NOAEL Studies
Cosmetic Ingredient
CI 45100 NOAEL Studies
CAS: 3520-42-1
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 100 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCP; H.J. Hamann, D. Richard, K. Weber, C.Knuppe, Acid Red 52 (CI 45100): 13-week oral toxicity (gavage) study in rat, RCC Project No. 736334, Itingen /CH |
SCCNFP_vision_codex 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/day | rabbit | oral | 13 weeks | repeated dose toxicity | {"citation":"Ref.: 6 2","dose":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are c...","effect":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Albino-Himalaya rabbits Group size : 6 animals","page":7,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | human | - | - | NOAEL study | {"dose":"Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","effect":"for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation): Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","page":15,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/day | rabbit | oral | 13 weeks | repeated dose toxicity | {"citation":"Ref.: 6 2","dose":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are c...","effect":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Albino-Himalaya rabbits Group size : 6 animals","page":7,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | human | - | - | NOAEL study | {"dose":"Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","effect":"for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation): Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","page":15,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/day | rabbit | oral | 13 weeks | repeated dose toxicity | {"citation":"Ref.: 6 2","dose":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are c...","effect":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Albino-Himalaya rabbits Group size : 6 animals","page":7,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | human | - | - | NOAEL study | {"dose":"Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","effect":"for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation): Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","page":15,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/day | rabbit | oral | 13 weeks | repeated dose toxicity | {"citation":"Ref.: 6 2","dose":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are c...","effect":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Albino-Himalaya rabbits Group size : 6 animals","page":7,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg | human | - | - | NOAEL study | {"dose":"Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","effect":"for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation): Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","page":15,"pdf":"out266_en.pdf","row_type":"noael_study","study_id":"out266_en_noael_004"} |
SCCS_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 6 3","dose":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological...","effect":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0803/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA 98, TA 100); E. coli (WP2uvrA) Test item: Acid Red 52 (CI 45100) Batch: 18882 Purity: ≥ 99% (HPLC, peak area)","page":16,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.013 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_004"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 6 3","dose":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological...","effect":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0803/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA 98, TA 100); E. coli (WP2uvrA) Test item: Acid Red 52 (CI 45100) Batch: 18882 Purity: ≥ 99% (HPLC, peak area)","page":16,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.013 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_004"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 6 3","dose":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological...","effect":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0803/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA 98, TA 100); E. coli (WP2uvrA) Test item: Acid Red 52 (CI 45100) Batch: 18882 Purity: ≥ 99% (HPLC, peak area)","page":16,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.013 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_004"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | - | oral | 13 weeks | genotoxicity | {"citation":"Ref.: 6 3","dose":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological...","effect":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0803/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA 98, TA 100); E. coli (WP2uvrA) Test item: Acid Red 52 (CI 45100) Batch: 18882 Purity: ≥ 99% (HPLC, peak area)","page":16,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =0.013 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rat | oral | 13-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","page":20,"pdf":"sccp_o_137.pdf","row_type":"noael_study","study_id":"sccp_o_137_noael_004"} |
ToxValDB_ECHA_IUCLID 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =1000 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead10e4b0a7c65d1c2568; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/12094?documentUUID=b300c255-029d-42ea-8cad-836bc333cae7; YEAR=1975; ORIGINAL_YEAR=1975; TOXICOLOGICAL_EFFECT=behaviour (functional findings)|organ weights and organ / body weight ratios|urinalysis|body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: non-neoplastic|mortality|ophthalmological examination; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|neurobehavior|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ECHA IUCLID:15836696: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_36816715f00a44eb3b5268beedbb6dac |
ToxValDB_ECOTOX 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | NOEL | =2000 | 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:15598651:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=4e67c3961a62320bf75f3c5765493d2b |
UnifiedCodex:SCCNFP:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | =1000 | mg/kg | human | - | - | - | SOURCE_SUBDIR=out266_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52 COLIPA n° C177; OPINION_NUMBER=SCCNFP/0803/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 1000; DOSE=Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg; EFFECT=for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation): Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3520-42-1","citation":"","dose":"Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","duration":"","effect":"for a semi-permanent hair dye, with a retention factor of 0.1. Absolute worst case calculation (assuming a daily use of 35 ml and a relative density of approximately 1.0 for the hair dye formulation): Maximum absorption through the skin A (%) = 100% Typical body weight of human = 60 kg Daily exposure to hair dye formulation = 35g/day Retention Factor = 0.1 Concentration of dye in the formulation = 0.6% Systemic exposure dose (SED) = 0.35 mg/kg/day No observed effect level (mg/kg) NOAEL = 1000 mg/kg","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 1000","page":15,"route":"","species":"human","study_id":"out266_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 1000 | mg/kg | - | - | - | - | SOURCE_SUBDIR=out266_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52 COLIPA n° C177; OPINION_NUMBER=SCCNFP/0803/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1000; DOSE=No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg; EFFECT=Calculation of the Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3520-42-1","citation":"","dose":"No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","duration":"","effect":"Calculation of the Margin of Safety: No observed effect level (mg/kg) | NOAEL | = | 1000 mg/kg","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":15,"route":"","species":"","study_id":"out266_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 1000 | mg/kg bw/day | pig | - | - | dermal absorption | SOURCE_SUBDIR=out266_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52 COLIPA n° C177; OPINION_NUMBER=SCCNFP/0803/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1000; DOSE=number of implantations and foetuses) of the vehicle control group and the dose groups gave no indication of test article related effects.; EFFECT=number of implantations and foetuses) of the vehicle control group and the dose groups gave no indication of test article related effects. The mean body weights of foetuses, the ratio of male and female foetuses and the results of external, visceral and skeletal examinations of foetuses gave no indication of effects caused by administration of the test article. Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I. 45100) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal organism and the NOEL (no observed effect level) for the foetal organism. Ref.: 8 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Guideline : OECD 428 (1995) Test system : split thickness pig skin (400 µm), 6 samples Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : Acid Red 52, 5 mg/ml in saline pH 3.0 Exp. II : Hair Colour Gel CI L 366I, containing 0.5% Acid Red 52 (pH 2.9 - 3.1) Control : caffeine,; CITATION=Ref.: 8 2; CITATION_NUMBERS=[8,2]; REFERENCE=Ref.: 8 2; DETAILS_JSON={"cas_number":"3520-42-1","citation":"Ref.: 8 2","dose":"number of implantations and foetuses) of the vehicle control group and the dose groups gave no indication of test article related effects.","duration":"","effect":"number of implantations and foetuses) of the vehicle control group and the dose groups gave no indication of test article related effects. The mean body weights of foetuses, the ratio of male and female foetuses and the results of external, visceral and skeletal examinations of foetuses gave no indication of effects caused by administration of the test article. Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I. 45100) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal organism and the NOEL (no observed effect level) for the foetal organism. Ref.: 8 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Guideline : OECD 428 (1995) Test system : split thickness pig skin (400 µm), 6 samples Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : Acid Red 52, 5 mg/ml in saline pH 3.0 Exp. II : Hair Colour Gel CI L 366I, containing 0.5% Acid Red 52 (pH 2.9 - 3.1) Control : caffeine,","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":11,"route":"","species":"pig","study_id":"out266_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 1000 | mg/kg bw/day | pig | - | 3 months | dermal absorption | SOURCE_SUBDIR=out266_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52 COLIPA n° C177; OPINION_NUMBER=SCCNFP/0803/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1000; DOSE=the vehicle control group and the dose groups gave no indication of test article related effects.; EFFECT=the vehicle control group and the dose groups gave no indication of test article related effects. The mean body weights of foetuses, the ratio of male and female foetuses and the results of external, visceral and skeletal examinations of foetuses gave no indication of effects caused by administration of the test article. Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I. 45100) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal organism and the NOEL (no observed effect level) for the foetal organism. Ref.: 8 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Guideline : OECD 428 (1995) Test system : split thickness pig skin (400 µm), 6 samples Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : Acid Red 52, 5 mg/ml in saline pH 3.0 Exp. II : Hair Colour Gel CI L 366I, containing 0.5% Acid Red 52 (pH 2.9 - 3.1) Control : caffeine, tested every 3 months, results available; CITATION=Ref.: 8 2; CITATION_NUMBERS=[8,2]; REFERENCE=Ref.: 8 2; DETAILS_JSON={"cas_number":"3520-42-1","citation":"Ref.: 8 2","dose":"the vehicle control group and the dose groups gave no indication of test article related effects.","duration":"3 months","effect":"the vehicle control group and the dose groups gave no indication of test article related effects. The mean body weights of foetuses, the ratio of male and female foetuses and the results of external, visceral and skeletal examinations of foetuses gave no indication of effects caused by administration of the test article. Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I. 45100) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal organism and the NOEL (no observed effect level) for the foetal organism. Ref.: 8 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous absorption Guideline : OECD 428 (1995) Test system : split thickness pig skin (400 µm), 6 samples Contact time : 30 minutes under occlusion (donor chamber covered with parafilm) Test substance : Exp. I : Acid Red 52, 5 mg/ml in saline pH 3.0 Exp. II : Hair Colour Gel CI L 366I, containing 0.5% Acid Red 52 (pH 2.9 - 3.1) Control : caffeine, tested every 3 months, results available","endpoint":"dermal absorption","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":11,"route":"","species":"pig","study_id":"out266_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | irritation | 1000 | mg/kg bw/day | - | oral | 13 weeks | irritation | SOURCE_SUBDIR=out266_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52 COLIPA n° C177; OPINION_NUMBER=SCCNFP/0803/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1000; DOSE=Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks.; EFFECT=SCCNFP/0803/04 Evaluation and opinion on Acid Red 52 _____________________________________________________________________________________________ 16 Margin of Safety NOAEL / SED = 2857 2.12. Conclusions Physico-chemical properties The information provided on the compound is incomplete. Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Skin/eye irritation and sensitisation The skin and eye irritation study are old (1976) and performed on a substance of which the exact purity is unknown. Although this study is scientifically not valid, it seems unnecessary to perform additional animal studies, especial; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3520-42-1","citation":"","dose":"Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks.","duration":"13 weeks","effect":"SCCNFP/0803/04 Evaluation and opinion on Acid Red 52 _____________________________________________________________________________________________ 16 Margin of Safety NOAEL / SED = 2857 2.12. Conclusions Physico-chemical properties The information provided on the compound is incomplete. Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Skin/eye irritation and sensitisation The skin and eye irritation study are old (1976) and performed on a substance of which the exact purity is unknown. Although this study is scientifically not valid, it seems unnecessary to perform additional animal studies, especial","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":16,"route":"oral","species":"","study_id":"out266_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 1000 | mg/kg bw/day | rabbit | oral | 13 weeks | repeated dose toxicity | SOURCE_SUBDIR=out266_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52 COLIPA n° C177; OPINION_NUMBER=SCCNFP/0803/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=1000; DOSE=tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are c...; EFFECT=tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Albino-Himalaya rabbits Group size : 6 animals; CITATION=Ref.: 6 2; CITATION_NUMBERS=[6,2]; REFERENCE=Ref.: 6 2; DETAILS_JSON={"cas_number":"3520-42-1","citation":"Ref.: 6 2","dose":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are c...","duration":"13 weeks","effect":"tine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Albino-Himalaya rabbits Group size : 6 animals","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":7,"route":"oral","species":"rabbit","study_id":"out266_en_noael_001"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg bw/day | human | - | - | - | SOURCE_SUBDIR=sccp_o_137; REPORT_TITLE=OPINION ON Acid Red 52 COLIPA n° C177; OPINION_NUMBER=SCCP/1115/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=1000; DOSE=Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I.; EFFECT=SCCP/1115/07 Opinion on Acid Red 52 20 The mean body weights of foetuses, the ratio of male and female foetuses and the results of external, visceral and skeletal examinations of foetuses gave no indication of effects caused by administration of the test article. Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I. 45100) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal organism and the NOEL (no observed effect level) for the foetal organism. Ref.: 8 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MA; CITATION=Ref.: 8 3; CITATION_NUMBERS=[8,3]; REFERENCE=Ref.: 8 3; DETAILS_JSON={"cas_number":"3520-42-1","citation":"Ref.: 8 3","dose":"Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I.","duration":"","effect":"SCCP/1115/07 Opinion on Acid Red 52 20 The mean body weights of foetuses, the ratio of male and female foetuses and the results of external, visceral and skeletal examinations of foetuses gave no indication of effects caused by administration of the test article. Conclusion Based on the results described above, 1000 mg/kg bw/day of Acid Red 52 (C.I. 45100) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal organism and the NOEL (no observed effect level) for the foetal organism. Ref.: 8 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MA","endpoint":"","ingredient":"Hydrogen-3,6-bis(diethylamino)-9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":20,"route":"","species":"human","study_id":"sccp_o_137_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.013 | mg/kg bw | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccp_o_137; REPORT_TITLE=OPINION ON Acid Red 52 COLIPA n° C177; OPINION_NUMBER=SCCP/1115/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT== 0.013; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3520-42-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"13-week","effect":"genicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","endpoint":"dermal absorption","ingredient":"Hydrogen-3,6-bis(diethylamino)-9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.013","page":20,"route":"oral","species":"rat","study_id":"sccp_o_137_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =1000 | mg/kg bw | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccp_o_137; REPORT_TITLE=OPINION ON Acid Red 52 COLIPA n° C177; OPINION_NUMBER=SCCP/1115/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT== 1000; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3520-42-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"13-week","effect":"11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","endpoint":"dermal absorption","ingredient":"Hydrogen-3,6-bis(diethylamino)-9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 1000","page":20,"route":"oral","species":"rat","study_id":"sccp_o_137_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =1000 | mg/kg bw | rat | oral | 13-week | dermal absorption | SOURCE_SUBDIR=sccp_o_137; REPORT_TITLE=OPINION ON Acid Red 52 COLIPA n° C177; OPINION_NUMBER=SCCP/1115/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT== 1000; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=ions No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3520-42-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"13-week","effect":"ions No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Red 52) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.11 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.777 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.013 mg/kg bw No observed adverse effect level NOAEL = 1000 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 76923","endpoint":"dermal absorption","ingredient":"Hydrogen-3,6-bis(diethylamino)-9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 1000","page":20,"route":"oral","species":"rat","study_id":"sccp_o_137_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 1000 | mg/kg bw/day | - | oral | 13 weeks | genotoxicity | SOURCE_SUBDIR=sccp_o_137; REPORT_TITLE=OPINION ON Acid Red 52 COLIPA n° C177; OPINION_NUMBER=SCCP/1115/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=1000; DOSE=he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological...; EFFECT=he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0803/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA 98, TA 100); E. coli (WP2uvrA) Test item: Acid Red 52 (CI 45100) Batch: 18882 Purity: ≥ 99% (HPLC, peak area); CITATION=Ref.: 6 3; CITATION_NUMBERS=[6,3]; REFERENCE=Ref.: 6 3; DETAILS_JSON={"cas_number":"3520-42-1","citation":"Ref.: 6 3","dose":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological...","duration":"13 weeks","effect":"he stomach and /or intestine, decreased uric acid levels in both sexes, decreased fibrinogen levels, increased ß-globulin levels in males, decreased billirubin and increased phospholipid levels in females (none of the clinical biochemical aberrations correlated to any histological findings, wherefore they were regarded to be of no toxicological significance; they are considered to be metabolic adaptations to the test article) Conclusion Based on the results described above, the No-Observable-Adverse-Effect-Level (NOAEL) of Acid Red 52 (CI 45100) is considered to be 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/0803/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA 98, TA 100); E. coli (WP2uvrA) Test item: Acid Red 52 (CI 45100) Batch: 18882 Purity: ≥ 99% (HPLC, peak area)","endpoint":"genotoxicity","ingredient":"Hydrogen-3,6-bis(diethylamino)-9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":16,"route":"oral","species":"","study_id":"sccp_o_137_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 1000 | mg/kg bw/day | - | oral | 13 weeks | irritation | SOURCE_SUBDIR=sccp_o_137; REPORT_TITLE=OPINION ON Acid Red 52 COLIPA n° C177; OPINION_NUMBER=SCCP/1115/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=1000; DOSE=The stability of Acid Red 52 in the marketed products is not known Acid Red 52 is also used as cosmetic colorant according to Annex VI of the Cosmetic Directive, but the present evaluation concerns only to the use of Acid Red 52 in oxidative hair dye formulations Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when admi...; EFFECT=nt of Acid Red 52 in the test materials used in various studies is not reported. Documentation for the chemical characterisation is provided only of one batch (18882). Water solubility of Acid Red 52 has not been determined by the EU Method. The stability of Acid Red 52 in the marketed products is not known Acid Red 52 is also used as cosmetic colorant according to Annex VI of the Cosmetic Directive, but the present evaluation concerns only to the use of Acid Red 52 in oxidative hair dye formulations Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Skin/eye irritation and sensitisation The skin and eye irritation study are old (1976) and performed on a substance of which the exact purity is unknown. Although this study is scientifically not valid, it seems unnecessary to perform additional animal studies, especially viewing the low percentage of the compound in its final formulation (0.6%). Acid Red 52 is regarded as non-sensitising. Percutaneous a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3520-42-1","citation":"","dose":"The stability of Acid Red 52 in the marketed products is not known Acid Red 52 is also used as cosmetic colorant according to Annex VI of the Cosmetic Directive, but the present evaluation concerns only to the use of Acid Red 52 in oxidative hair dye formulations Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when admi...","duration":"13 weeks","effect":"nt of Acid Red 52 in the test materials used in various studies is not reported. Documentation for the chemical characterisation is provided only of one batch (18882). Water solubility of Acid Red 52 has not been determined by the EU Method. The stability of Acid Red 52 in the marketed products is not known Acid Red 52 is also used as cosmetic colorant according to Annex VI of the Cosmetic Directive, but the present evaluation concerns only to the use of Acid Red 52 in oxidative hair dye formulations Toxicity The NOAEL of Acid Red 52 (CI 45100) was set at 1000 mg/kg bw/day when administered by gavage over a period of 13 weeks. Skin/eye irritation and sensitisation The skin and eye irritation study are old (1976) and performed on a substance of which the exact purity is unknown. Although this study is scientifically not valid, it seems unnecessary to perform additional animal studies, especially viewing the low percentage of the compound in its final formulation (0.6%). Acid Red 52 is regarded as non-sensitising. Percutaneous a","endpoint":"irritation","ingredient":"Hydrogen-3,6-bis(diethylamino)-9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":21,"route":"oral","species":"","study_id":"sccp_o_137_noael_006"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 821LWZ3R6R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H29N2O7S2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"821LWZ3R6R"} |
| openFDA substances | FDA UNII substance identifier | 821LWZ3R6R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H29N2O7S2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"821LWZ3R6R"} |
| openFDA substances | FDA UNII substance identifier | 821LWZ3R6R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H29N2O7S2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"821LWZ3R6R"} |
| openFDA substances | FDA UNII substance identifier | 821LWZ3R6R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C27H29N2O7S2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"821LWZ3R6R"} |