed with 0","dose":"The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization.","effect":"e-related differences between treatment groups and control group were noted in behaviour, external maternal findings, and body weight. The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization. No dose- related changes were observed in pregnancy rate, implantation efficiency, maternal findings, foetal viability or foetal development. Examination of offspring for external and skeletal variations revealed no dose-related increase of incidence. The NOAEL for teratogenicity of Acid Yellow 23 was > 1000 mg/kg/day in this study. The study is regarded as valid and relevant for risk assessment, as a sufficient number of animals and relevant endpoints were examined. Ref.: 7 Mated, sperm-positive female rats were dosed with 0.05, 0.1, 0.2, 0.4, or 0.7 % in drinking water (equivalent to 67 –1064 mg/kg/ day) with Acid Yellow 23, from GD 0 to 19. No unusual behaviour or remarkable external maternal findings were noted. Mean daily food consumption and body weight gain wer","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >0.7 | % | rat | oral | chronic | reproductive toxicity | {"citation":"Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23","dose":"A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups.","effect":"able external maternal findings were noted. Mean daily food consumption and body weight gain were similar in all groups. A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups. No dose-related changes were observed in pregnancy rate, implantation efficiency, foetal viability or foetal development. Reproductive findings at necropsy were unremarkable. Examination of offspring for external, skeletal and soft tissue variations revealed no dose-related increase of incidence. The NOAEL for teratogenic toxicity of Acid Yellow 23 was > 0.7% corresponding to 1064 mg/kg/day based on the mean fluid consumption in this study. A sufficient number of animals was regarded and relevant endpoints were examined. The study is judged as valid and relevant for risk assessment. Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 2","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =2640 | mg/kg | rat | oral | - | carcinogenicity | {"citation":"Ref.: 29 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...","effect":"d not demonstrate carcinogenic effects. Ref.: 29 Human studies No data. 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not consider","page":20,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =5 | % | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 2","dose":"No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.","effect":"SCCNFP/0786/04 Evaluation and opinion on Acid Yellow 23 _____________________________________________________________________________________________ 7 of the 5 % group animals that died during the experiment. No information was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in m","page":7,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg/day | rat | oral | - | NOAEL study | {"citation":"Ref.: 7 Mated, sperm-positive female rats were dosed with 0","dose":"The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization.","effect":"e-related differences between treatment groups and control group were noted in behaviour, external maternal findings, and body weight. The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization. No dose- related changes were observed in pregnancy rate, implantation efficiency, maternal findings, foetal viability or foetal development. Examination of offspring for external and skeletal variations revealed no dose-related increase of incidence. The NOAEL for teratogenicity of Acid Yellow 23 was > 1000 mg/kg/day in this study. The study is regarded as valid and relevant for risk assessment, as a sufficient number of animals and relevant endpoints were examined. Ref.: 7 Mated, sperm-positive female rats were dosed with 0.05, 0.1, 0.2, 0.4, or 0.7 % in drinking water (equivalent to 67 –1064 mg/kg/ day) with Acid Yellow 23, from GD 0 to 19. No unusual behaviour or remarkable external maternal findings were noted. Mean daily food consumption and body weight gain wer","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >0.7 | % | rat | oral | chronic | reproductive toxicity | {"citation":"Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23","dose":"A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups.","effect":"able external maternal findings were noted. Mean daily food consumption and body weight gain were similar in all groups. A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups. No dose-related changes were observed in pregnancy rate, implantation efficiency, foetal viability or foetal development. Reproductive findings at necropsy were unremarkable. Examination of offspring for external, skeletal and soft tissue variations revealed no dose-related increase of incidence. The NOAEL for teratogenic toxicity of Acid Yellow 23 was > 0.7% corresponding to 1064 mg/kg/day based on the mean fluid consumption in this study. A sufficient number of animals was regarded and relevant endpoints were examined. The study is judged as valid and relevant for risk assessment. Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 2","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =2640 | mg/kg | rat | oral | - | carcinogenicity | {"citation":"Ref.: 29 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...","effect":"d not demonstrate carcinogenic effects. Ref.: 29 Human studies No data. 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not consider","page":20,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =5 | % | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 2","dose":"No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.","effect":"SCCNFP/0786/04 Evaluation and opinion on Acid Yellow 23 _____________________________________________________________________________________________ 7 of the 5 % group animals that died during the experiment. No information was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in m","page":7,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg/day | rat | oral | - | NOAEL study | {"citation":"Ref.: 7 Mated, sperm-positive female rats were dosed with 0","dose":"The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization.","effect":"e-related differences between treatment groups and control group were noted in behaviour, external maternal findings, and body weight. The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization. No dose- related changes were observed in pregnancy rate, implantation efficiency, maternal findings, foetal viability or foetal development. Examination of offspring for external and skeletal variations revealed no dose-related increase of incidence. The NOAEL for teratogenicity of Acid Yellow 23 was > 1000 mg/kg/day in this study. The study is regarded as valid and relevant for risk assessment, as a sufficient number of animals and relevant endpoints were examined. Ref.: 7 Mated, sperm-positive female rats were dosed with 0.05, 0.1, 0.2, 0.4, or 0.7 % in drinking water (equivalent to 67 –1064 mg/kg/ day) with Acid Yellow 23, from GD 0 to 19. No unusual behaviour or remarkable external maternal findings were noted. Mean daily food consumption and body weight gain wer","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >0.7 | % | rat | oral | chronic | reproductive toxicity | {"citation":"Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23","dose":"A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups.","effect":"able external maternal findings were noted. Mean daily food consumption and body weight gain were similar in all groups. A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups. No dose-related changes were observed in pregnancy rate, implantation efficiency, foetal viability or foetal development. Reproductive findings at necropsy were unremarkable. Examination of offspring for external, skeletal and soft tissue variations revealed no dose-related increase of incidence. The NOAEL for teratogenic toxicity of Acid Yellow 23 was > 0.7% corresponding to 1064 mg/kg/day based on the mean fluid consumption in this study. A sufficient number of animals was regarded and relevant endpoints were examined. The study is judged as valid and relevant for risk assessment. Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 2","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =2640 | mg/kg | rat | oral | - | carcinogenicity | {"citation":"Ref.: 29 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...","effect":"d not demonstrate carcinogenic effects. Ref.: 29 Human studies No data. 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not consider","page":20,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =5 | % | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 2 2","dose":"No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.","effect":"SCCNFP/0786/04 Evaluation and opinion on Acid Yellow 23 _____________________________________________________________________________________________ 7 of the 5 % group animals that died during the experiment. No information was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in m","page":7,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | >1000 | mg/kg/day | rat | oral | - | NOAEL study | {"citation":"Ref.: 7 Mated, sperm-positive female rats were dosed with 0","dose":"The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization.","effect":"e-related differences between treatment groups and control group were noted in behaviour, external maternal findings, and body weight. The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization. No dose- related changes were observed in pregnancy rate, implantation efficiency, maternal findings, foetal viability or foetal development. Examination of offspring for external and skeletal variations revealed no dose-related increase of incidence. The NOAEL for teratogenicity of Acid Yellow 23 was > 1000 mg/kg/day in this study. The study is regarded as valid and relevant for risk assessment, as a sufficient number of animals and relevant endpoints were examined. Ref.: 7 Mated, sperm-positive female rats were dosed with 0.05, 0.1, 0.2, 0.4, or 0.7 % in drinking water (equivalent to 67 –1064 mg/kg/ day) with Acid Yellow 23, from GD 0 to 19. No unusual behaviour or remarkable external maternal findings were noted. Mean daily food consumption and body weight gain wer","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | >0.7 | % | rat | oral | chronic | reproductive toxicity | {"citation":"Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23","dose":"A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups.","effect":"able external maternal findings were noted. Mean daily food consumption and body weight gain were similar in all groups. A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups. No dose-related changes were observed in pregnancy rate, implantation efficiency, foetal viability or foetal development. Reproductive findings at necropsy were unremarkable. Examination of offspring for external, skeletal and soft tissue variations revealed no dose-related increase of incidence. The NOAEL for teratogenic toxicity of Acid Yellow 23 was > 0.7% corresponding to 1064 mg/kg/day based on the mean fluid consumption in this study. A sufficient number of animals was regarded and relevant endpoints were examined. The study is judged as valid and relevant for risk assessment. Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 2","page":13,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =2640 | mg/kg | rat | oral | - | carcinogenicity | {"citation":"Ref.: 29 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...","effect":"d not demonstrate carcinogenic effects. Ref.: 29 Human studies No data. 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not consider","page":20,"pdf":"out260_en.pdf","row_type":"noael_study","study_id":"out260_en_noael_006"} |
ToxValDB_ECHA_IUCLID 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =2641 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9f0e4b0a7c65d1b387d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17292/7/8?documentUUID=34708cf7-8ebc-470f-9040-e36782cd74af; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID:15820383:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_b0592eab777ba369fc6e978bc7961092 |
| ToxValDB_ECHA_IUCLID | NOAEL | =3348 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9f0e4b0a7c65d1b387d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17292/7/8?documentUUID=34708cf7-8ebc-470f-9040-e36782cd74af; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID:15820384:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_f2c3eb756df9b8c8bbeb294b2bfacf42 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1064.3 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbe90; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/12236?documentUUID=99b7317c-4c1d-4b46-8d69-c269b8cd8271; YEAR=2019; ORIGINAL_YEAR=2019; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: changes in number of pregnant|maternal: clinical signs|maternal: food consumption and compound intake|maternal: mortality|maternal: pre and post implantation loss|maternal: water consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|mortality/survival|reproduction; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823302_15823343:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_1edf34afb222063908f415489ca46971 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1064 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac00e4b0a7c65d1bcdb8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17292/7/9/3?documentUUID=34708cf7-8ebc-470f-9040-e36782cd74af; YEAR=1982; ORIGINAL_YEAR=1982; TOXICOLOGICAL_EFFECT=maternal: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823302_15823343:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_31cdf1d175831e0e3bce3de833ef6a4b |
| ToxValDB_ECHA_IUCLID | NOAEL | =642.8 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbe8e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/12236?documentUUID=99b7317c-4c1d-4b46-8d69-c269b8cd8271; YEAR=2019; ORIGINAL_YEAR=2019; STUDY_GROUP=ECHA IUCLID:15823761:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_f990f0ddca26e31dd96603920220ed45 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1000 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac00e4b0a7c65d1bcdb6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17292/7/9/3?documentUUID=34708cf7-8ebc-470f-9040-e36782cd74af; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID:15824572:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_b9437c9f52475c77b2675505c66d1b21 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1250 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadc7e4b0a7c65d1c5f48; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21583/7/6/2?documentUUID=2f5ce440-67ff-4f67-a435-888350d4c19d; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847799_15848283:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_fa18304b6f5bf0ef89424b9781fedd3d |
| ToxValDB_ECHA_IUCLID | NOAEL | ~8103 | mg/kg bw/day | Rat | oral | chronic; 104 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadc7e4b0a7c65d1c5dd6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17292/7/6/2?documentUUID=34708cf7-8ebc-470f-9040-e36782cd74af; YEAR=1982; ORIGINAL_YEAR=1982; TOXICOLOGICAL_EFFECT=mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=ECHA IUCLID:15849247:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_06ff5fa8b4da37951b65c9005c1c4445 |
| ToxValDB_ECHA_IUCLID | NOAEL | ~9735 | mg/kg bw/day | Rat | oral | chronic; 104 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadc7e4b0a7c65d1c5dd6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17292/7/6/2?documentUUID=34708cf7-8ebc-470f-9040-e36782cd74af; YEAR=1982; ORIGINAL_YEAR=1982; TOXICOLOGICAL_EFFECT=mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=ECHA IUCLID:15849248:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_101a8342e47c02be8159bed1898de8d4 |
ToxValDB_ECOTOX 17 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =2 | % | Rat | oral | short-term; 14 days | short-term | LONG_REF=J. Toxicol. Environ. Health2(5): 1211-1220 Sobotka,T.J., R.E. Brodie, and S.L. Spaid Tartrazine and the Developing Nervous System of Rats 1977; TITLE=Tartrazine and the Developing Nervous System of Rats; AUTHOR=Sobotka,T.J., R.E. Brodie, and S.L. Spaid; DOI=10.1080/15287397709529519; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76050; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Biochemistry: Hemoglobin|Cell(s): Red blood cell|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=hematology|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15599257_15599258:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b7095d46c5bdae73100730cf9181839b |
| ToxValDB_ECOTOX | LOEL | =5 | % | Rat | oral | short-term; 14 days | short-term | LONG_REF=J. Nutr.107(5): 822-828 Ershoff,B.H. Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6) 1977; TITLE=Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6); AUTHOR=Ershoff,B.H.; DOI=10.1093/jn/107.5.822; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76051; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Growth: Weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600716_15605647_15605648_15609604:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=914578f5440ebf73ad00347aea5ec93b |
| ToxValDB_ECOTOX | LOEL | =2.5 | % w/v | Rat | oral | chronic; 91 days | chronic | LONG_REF=Food Chem. Toxicol.25(12): 891-896 Maekawa,A., C. Matsuoka, H. Onodera, H. Tanigawa, K. Furuta, J. Kanno, J.J. Jang, Y. Hayashi, and T. Ogiu Lack of Carcinogenicity of Tartrazine (FD and C Yellow No. 5) in the F344 Rat 1987; TITLE=Lack of Carcinogenicity of Tartrazine (FD and C Yellow No. 5) in the F344 Rat; AUTHOR=Maekawa,A., C. Matsuoka, H. Onodera, H. Tanigawa, K. Furuta, J. Kanno, J.J. Jang, Y. Hayashi, and T. Ogiu; DOI=10.1016/0278-6915(87)90281-x; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76017; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603926_15603927:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=2fe6e24d41f99ef73e369e158f6c34e4 |
| ToxValDB_ECOTOX | LOEL | =10 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604354_15604355:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b8f02a3881caf993744eb1f84e658299 |
| ToxValDB_ECOTOX | LOEL | =7.5 | % | Rat | oral | short-term; 14 days | short-term | LONG_REF=J. Nutr.107(5): 822-828 Ershoff,B.H. Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6) 1977; TITLE=Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6); AUTHOR=Ershoff,B.H.; DOI=10.1093/jn/107.5.822; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76051; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Growth: Weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600716_15605647_15605648_15609604:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=d8db789dab10e149e31320e34ae86bde |
| ToxValDB_ECOTOX | LOEL | =1 | % | Rat | oral | subchronic; 49 days | subchronic | LONG_REF=J. Toxicol. Environ. Health2(5): 1211-1220 Sobotka,T.J., R.E. Brodie, and S.L. Spaid Tartrazine and the Developing Nervous System of Rats 1977; TITLE=Tartrazine and the Developing Nervous System of Rats; AUTHOR=Sobotka,T.J., R.E. Brodie, and S.L. Spaid; DOI=10.1080/15287397709529519; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76050; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15610471:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b00bea42e7d9e86daa0bd0afc086ff24 |
| ToxValDB_ECOTOX | LOEL | =589 | mg/kg bw/day | Rat | oral | chronic; 114 weeks | chronic | LONG_REF=- | Food Chem. Toxicol.26(3): 179-187 Borzelleca,J.F., and J.B. Hallagan Chronic Toxicity/Carcinogenicity Studies of FD & C Yellow No. 5 (Tartrazine) in Rats 1988; TITLE=Chronic Toxicity/Carcinogenicity Studies of FD & C Yellow No. 5 (Tartrazine) in Rats; AUTHOR=Borzelleca,J.F., and J.B. Hallagan; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76020; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1988; ORIGINAL_YEAR=1988; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15613109:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=04969d91ae29fa0491f61e689329cd11 |
| ToxValDB_ECOTOX | LOEL | =100 | ppm | Rat | injection | chronic; 273.96 days | chronic | LONG_REF=- | Cytobios62(249): 111-117 Giri,A.K., S.K. Das, G. Talukder, and A. Sharma Sister Chromatid Exchange and Chromosome Aberrations Induced by Curcumin and Tartrazine on Mammalian Cells In Vivo 1990; TITLE=Sister Chromatid Exchange and Chromosome Aberrations Induced by Curcumin and Tartrazine on Mammalian Cells In Vivo; AUTHOR=Giri,A.K., S.K. Das, G. Talukder, and A. Sharma; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76048; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=Genetics: Chromosomal aberrations, sister chromatid exchanges; STUDY_GROUP=ECOTOX:15613440:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=2a9c05c71a1b0af9d8a894e5c48e751b |
| ToxValDB_ECOTOX | NOEL | =1 | % | Rat | oral | short-term; 14 days | short-term | LONG_REF=J. Toxicol. Environ. Health2(5): 1211-1220 Sobotka,T.J., R.E. Brodie, and S.L. Spaid Tartrazine and the Developing Nervous System of Rats 1977; TITLE=Tartrazine and the Developing Nervous System of Rats; AUTHOR=Sobotka,T.J., R.E. Brodie, and S.L. Spaid; DOI=10.1080/15287397709529519; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76050; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Biochemistry: Hemoglobin|Cell(s): Red blood cell|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=hematology|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15599257_15599258:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=0e797c201d47be218f7a805984c9d084 |
| ToxValDB_ECOTOX | NOEL | =2 | % w/v | Rat | oral | chronic; 784 days | chronic | LONG_REF=Food Chem. Toxicol.25(12): 891-896 Maekawa,A., C. Matsuoka, H. Onodera, H. Tanigawa, K. Furuta, J. Kanno, J.J. Jang, Y. Hayashi, and T. Ogiu Lack of Carcinogenicity of Tartrazine (FD and C Yellow No. 5) in the F344 Rat 1987; TITLE=Lack of Carcinogenicity of Tartrazine (FD and C Yellow No. 5) in the F344 Rat; AUTHOR=Maekawa,A., C. Matsuoka, H. Onodera, H. Tanigawa, K. Furuta, J. Kanno, J.J. Jang, Y. Hayashi, and T. Ogiu; DOI=10.1016/0278-6915(87)90281-x; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76017; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Injury: Malignant tumor; TOXICOLOGICAL_EFFECT_CATEGORY=cancer; STUDY_GROUP=ECOTOX:15599964:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=61a5c1019f05d253b644edf03cbb5e4d |
| ToxValDB_ECOTOX | NOEL | =2 | % | Rat | oral | short-term; 14 days | developmental | LONG_REF=J. Toxicol. Environ. Health2(5): 1211-1220 Sobotka,T.J., R.E. Brodie, and S.L. Spaid Tartrazine and the Developing Nervous System of Rats 1977; TITLE=Tartrazine and the Developing Nervous System of Rats; AUTHOR=Sobotka,T.J., R.E. Brodie, and S.L. Spaid; DOI=10.1080/15287397709529519; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76050; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Development: Eye opening|Physiology: Neuroresponse|Reproduction: Progeny counts/numbers; TOXICOLOGICAL_EFFECT_CATEGORY=development|neurobehavior|reproduction; STUDY_GROUP=ECOTOX:15600386:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=db305996467c867493de981fb476a038 |
| ToxValDB_ECOTOX | NOEL | =1064.32 | mg/L | Rat | oral | short-term; 20 days | developmental | LONG_REF=Food Chem. Toxicol.30(4): 263-268 Collins,T.F.X., T.N. Black, M.W.,Jr. O\'Donnell, and P. Bulhack Study of the Teratogenic Potential of FD & C Yellow No. 5 when Given in Drinking-Water 1992; TITLE=Study of the Teratogenic Potential of FD & C Yellow No. 5 when Given in Drinking-Water; AUTHOR=Collins,T.F.X., T.N. Black, M.W.,Jr. O\'Donnell, and P. Bulhack; DOI=10.1016/0278-6915(92)90002-3; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76022; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=Development: Abnormal|Feeding behavior: Water consumption; TOXICOLOGICAL_EFFECT_CATEGORY=development|food and/or water consumption; STUDY_GROUP=ECOTOX:15601661:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=20f098e5b2fcd31ab29225d3acc6e1a9 |
| ToxValDB_ECOTOX | NOEL | =1.25 | % w/v | Rat | oral | chronic; 91 days | chronic | LONG_REF=Food Chem. Toxicol.25(12): 891-896 Maekawa,A., C. Matsuoka, H. Onodera, H. Tanigawa, K. Furuta, J. Kanno, J.J. Jang, Y. Hayashi, and T. Ogiu Lack of Carcinogenicity of Tartrazine (FD and C Yellow No. 5) in the F344 Rat 1987; TITLE=Lack of Carcinogenicity of Tartrazine (FD and C Yellow No. 5) in the F344 Rat; AUTHOR=Maekawa,A., C. Matsuoka, H. Onodera, H. Tanigawa, K. Furuta, J. Kanno, J.J. Jang, Y. Hayashi, and T. Ogiu; DOI=10.1016/0278-6915(87)90281-x; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76017; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15603926_15603927:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8f505f81798a68a4b3dc8217732fe2b3 |
| ToxValDB_ECOTOX | NOEL | =1 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604354_15604355:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=993f6a691d6ea110a7cfb077008c075b |
| ToxValDB_ECOTOX | NOEL | =2.5 | % | Rat | oral | short-term; 14 days | short-term | LONG_REF=J. Nutr.107(5): 822-828 Ershoff,B.H. Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6) 1977; TITLE=Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6); AUTHOR=Ershoff,B.H.; DOI=10.1093/jn/107.5.822; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76051; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Growth: Weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15600716_15605647_15605648_15609604:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=a996366425a33816110716bb8bef37d1 |
| ToxValDB_ECOTOX | NOEL | =1800.97 | mg/kg bw/day | Mouse | oral | chronic; 730.56 days | chronic | LONG_REF=- | Food Chem. Toxicol.26(3): 189-194 Borzelleca,J.F., and J.B. Hallagan A Chronic Toxicity/Carcinogenicity Study of FD & C Yellow No. 5 (Tartrazine) in Mice 1988; TITLE=A Chronic Toxicity/Carcinogenicity Study of FD & C Yellow No. 5 (Tartrazine) in Mice; AUTHOR=Borzelleca,J.F., and J.B. Hallagan; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76019; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1988; ORIGINAL_YEAR=1988; TOXICOLOGICAL_EFFECT=Growth: Weight|Mortality: Survival| Haematological parameters: lesions; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|mortality/survival|multiple; STUDY_GROUP=ECOTOX:15613130:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=fdf57dc05da3db642abe775dfbf6bab6 |
| ToxValDB_ECOTOX | NOEL | =1499.06 | mg/kg bw/day | Mouse | oral | chronic; 730.56 days | chronic | LONG_REF=- | Food Chem. Toxicol.26(3): 189-194 Borzelleca,J.F., and J.B. Hallagan A Chronic Toxicity/Carcinogenicity Study of FD & C Yellow No. 5 (Tartrazine) in Mice 1988; TITLE=A Chronic Toxicity/Carcinogenicity Study of FD & C Yellow No. 5 (Tartrazine) in Mice; AUTHOR=Borzelleca,J.F., and J.B. Hallagan; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76019; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1988; ORIGINAL_YEAR=1988; TOXICOLOGICAL_EFFECT=Growth: Weight|Mortality: Survival| Haematological parameters: lesions; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|mortality/survival|multiple; STUDY_GROUP=ECOTOX:15613428:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=43943059a553d4739211a498a379c323 |
ToxValDB_EFSA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EFSA | NOAEL | =984 | mg/kg bw/day | Rat | oral | - | chronic | LONG_REF=EFSA FEEDAP (2016). Safety and efficacy of tartrazine (E 102) for cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents. doi:10.2903/j.efsa.2016.4613.; TITLE=Safety and efficacy of tartrazine (E 102) for cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2016.4613; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15614315:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_fe32cf62c832f1e188a080db8809f56d |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =372.52 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15635049:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b3de98b8eb39513e5c6944260e30c878 |
ToxValDB_HPVIS 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_HPVIS | NOAEL | =5 | % diet | Rat | oral | chronic; 113 weeks | chronic | LONG_REF=Borzelleca J. and Hallagan J. (1988a) A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in rats. Fd Chem Toxic 26, 179-187.; TITLE=A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in rats; AUTHOR=Borzelleca J. and Hallagan J; QUALITY=1; EXTERNAL_SOURCE_ID=62461; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=HPVIS:15639301:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2b62e7008da20ce55ffd8f6c4f608e15 |
| ToxValDB_HPVIS | NOAEL | =8103 | mg/kg bw/day | Mouse | oral | subchronic; 3 months | subchronic | LONG_REF=Borzelleca J. and Hallagan J. (1988b) A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in mice. Fd Chem Toxic 26, 189-194.; TITLE=A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in mice; AUTHOR=Borzelleca J. and Hallagan J; QUALITY=1; EXTERNAL_SOURCE_ID=61453; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=HPVIS:15640245:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_72df1355ad833ccc1e011e18fe24d8b6 |
| ToxValDB_HPVIS | NOAEL | =9753 | mg/kg bw/day | Mouse | oral | subchronic; 3 months | subchronic | LONG_REF=Borzelleca J. and Hallagan J. (1988b) A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in mice. Fd Chem Toxic 26, 189-194.; TITLE=A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in mice; AUTHOR=Borzelleca J. and Hallagan J; QUALITY=1; EXTERNAL_SOURCE_ID=61454; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=HPVIS:15640246:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d1ae46de0df7e480f0098dd58969568c |
| ToxValDB_HPVIS | NOAEL | =2641 | mg/kg bw/day | Rat | oral | chronic; 114 weeks | reproduction developmental | LONG_REF=Borzelleca J. and Hallagan J. (1988a) A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in rats. Fd Chem Toxic 26, 179-187.; TITLE=A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in rats; AUTHOR=Borzelleca J. and Hallagan J; QUALITY=1; EXTERNAL_SOURCE_ID=65358; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480598; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=HPVIS:15643187:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c501a85c6c23e3a024ac82e354894851 |
| ToxValDB_HPVIS | NOAEL | =3348 | mg/kg bw/day | Rat | oral | chronic; 114 weeks | reproduction developmental | LONG_REF=Borzelleca J. and Hallagan J. (1988a) A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in rats. Fd Chem Toxic 26, 179-187.; TITLE=A chronic toxicity/carcinogenicity study of FD & C Yellow No. 5 (Tartazine) in rats; AUTHOR=Borzelleca J. and Hallagan J; QUALITY=1; EXTERNAL_SOURCE_ID=65359; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480598; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=HPVIS:15643188:M:-paternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c3b355d90b659024fa3440a19a059cba |
ToxValDB_WHO_JECFA_ADI 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_WHO_JECFA_ADI | ADI | <=10 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afc40e4b0d99f5a87c0aa; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/477; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=WHO JECFA ADI:15715372:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_eb5e3cc371b5dc63568bd12ef5df6f10 |
UnifiedCodex:SCCNFP:beta.noael_studies 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | >1000 | mg/kg/day | rat | oral | - | - | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=> 1000; DOSE=The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization.; EFFECT=e-related differences between treatment groups and control group were noted in behaviour, external maternal findings, and body weight. The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization. No dose- related changes were observed in pregnancy rate, implantation efficiency, maternal findings, foetal viability or foetal development. Examination of offspring for external and skeletal variations revealed no dose-related increase of incidence. The NOAEL for teratogenicity of Acid Yellow 23 was > 1000 mg/kg/day in this study. The study is regarded as valid and relevant for risk assessment, as a sufficient number of animals and relevant endpoints were examined. Ref.: 7 Mated, sperm-positive female rats were dosed with 0.05, 0.1, 0.2, 0.4, or 0.7 % in drinking water (equivalent to 67 –1064 mg/kg/ day) with Acid Yellow 23, from GD 0 to 19. No unusual behaviour or remarkable external maternal findings were noted. Mean daily food consumption and body weight gain wer; CITATION=Ref.: 7 Mated, sperm-positive female rats were dosed with 0; CITATION_NUMBERS=[7]; REFERENCE=Ref.: 7 Mated, sperm-positive female rats were dosed with 0; DETAILS_JSON={"cas_number":"1934-21-0","citation":"Ref.: 7 Mated, sperm-positive female rats were dosed with 0","dose":"The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization.","duration":"","effect":"e-related differences between treatment groups and control group were noted in behaviour, external maternal findings, and body weight. The mean daily food consumption was significantly higher in the 1000 mg/kg dose group, indicating an effect on food utilization. No dose- related changes were observed in pregnancy rate, implantation efficiency, maternal findings, foetal viability or foetal development. Examination of offspring for external and skeletal variations revealed no dose-related increase of incidence. The NOAEL for teratogenicity of Acid Yellow 23 was > 1000 mg/kg/day in this study. The study is regarded as valid and relevant for risk assessment, as a sufficient number of animals and relevant endpoints were examined. Ref.: 7 Mated, sperm-positive female rats were dosed with 0.05, 0.1, 0.2, 0.4, or 0.7 % in drinking water (equivalent to 67 –1064 mg/kg/ day) with Acid Yellow 23, from GD 0 to 19. No unusual behaviour or remarkable external maternal findings were noted. Mean daily food consumption and body weight gain wer","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg/day","noael_value":"> 1000","page":13,"route":"oral","species":"rat","study_id":"out260_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | carcinogenicity | =2640 | mg/kg | rat | oral | - | carcinogenicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 2640; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...; EFFECT=d not demonstrate carcinogenic effects. Ref.: 29 Human studies No data. 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not consider; CITATION=Ref.: 29 Human studies No data; CITATION_NUMBERS=[29]; REFERENCE=Ref.: 29 Human studies No data; DETAILS_JSON={"cas_number":"1934-21-0","citation":"Ref.: 29 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...","duration":"","effect":"d not demonstrate carcinogenic effects. Ref.: 29 Human studies No data. 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not consider","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 2640","page":20,"route":"oral","species":"rat","study_id":"out260_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | carcinogenicity | =2640 | mg/kg | rat | oral | - | carcinogenicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 2640; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...; EFFECT=. 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not considered maternotoxic or foetotoxic up to 5% in food. No data concerning skin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1934-21-0","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No...","duration":"","effect":". 2.10. Special investigations No data 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent) Maximum absorption through the skin A (µg/cm2) = 13.2 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not considered maternotoxic or foetotoxic up to 5% in food. No data concerning skin","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 2640","page":20,"route":"oral","species":"rat","study_id":"out260_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | carcinogenicity | 5 | % | rat | oral | - | carcinogenicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=5; DOSE=mal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12.; EFFECT=mal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not considered maternotoxic or foetotoxic up to 5% in food. No data concerning skin irritation of Acid Yellow 23 are available. No conclusions from limited reported patch tests are possible. Acid Yellow 23 it is not expected to cause irritant effects following repeated treatment of eyes in a concentration of 3 % in aqueous solution. A guinea pig maximization test pointed to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1934-21-0","citation":"","dose":"mal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12.","duration":"","effect":"mal absorption per treatment SAS x A x 0.001 = 9.24 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.154 mg/kg No observed effect level (mg/kg) NOEL = 2640 mg/kg (rat, carcinogenicity, oral) Margin of Safety NOAEL / SED = 17143 2.12. Conclusions Physical and chemical characterisation The information provided on the compound is largely incomplete and confusing regarding purity and physical constants. The stability data are not acceptable. The basic toxicity data for Acid Yellow 23 is poor. A NOAEL for Acid Yellow 23 was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in male and female rats respectively. Acid Yellow 23 was not considered maternotoxic or foetotoxic up to 5% in food. No data concerning skin irritation of Acid Yellow 23 are available. No conclusions from limited reported patch tests are possible. Acid Yellow 23 it is not expected to cause irritant effects following repeated treatment of eyes in a concentration of 3 % in aqueous solution. A guinea pig maximization test pointed to","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"5","page":20,"route":"oral","species":"rat","study_id":"out260_en_noael_008"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | carcinogenicity | 2640 | mg/kg | rat | oral | - | carcinogenicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=2640; DOSE=No observed effect level (mg/kg) (rat, carcinogenicity, oral) | NOEL | 2640 mg/kg; EFFECT=CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent): No observed effect level (mg/kg) (rat, carcinogenicity, oral) | NOEL | 2640 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1934-21-0","citation":"","dose":"No observed effect level (mg/kg) (rat, carcinogenicity, oral) | NOEL | 2640 mg/kg","duration":"","effect":"CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 23) (Semi-permanent): No observed effect level (mg/kg) (rat, carcinogenicity, oral) | NOEL | 2640 mg/kg","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"2640","page":20,"route":"oral","species":"rat","study_id":"out260_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 5 | % | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=5; DOSE=No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.; EFFECT=SCCNFP/0786/04 Evaluation and opinion on Acid Yellow 23 _____________________________________________________________________________________________ 7 of the 5 % group animals that died during the experiment. No information was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in m; CITATION=Ref.: 2 2; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 2; DETAILS_JSON={"cas_number":"1934-21-0","citation":"Ref.: 2 2","dose":"No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.","duration":"Sub-chronic","effect":"SCCNFP/0786/04 Evaluation and opinion on Acid Yellow 23 _____________________________________________________________________________________________ 7 of the 5 % group animals that died during the experiment. No information was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in m","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"5","page":7,"route":"dermal","species":"","study_id":"out260_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 5 | % | rabbit | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=5; DOSE=No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.; EFFECT=rmation was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in males and females respectively. Ref.: 9, 2, 3 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) No data concerning skin irritation of Acid Yellow 23 are available. No conclusions from limited reported patch tests are possible. 2.4.2. Irritation (mucous membranes) Repeated eye irritation study in rabbits Guideline : / Species : New Zealand White rabbits Group size : 6 of each sex Test substance : Acid Yellow 23; commercial sample; no in; CITATION=Ref.: 2 2; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 2; DETAILS_JSON={"cas_number":"1934-21-0","citation":"Ref.: 2 2","dose":"No NOAEL in mg/kg/day could be derived due to the missing data on water consumption.","duration":"Sub-chronic","effect":"rmation was given on histology of animals at the end of treatment. No NOAEL in mg/kg/day could be derived due to the missing data on water consumption. Ref.: 2 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No chronic study was provided. Several carcinogenicity studies were provided but there were many data gaps. It would seem from these studies that other than coloured fur and faeces there were no dose-related effects from Acid Yellow 23. A NOAEL was derived of 5% in food, equivalent to 2640 and 3348 mg/kg/day in males and females respectively. Ref.: 9, 2, 3 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) No data concerning skin irritation of Acid Yellow 23 are available. No conclusions from limited reported patch tests are possible. 2.4.2. Irritation (mucous membranes) Repeated eye irritation study in rabbits Guideline : / Species : New Zealand White rabbits Group size : 6 of each sex Test substance : Acid Yellow 23; commercial sample; no in","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"5","page":7,"route":"dermal","species":"rabbit","study_id":"out260_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | reproductive toxicity | >0.7 | % | rat | oral | chronic | reproductive toxicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=> 0.7; DOSE=A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups.; EFFECT=able external maternal findings were noted. Mean daily food consumption and body weight gain were similar in all groups. A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups. No dose-related changes were observed in pregnancy rate, implantation efficiency, foetal viability or foetal development. Reproductive findings at necropsy were unremarkable. Examination of offspring for external, skeletal and soft tissue variations revealed no dose-related increase of incidence. The NOAEL for teratogenic toxicity of Acid Yellow 23 was > 0.7% corresponding to 1064 mg/kg/day based on the mean fluid consumption in this study. A sufficient number of animals was regarded and relevant endpoints were examined. The study is judged as valid and relevant for risk assessment. Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 2; CITATION=Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23; CITATION_NUMBERS=[8,2,23]; REFERENCE=Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23; DETAILS_JSON={"cas_number":"1934-21-0","citation":"Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23","dose":"A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups.","duration":"chronic","effect":"able external maternal findings were noted. Mean daily food consumption and body weight gain were similar in all groups. A significant increase in fluid consumption was observed in the 0.2, 0.4, and 0.7 % dose groups. No dose-related changes were observed in pregnancy rate, implantation efficiency, foetal viability or foetal development. Reproductive findings at necropsy were unremarkable. Examination of offspring for external, skeletal and soft tissue variations revealed no dose-related increase of incidence. The NOAEL for teratogenic toxicity of Acid Yellow 23 was > 0.7% corresponding to 1064 mg/kg/day based on the mean fluid consumption in this study. A sufficient number of animals was regarded and relevant endpoints were examined. The study is judged as valid and relevant for risk assessment. Ref.: 8 A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 2","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"> 0.7","page":13,"route":"oral","species":"rat","study_id":"out260_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | reproductive toxicity | 5 | % | rat | oral | 2 months | reproductive toxicity | SOURCE_SUBDIR=out260_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 23 COLIPA n° C29; OPINION_NUMBER=SCCNFP/0786/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=5; DOSE=Slight decreases in body weight (4-5 %), and slight increases in food consumption were noted at the 5.0 % dose group.; EFFECT=was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 23 (0.1, 1.0, 2.0, 5.0 %) for approx. 2 months prior to mating. No treatment-related effects on fertility, gestation, parturition, lactation, pup survival through weaning or number of alive and still-born pups were observed. Slight decreases in body weight (4-5 %), and slight increases in food consumption were noted at the 5.0 % dose group. The NOAEL for reproductive and teratogenic toxicity of Acid Yellow 23 was 5 % in the diet. Ref.: 9 2.7. Toxicokinetics (incl. Percutaneous Absorption) Due to the effects of Acid Yellow 23 following ingestion as a food colorant, it is assumed that intestinal absorption of Acid Yellow 23 occurs. However, no metabolism studies are available. 2.7.1. Percutaneous Absorption in vitro Guideline : OECD Draft Guideline (1996) Species : Pig; CITATION=Ref.: 9 2; CITATION_NUMBERS=[9,2]; REFERENCE=Ref.: 9 2; DETAILS_JSON={"cas_number":"1934-21-0","citation":"Ref.: 9 2","dose":"Slight decreases in body weight (4-5 %), and slight increases in food consumption were noted at the 5.0 % dose group.","duration":"2 months","effect":"was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended with commercial Acid Yellow 23 (0.1, 1.0, 2.0, 5.0 %) for approx. 2 months prior to mating. No treatment-related effects on fertility, gestation, parturition, lactation, pup survival through weaning or number of alive and still-born pups were observed. Slight decreases in body weight (4-5 %), and slight increases in food consumption were noted at the 5.0 % dose group. The NOAEL for reproductive and teratogenic toxicity of Acid Yellow 23 was 5 % in the diet. Ref.: 9 2.7. Toxicokinetics (incl. Percutaneous Absorption) Due to the effects of Acid Yellow 23 following ingestion as a food colorant, it is assumed that intestinal absorption of Acid Yellow 23 occurs. However, no metabolism studies are available. 2.7.1. Percutaneous Absorption in vitro Guideline : OECD Draft Guideline (1996) Species : Pig","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"5","page":13,"route":"oral","species":"rat","study_id":"out260_en_noael_005"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | I753WB2F1M | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H9N4O9S2.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I753WB2F1M"} |
| openFDA substances | FDA UNII substance identifier | I753WB2F1M | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H9N4O9S2.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I753WB2F1M"} |
| openFDA substances | FDA UNII substance identifier | I753WB2F1M | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H9N4O9S2.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I753WB2F1M"} |
| openFDA substances | FDA UNII substance identifier | I753WB2F1M | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H9N4O9S2.3Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I753WB2F1M"} |