NOAEL Studies
Cosmetic Ingredient
CI 10316 (Ext. D&C Yellow No. 7) NOAEL Studies
INCI: CI 10316
CAS: 846-70-8
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 | 30 | mg/kg bw/day | rat | oral | 90 day | Subchronic | PAFA; Damme, B.et al. 13-Week Oral (Gavage) ToxicityStudy in the Wistar Rat; RCC |
SCCNFP_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"e at 300 mg/kg bw/day.","effect":"e at 300 mg/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data","page":8,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | pig | - | developmental | developmental toxicity | {"citation":"Ref.: 7 2","dose":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 7 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous Absorption in vitro Guideline : / Tissue : Ear pig skin obtained by dissection Method : Flow-through Franz diffusion cells Test substance 1 : Acid Yellow 1 dissolved in saline at pH 3.0 (5 mg/ ml) Test substance 2 : Representative hair dye formulation (pH 3.0) containing 0.5% Acid Yellow 1 Batch No : AG 6738","page":12,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | guinea pig | - | 18 month | developmental toxicity | {"citation":"Ref.: 12 Human studies No data 2","dose":"Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.","effect":"d 6 cm2 area. Survival, body weight, and palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but n","page":16,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"e at 300 mg/kg bw/day.","effect":"e at 300 mg/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data","page":8,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | pig | - | developmental | developmental toxicity | {"citation":"Ref.: 7 2","dose":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 7 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous Absorption in vitro Guideline : / Tissue : Ear pig skin obtained by dissection Method : Flow-through Franz diffusion cells Test substance 1 : Acid Yellow 1 dissolved in saline at pH 3.0 (5 mg/ ml) Test substance 2 : Representative hair dye formulation (pH 3.0) containing 0.5% Acid Yellow 1 Batch No : AG 6738","page":12,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | guinea pig | - | 18 month | developmental toxicity | {"citation":"Ref.: 12 Human studies No data 2","dose":"Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.","effect":"d 6 cm2 area. Survival, body weight, and palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but n","page":16,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"e at 300 mg/kg bw/day.","effect":"e at 300 mg/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data","page":8,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | pig | - | developmental | developmental toxicity | {"citation":"Ref.: 7 2","dose":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 7 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous Absorption in vitro Guideline : / Tissue : Ear pig skin obtained by dissection Method : Flow-through Franz diffusion cells Test substance 1 : Acid Yellow 1 dissolved in saline at pH 3.0 (5 mg/ ml) Test substance 2 : Representative hair dye formulation (pH 3.0) containing 0.5% Acid Yellow 1 Batch No : AG 6738","page":12,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | guinea pig | - | 18 month | developmental toxicity | {"citation":"Ref.: 12 Human studies No data 2","dose":"Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.","effect":"d 6 cm2 area. Survival, body weight, and palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but n","page":16,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =30 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 3 2","dose":"e at 300 mg/kg bw/day.","effect":"e at 300 mg/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data","page":8,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =50 | mg/kg bw/day | pig | - | developmental | developmental toxicity | {"citation":"Ref.: 7 2","dose":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 7 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous Absorption in vitro Guideline : / Tissue : Ear pig skin obtained by dissection Method : Flow-through Franz diffusion cells Test substance 1 : Acid Yellow 1 dissolved in saline at pH 3.0 (5 mg/ ml) Test substance 2 : Representative hair dye formulation (pH 3.0) containing 0.5% Acid Yellow 1 Batch No : AG 6738","page":12,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =0 | mg/kg bw/day | guinea pig | - | 18 month | developmental toxicity | {"citation":"Ref.: 12 Human studies No data 2","dose":"Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.","effect":"d 6 cm2 area. Survival, body weight, and palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but n","page":16,"pdf":"out256_en.pdf","row_type":"noael_study","study_id":"out256_en_noael_004"} |
SCCS_vision_codex 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.","effect":"/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected.","page":17,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 23 3","dose":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 23 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_004"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the v","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0009 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700...","effect":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_007"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.","effect":"/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected.","page":17,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 23 3","dose":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 23 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_004"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the v","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0009 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700...","effect":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_007"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.","effect":"/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected.","page":17,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 23 3","dose":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 23 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_004"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the v","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0009 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700...","effect":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_007"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 16 3","dose":"In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.","effect":"/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected.","page":17,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_001"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | human | - | developmental | developmental toxicity | {"citation":"Ref.: 23 3","dose":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","effect":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 23 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":22,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_004"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the v","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.0009 | mg/kg bw | rat | oral | 90-day | dermal absorption | {"dose":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700...","effect":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on","page":23,"pdf":"sccp_o_155.pdf","row_type":"noael_study","study_id":"sccp_o_155_noael_007"} |
UnifiedCodex:SCCNFP:beta.noael_studies 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 50 | mg/kg bw/day | pig | - | developmental | developmental toxicity | SOURCE_SUBDIR=out256_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 1 COLIPA n° B1; OPINION_NUMBER=SCCNFP/0783/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.; EFFECT=0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 7 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous Absorption in vitro Guideline : / Tissue : Ear pig skin obtained by dissection Method : Flow-through Franz diffusion cells Test substance 1 : Acid Yellow 1 dissolved in saline at pH 3.0 (5 mg/ ml) Test substance 2 : Representative hair dye formulation (pH 3.0) containing 0.5% Acid Yellow 1 Batch No : AG 6738; CITATION=Ref.: 7 2; CITATION_NUMBERS=[7,2]; REFERENCE=Ref.: 7 2; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 7 2","dose":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","duration":"developmental","effect":"0 mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 7 2.7. Toxicokinetics (incl. Percutaneous Absorption) Percutaneous Absorption in vitro Guideline : / Tissue : Ear pig skin obtained by dissection Method : Flow-through Franz diffusion cells Test substance 1 : Acid Yellow 1 dissolved in saline at pH 3.0 (5 mg/ ml) Test substance 2 : Representative hair dye formulation (pH 3.0) containing 0.5% Acid Yellow 1 Batch No : AG 6738","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":12,"route":"","species":"pig","study_id":"out256_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 0 | mg/kg bw/day | guinea pig | - | 18 month | developmental toxicity | SOURCE_SUBDIR=out256_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 1 COLIPA n° B1; OPINION_NUMBER=SCCNFP/0783/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=0; DOSE=Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.; EFFECT=d 6 cm2 area. Survival, body weight, and palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but n; CITATION=Ref.: 12 Human studies No data 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref.: 12 Human studies No data 2; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 12 Human studies No data 2","dose":"Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.","duration":"18 month","effect":"d 6 cm2 area. Survival, body weight, and palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but n","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"0","page":16,"route":"","species":"guinea pig","study_id":"out256_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 50 | mg/kg bw/day | guinea pig | - | 18 month | developmental toxicity | SOURCE_SUBDIR=out256_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 1 COLIPA n° B1; OPINION_NUMBER=SCCNFP/0783/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=50; DOSE=Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.; EFFECT=palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but not in the local lymph node assay. The p; CITATION=Ref.: 12 Human studies No data 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref.: 12 Human studies No data 2; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 12 Human studies No data 2","dose":"Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs.","duration":"18 month","effect":"palpable growth were followed for a 18 month period. Microscopic examination which initially involved 50% of the treated animals was extended to include all tumours and grossly abnormal tissues and organs. There was no significant difference between treatment and control groups. Ref.: 12 Human studies No data 2.10. Special investigations No data 2.11. Safety evaluation Not applicable 2.12. Conclusions The chemical characterisation of Acid Yellow 1 is incomplete. A NOAEL of 30 mg/kg bw/day was derived. A NOAEL for maternal toxicity of 50 mg/kg bw/day, and for foetal toxicity of 150 mg/kg bw/day were set. There was no indication of teratogenic potential. The data on irritation is incomplete. No data were provided for skin irritation. The assessment of eye irritation potential was based solely on the NRU-50, which is currently not validated. The sensitization potential is equivocal. Acid Yellow 1 showed a sensitising potential in the skin sensitisation test with guinea pigs, but not in the local lymph node assay. The p","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":16,"route":"","species":"guinea pig","study_id":"out256_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 30 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out256_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 1 COLIPA n° B1; OPINION_NUMBER=SCCNFP/0783/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=30; DOSE=e at 300 mg/kg bw/day.; EFFECT=e at 300 mg/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data; CITATION=Ref.: 3 2; CITATION_NUMBERS=[3,2]; REFERENCE=Ref.: 3 2; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 3 2","dose":"e at 300 mg/kg bw/day.","duration":"Sub-chronic","effect":"e at 300 mg/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":8,"route":"dermal","species":"","study_id":"out256_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 30 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out256_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID YELLOW 1 COLIPA n° B1; OPINION_NUMBER=SCCNFP/0783/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=30; DOSE=In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.; EFFECT=rophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data; CITATION=Ref.: 3 2; CITATION_NUMBERS=[3,2]; REFERENCE=Ref.: 3 2; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 3 2","dose":"In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.","duration":"Sub-chronic","effect":"rophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 3 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) No data","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":8,"route":"dermal","species":"","study_id":"out256_en_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0011 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT== 0.0011; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"90-day","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using","endpoint":"dermal absorption","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0011","page":23,"route":"oral","species":"rat","study_id":"sccp_o_155_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the v; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"90-day","effect":"SCCP/1160/08 Opinion on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the v","endpoint":"dermal absorption","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 30","page":23,"route":"oral","species":"rat","study_id":"sccp_o_155_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT== 30; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=on on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had se; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"90-day","effect":"on on Acid Yellow 1 23 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (Acid Yellow 1) (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 0.096 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.067 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had se","endpoint":"dermal absorption","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 30","page":23,"route":"oral","species":"rat","study_id":"sccp_o_155_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.0009 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT== 0.0009; DOSE=y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700...; EFFECT=y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700...","duration":"90-day","effect":"y weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on","endpoint":"dermal absorption","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.0009","page":23,"route":"oral","species":"rat","study_id":"sccp_o_155_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT== 30; DOSE=ic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatm...; EFFECT=ic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"ic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatm...","duration":"90-day","effect":"ic exposure dose (SED) SAS x A x 0.001/60 = 0.0011 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head","endpoint":"dermal absorption","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 30","page":23,"route":"oral","species":"rat","study_id":"sccp_o_155_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg bw | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT== 30; DOSE=w No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of huma...; EFFECT=w No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. T; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"w No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of huma...","duration":"90-day","effect":"w No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 27273 (Acid Yellow 1) (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 0.078 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.055 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0009 mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (90-day, oral, rat) Margin of Safety NOAEL / SED = 33333 Comment Using the values of the in vitro dermal absorption study which had several shortcomings, a very high Margin of Safety is calculated. In this case, the dermal absorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. T","endpoint":"dermal absorption","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 30","page":23,"route":"oral","species":"rat","study_id":"sccp_o_155_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 50 | mg/kg bw/day | human | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT=50; DOSE=mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.; EFFECT=mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 23 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref.: 23 3; CITATION_NUMBERS=[23,3]; REFERENCE=Ref.: 23 3; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 23 3","dose":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group.","duration":"developmental","effect":"mg/kg bw/day, mean foetal body weights were significantly reduced (17 %) compared with the control group. There were minor skeletal variations consisting of incomplete ossification of sternebrae, metatarsal -1, talus and phalanges. This incomplete ossification was associated with the overall reduced development as a result of maternal toxicity. The study authors considered it was a minor developmental delay. Conclusion On the basis of these results, the study authors derived a no observable adverse effect level (NOAEL) for maternal toxicity at 50 mg/kg bw/day and for foetuses 150 mg/kg bw/day. There was no indication of teratogenic potential. Ref.: 23 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"developmental toxicity","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":22,"route":"","species":"human","study_id":"sccp_o_155_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 30 | mg/kg bw/day | human | - | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT=30; DOSE=General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL).; EFFECT=sorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. The stability of Acid Yellow 1 in marketed products is not reported. General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). The No Observable Adverse Effect Level (NOAEL) for maternal toxicity was set at 50 mg/kg bw/day and at 150 mg/kg bw/day for foeto-toxicity. There was no indication of teratogenic potential. Irritation / sensitisation Acid Yellow 1 is considered to be non-irritant to human skin (% MTT viability > 50%), when tested neat and at 2% in water, based on the percent viability measured in the MTT assay.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL).","duration":"90-day","effect":"sorption study can be exceptionally accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. The stability of Acid Yellow 1 in marketed products is not reported. General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). The No Observable Adverse Effect Level (NOAEL) for maternal toxicity was set at 50 mg/kg bw/day and at 150 mg/kg bw/day for foeto-toxicity. There was no indication of teratogenic potential. Irritation / sensitisation Acid Yellow 1 is considered to be non-irritant to human skin (% MTT viability > 50%), when tested neat and at 2% in water, based on the percent viability measured in the MTT assay.","endpoint":"developmental toxicity","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":23,"route":"","species":"human","study_id":"sccp_o_155_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 30 | mg/kg bw/day | human | - | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT=30; DOSE=General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL).; EFFECT=y accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. The stability of Acid Yellow 1 in marketed products is not reported. General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). The No Observable Adverse Effect Level (NOAEL) for maternal toxicity was set at 50 mg/kg bw/day and at 150 mg/kg bw/day for foeto-toxicity. There was no indication of teratogenic potential. Irritation / sensitisation Acid Yellow 1 is considered to be non-irritant to human skin (% MTT viability > 50%), when tested neat and at 2% in water, based on the percent viability measured in the MTT assay.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL).","duration":"90-day","effect":"y accepted. 3.3.14. Discussion Physico-chemical properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. The stability of Acid Yellow 1 in marketed products is not reported. General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). The No Observable Adverse Effect Level (NOAEL) for maternal toxicity was set at 50 mg/kg bw/day and at 150 mg/kg bw/day for foeto-toxicity. There was no indication of teratogenic potential. Irritation / sensitisation Acid Yellow 1 is considered to be non-irritant to human skin (% MTT viability > 50%), when tested neat and at 2% in water, based on the percent viability measured in the MTT assay.","endpoint":"developmental toxicity","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":23,"route":"","species":"human","study_id":"sccp_o_155_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 50 | mg/kg bw/day | human | - | 90-day | developmental toxicity | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT=50; DOSE=General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL).; EFFECT=l properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. The stability of Acid Yellow 1 in marketed products is not reported. General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). The No Observable Adverse Effect Level (NOAEL) for maternal toxicity was set at 50 mg/kg bw/day and at 150 mg/kg bw/day for foeto-toxicity. There was no indication of teratogenic potential. Irritation / sensitisation Acid Yellow 1 is considered to be non-irritant to human skin (% MTT viability > 50%), when tested neat and at 2% in water, based on the percent viability measured in the MTT assay.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"846-70-8","citation":"","dose":"General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL).","duration":"90-day","effect":"l properties Acid Yellow 1 is used in oxidative hair dye formulations at a maximum on-head concentration of 1 %. It is proposed to be used in semi-permanent hair dye formulas at a maximum on-head concentration of 0.2 % in the finished cosmetic product. The stability of Acid Yellow 1 in marketed products is not reported. General toxicity Based on the results of the 90-day study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). The No Observable Adverse Effect Level (NOAEL) for maternal toxicity was set at 50 mg/kg bw/day and at 150 mg/kg bw/day for foeto-toxicity. There was no indication of teratogenic potential. Irritation / sensitisation Acid Yellow 1 is considered to be non-irritant to human skin (% MTT viability > 50%), when tested neat and at 2% in water, based on the percent viability measured in the MTT assay.","endpoint":"developmental toxicity","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":23,"route":"","species":"human","study_id":"sccp_o_155_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 30 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT=30; DOSE=In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.; EFFECT=/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected.; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 16 3","dose":"In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.","duration":"Chronic","effect":"/kg bw/day. This hypertrophy was ambiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected.","endpoint":"genotoxicity","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":17,"route":"","species":"","study_id":"sccp_o_155_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 30 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccp_o_155; REPORT_TITLE=OPINION ON Acid Yellow 1 COLIPA n° B1; OPINION_NUMBER=SCCP/1160/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 23 April 2003; VALUE_TEXT=30; DOSE=In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.; EFFECT=mbiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected. Exp. D; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"846-70-8","citation":"Ref.: 16 3","dose":"In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed.","duration":"Chronic","effect":"mbiguous, since it was followed by the statement ‘but was not accompanied by further effects, as there was Kupffer cell proliferation, increased apoptosis, necrosis, fibrosis etc’. In the kidneys of 8 females at 300 mg/kg bw/day, a moderate to severe diffuse basophilia in the corticomedullary junction, accompanied by tubular epithelial hypertrophy and by karyomegaly was observed. Conclusion Based on the results of the study, 30 mg/kg bw/day of Acid Yellow 1 was established as the no observed adverse effect level (NOAEL). Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Taken from SCCNFP/0783/04 Guideline: OECD/471 (1997) Species/Strain: S. typhimurium (TA1535, TA1537, TA98, TA100); E. coli (WP2 uvrA) Test item: Ext D&C Yellow 7 (CI 10316) Batch: 14067; Lot AG6738 Purity: certified total colour content: 89% (+volatile matter: 70%). Stored at room temperature, light and humidity protected. Exp. D","endpoint":"genotoxicity","ingredient":"Acid Yellow 1","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":17,"route":"","species":"","study_id":"sccp_o_155_noael_002"} |
openFDA substances 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 08F8S9O3I5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H4N2O8S.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08F8S9O3I5"} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | 08F8S9O3I5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H4N2O8S.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08F8S9O3I5"} |
| openFDA substances | FDA UNII substance identifier | 08F8S9O3I5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H4N2O8S.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08F8S9O3I5"} |
| openFDA substances | FDA UNII substance identifier | 08F8S9O3I5 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C10H4N2O8S.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"08F8S9O3I5"} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |