NOAEL Studies
Colorant
Red 33 (CI 17200) NOAEL Studies
INCI: CI 17200
CAS: 3567-66-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS_vision_codex 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | 100 d | NOAEL study | {"citation":"Ref.: 10 B","dose":"Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation.","effect":"f this generation (at least 100 d). Body weight and parental food consumption were recorded. Parental rats and pups were observed for toxicity signs, changes in behaviour and mortality. Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation. Result With the exception of discoloration (pink or reddish) of the urine of males and females in the highest dose group (25 mg/kg bw/d) of all generations, no treatment related effects were noted. Conclusion The NOAEL of D&C Red 33 in this study is 25 mg/kg bw/d (highest dose used). Ref.: 10 B. Long term rat feeding study, exposure beginning in utero (see 3.3.7.) In this long-term feeding study, D&C Red 33 was given in the diet at dosage levels of 0.025, 0.05 or 0.2% (it is stated that this corresponded to 12, 25, and 102 mg/kg bw/d for males and 15, 31, and 129 mg/kg bw/d for females) to rats with exposure beginning in utero. For the F0 of the study, 60 rats/sex were assigned to each treatment level and also to each of two","page":12,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_001"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw/d | rat | oral | 18 months | NOAEL study | {"citation":"Ref.: 9 C","dose":"At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article.","effect":"one or more dosage levels at 18 months, a light-red colour was noted for most rats at the 0.2 % dosage level during the urinalysis. At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article. No compound-related changes were noted in macroscopic examinations. No significant changes in the body weights between the different groups were noted. There were no pathological changes in the microscopic pathologic examination. Conclusion The NOAEL of D&C Red 33 in this long-term toxicity study is 102 mg/kg bw/d (highest dose used). Ref.: 9 C. Long term feeding study in mice (see 3.3.7) Charles River CD-1 mice, two control groups and three test groups (60 males and 60 females) were used for this assay. Groups of 60 male and 60 female mice, each were fed D&C Red 33 in their diet for 24 month. The following dose levels were tested in this study: 0.1, 1.0; and 5.0 %, two control groups were included. The criteria evaluated were haematology (after 3, 6, 12 mo","page":13,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_002"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"tation anoma1ies and effects on parturition and lactation. Indices for live birth and surviva1 to weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_003"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.18 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_005"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the s","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_006"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | developmental | developmental toxicity | {"dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","effect":"oncentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisa","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_008"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | 100 d | NOAEL study | {"citation":"Ref.: 10 B","dose":"Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation.","effect":"f this generation (at least 100 d). Body weight and parental food consumption were recorded. Parental rats and pups were observed for toxicity signs, changes in behaviour and mortality. Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation. Result With the exception of discoloration (pink or reddish) of the urine of males and females in the highest dose group (25 mg/kg bw/d) of all generations, no treatment related effects were noted. Conclusion The NOAEL of D&C Red 33 in this study is 25 mg/kg bw/d (highest dose used). Ref.: 10 B. Long term rat feeding study, exposure beginning in utero (see 3.3.7.) In this long-term feeding study, D&C Red 33 was given in the diet at dosage levels of 0.025, 0.05 or 0.2% (it is stated that this corresponded to 12, 25, and 102 mg/kg bw/d for males and 15, 31, and 129 mg/kg bw/d for females) to rats with exposure beginning in utero. For the F0 of the study, 60 rats/sex were assigned to each treatment level and also to each of two","page":12,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_001"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw/d | rat | oral | 18 months | NOAEL study | {"citation":"Ref.: 9 C","dose":"At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article.","effect":"one or more dosage levels at 18 months, a light-red colour was noted for most rats at the 0.2 % dosage level during the urinalysis. At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article. No compound-related changes were noted in macroscopic examinations. No significant changes in the body weights between the different groups were noted. There were no pathological changes in the microscopic pathologic examination. Conclusion The NOAEL of D&C Red 33 in this long-term toxicity study is 102 mg/kg bw/d (highest dose used). Ref.: 9 C. Long term feeding study in mice (see 3.3.7) Charles River CD-1 mice, two control groups and three test groups (60 males and 60 females) were used for this assay. Groups of 60 male and 60 female mice, each were fed D&C Red 33 in their diet for 24 month. The following dose levels were tested in this study: 0.1, 1.0; and 5.0 %, two control groups were included. The criteria evaluated were haematology (after 3, 6, 12 mo","page":13,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_002"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"tation anoma1ies and effects on parturition and lactation. Indices for live birth and surviva1 to weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_003"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.18 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_005"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the s","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_006"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | developmental | developmental toxicity | {"dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","effect":"oncentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisa","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_008"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | 100 d | NOAEL study | {"citation":"Ref.: 10 B","dose":"Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation.","effect":"f this generation (at least 100 d). Body weight and parental food consumption were recorded. Parental rats and pups were observed for toxicity signs, changes in behaviour and mortality. Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation. Result With the exception of discoloration (pink or reddish) of the urine of males and females in the highest dose group (25 mg/kg bw/d) of all generations, no treatment related effects were noted. Conclusion The NOAEL of D&C Red 33 in this study is 25 mg/kg bw/d (highest dose used). Ref.: 10 B. Long term rat feeding study, exposure beginning in utero (see 3.3.7.) In this long-term feeding study, D&C Red 33 was given in the diet at dosage levels of 0.025, 0.05 or 0.2% (it is stated that this corresponded to 12, 25, and 102 mg/kg bw/d for males and 15, 31, and 129 mg/kg bw/d for females) to rats with exposure beginning in utero. For the F0 of the study, 60 rats/sex were assigned to each treatment level and also to each of two","page":12,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_001"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw/d | rat | oral | 18 months | NOAEL study | {"citation":"Ref.: 9 C","dose":"At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article.","effect":"one or more dosage levels at 18 months, a light-red colour was noted for most rats at the 0.2 % dosage level during the urinalysis. At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article. No compound-related changes were noted in macroscopic examinations. No significant changes in the body weights between the different groups were noted. There were no pathological changes in the microscopic pathologic examination. Conclusion The NOAEL of D&C Red 33 in this long-term toxicity study is 102 mg/kg bw/d (highest dose used). Ref.: 9 C. Long term feeding study in mice (see 3.3.7) Charles River CD-1 mice, two control groups and three test groups (60 males and 60 females) were used for this assay. Groups of 60 male and 60 female mice, each were fed D&C Red 33 in their diet for 24 month. The following dose levels were tested in this study: 0.1, 1.0; and 5.0 %, two control groups were included. The criteria evaluated were haematology (after 3, 6, 12 mo","page":13,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_002"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"tation anoma1ies and effects on parturition and lactation. Indices for live birth and surviva1 to weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_003"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.18 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_005"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the s","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_006"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | developmental | developmental toxicity | {"dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","effect":"oncentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisa","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_008"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | 100 d | NOAEL study | {"citation":"Ref.: 10 B","dose":"Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation.","effect":"f this generation (at least 100 d). Body weight and parental food consumption were recorded. Parental rats and pups were observed for toxicity signs, changes in behaviour and mortality. Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation. Result With the exception of discoloration (pink or reddish) of the urine of males and females in the highest dose group (25 mg/kg bw/d) of all generations, no treatment related effects were noted. Conclusion The NOAEL of D&C Red 33 in this study is 25 mg/kg bw/d (highest dose used). Ref.: 10 B. Long term rat feeding study, exposure beginning in utero (see 3.3.7.) In this long-term feeding study, D&C Red 33 was given in the diet at dosage levels of 0.025, 0.05 or 0.2% (it is stated that this corresponded to 12, 25, and 102 mg/kg bw/d for males and 15, 31, and 129 mg/kg bw/d for females) to rats with exposure beginning in utero. For the F0 of the study, 60 rats/sex were assigned to each treatment level and also to each of two","page":12,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_001"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw/d | rat | oral | 18 months | NOAEL study | {"citation":"Ref.: 9 C","dose":"At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article.","effect":"one or more dosage levels at 18 months, a light-red colour was noted for most rats at the 0.2 % dosage level during the urinalysis. At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article. No compound-related changes were noted in macroscopic examinations. No significant changes in the body weights between the different groups were noted. There were no pathological changes in the microscopic pathologic examination. Conclusion The NOAEL of D&C Red 33 in this long-term toxicity study is 102 mg/kg bw/d (highest dose used). Ref.: 9 C. Long term feeding study in mice (see 3.3.7) Charles River CD-1 mice, two control groups and three test groups (60 males and 60 females) were used for this assay. Groups of 60 male and 60 female mice, each were fed D&C Red 33 in their diet for 24 month. The following dose levels were tested in this study: 0.1, 1.0; and 5.0 %, two control groups were included. The criteria evaluated were haematology (after 3, 6, 12 mo","page":13,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_002"} |
| SCCS_vision_codex | NOAEL | =102 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"tation anoma1ies and effects on parturition and lactation. Indices for live birth and surviva1 to weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_003"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","effect":"weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","page":20,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.18 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_005"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the s","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_006"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | developmental | developmental toxicity | {"dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","effect":"oncentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisa","page":21,"pdf":"sccp_o_120.pdf","row_type":"noael_study","study_id":"sccp_o_120_noael_008"} |
ToxValDB_ECHA_IUCLID 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | =181 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3c81; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/8?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15820445:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7f300af252beb39b6046bb09d61b69b7 |
| ToxValDB_ECHA_IUCLID | LOAEL | =750 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae2ae4b0a7c65d1c7c51; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/6/2?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15848931:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_abc17eef26af8031575d624da098a719 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1500 | mg/kg bw/day | Mouse | dermal | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c823e4b0a7c65d216dbc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/8?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15817676:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_edb5bdd08dfd1cf84dd9ab6746a851dd |
| ToxValDB_ECHA_IUCLID | NOAEL | =129 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3c7f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/8?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15820443:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_fa6d2c1051fe3f9eacca668107db976a |
| ToxValDB_ECHA_IUCLID | NOAEL | =102 | mg/kg bw/day | Rat | oral | - | chronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3c7f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/8?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15820444:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c1228f06568b39c2bda2371a3c9193cc |
| ToxValDB_ECHA_IUCLID | NOAEL | =150 | mg/kg bw/day | Mouse | oral | - | chronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3c81; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/8?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15820446:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_0d88c8627bea34457680d15e41309f21 |
| ToxValDB_ECHA_IUCLID | NOAEL | =25 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bd960; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/9/3?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15821525:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e69f75d24a38f90a12f59d0a9acf21ed |
| ToxValDB_ECHA_IUCLID | NOAEL | =20 | mg/kg bw/day | Rabbit | dermal | short-term; 4 weeks | short-term | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61d4be4b096bca877542d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/6/4?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15826131:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7cf09c45bf967f877ec4d4154867450c |
| ToxValDB_ECHA_IUCLID | NOAEL | =2500 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae2ae4b0a7c65d1c7c46; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/6/2?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECHA IUCLID:15849420:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_f4038a4dbb0083f5c92a3215b39e803d |
| ToxValDB_ECHA_IUCLID | NOAEL | =100 | mg/kg bw/day | Rat | oral | subchronic; 6 weeks | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae2ae4b0a7c65d1c7c63; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17285/7/6/2?documentUUID=040ee780-aff4-454e-862c-ec8bfce09ecf; YEAR=2005; ORIGINAL_YEAR=2005; STUDY_GROUP=ECHA IUCLID:15849424:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_5deaff2f37bc6b68cd56152b8e8f8b93 |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 11 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 25 | mg/kg bw/d | rat | oral | 100 d | - | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=25; DOSE=Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation.; EFFECT=f this generation (at least 100 d). Body weight and parental food consumption were recorded. Parental rats and pups were observed for toxicity signs, changes in behaviour and mortality. Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation. Result With the exception of discoloration (pink or reddish) of the urine of males and females in the highest dose group (25 mg/kg bw/d) of all generations, no treatment related effects were noted. Conclusion The NOAEL of D&C Red 33 in this study is 25 mg/kg bw/d (highest dose used). Ref.: 10 B. Long term rat feeding study, exposure beginning in utero (see 3.3.7.) In this long-term feeding study, D&C Red 33 was given in the diet at dosage levels of 0.025, 0.05 or 0.2% (it is stated that this corresponded to 12, 25, and 102 mg/kg bw/d for males and 15, 31, and 129 mg/kg bw/d for females) to rats with exposure beginning in utero. For the F0 of the study, 60 rats/sex were assigned to each treatment level and also to each of two; CITATION=Ref.: 10 B; CITATION_NUMBERS=[10]; REFERENCE=Ref.: 10 B; DETAILS_JSON={"cas_number":"3567-66-6","citation":"Ref.: 10 B","dose":"Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation.","duration":"100 d","effect":"f this generation (at least 100 d). Body weight and parental food consumption were recorded. Parental rats and pups were observed for toxicity signs, changes in behaviour and mortality. Histopathology (14 representative tissues) was performed from control and high dose group from F1 and F3a generation. Result With the exception of discoloration (pink or reddish) of the urine of males and females in the highest dose group (25 mg/kg bw/d) of all generations, no treatment related effects were noted. Conclusion The NOAEL of D&C Red 33 in this study is 25 mg/kg bw/d (highest dose used). Ref.: 10 B. Long term rat feeding study, exposure beginning in utero (see 3.3.7.) In this long-term feeding study, D&C Red 33 was given in the diet at dosage levels of 0.025, 0.05 or 0.2% (it is stated that this corresponded to 12, 25, and 102 mg/kg bw/d for males and 15, 31, and 129 mg/kg bw/d for females) to rats with exposure beginning in utero. For the F0 of the study, 60 rats/sex were assigned to each treatment level and also to each of two","endpoint":"","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":12,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 102 | mg/kg bw/d | rat | oral | 18 months | - | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=102; DOSE=At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article.; EFFECT=one or more dosage levels at 18 months, a light-red colour was noted for most rats at the 0.2 % dosage level during the urinalysis. At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article. No compound-related changes were noted in macroscopic examinations. No significant changes in the body weights between the different groups were noted. There were no pathological changes in the microscopic pathologic examination. Conclusion The NOAEL of D&C Red 33 in this long-term toxicity study is 102 mg/kg bw/d (highest dose used). Ref.: 9 C. Long term feeding study in mice (see 3.3.7) Charles River CD-1 mice, two control groups and three test groups (60 males and 60 females) were used for this assay. Groups of 60 male and 60 female mice, each were fed D&C Red 33 in their diet for 24 month. The following dose levels were tested in this study: 0.1, 1.0; and 5.0 %, two control groups were included. The criteria evaluated were haematology (after 3, 6, 12 mo; CITATION=Ref.: 9 C; CITATION_NUMBERS=[9]; REFERENCE=Ref.: 9 C; DETAILS_JSON={"cas_number":"3567-66-6","citation":"Ref.: 9 C","dose":"At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article.","duration":"18 months","effect":"one or more dosage levels at 18 months, a light-red colour was noted for most rats at the 0.2 % dosage level during the urinalysis. At 24 months, other than colour, no differences were noted between the control and treated rats that could be attributed to the test article. No compound-related changes were noted in macroscopic examinations. No significant changes in the body weights between the different groups were noted. There were no pathological changes in the microscopic pathologic examination. Conclusion The NOAEL of D&C Red 33 in this long-term toxicity study is 102 mg/kg bw/d (highest dose used). Ref.: 9 C. Long term feeding study in mice (see 3.3.7) Charles River CD-1 mice, two control groups and three test groups (60 males and 60 females) were used for this assay. Groups of 60 male and 60 female mice, each were fed D&C Red 33 in their diet for 24 month. The following dose levels were tested in this study: 0.1, 1.0; and 5.0 %, two control groups were included. The criteria evaluated were haematology (after 3, 6, 12 mo","endpoint":"","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"102","page":13,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.18 | mg/kg | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 0.18; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...; EFFECT=SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3567-66-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","duration":"","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for","endpoint":"dermal absorption","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.18","page":21,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =25 | mg/kg | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 25; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...; EFFECT=SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3567-66-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","duration":"","effect":"SCCP/1102/07 Opinion on Acid Red 33 21 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the s","endpoint":"dermal absorption","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg","noael_value":"= 25","page":21,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =25 | mg/kg | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT== 25; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...; EFFECT=3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3567-66-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg...","duration":"","effect":"3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (4-Hydroxypropylamino-3-nitrophenol) (Direct / semi-permanent) Maximum absorption through the skin A (µg/cm2) = 15.2 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 10.64 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.18 mg/kg No observed adverse effect level NOAEL = 25 mg/kg (multi-generation, oral, rat) Margin of Safety NOAEL / SED = 139 3.3.14. Discussion Physico-chemical properties Acid Red 33 is used as a non-reactive dye up to an on-head concentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'","endpoint":"dermal absorption","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg","noael_value":"= 25","page":21,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 0 | mg/kg bw | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=000; DOSE=Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.; EFFECT=oncentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisa; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3567-66-6","citation":"","dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","duration":"developmental","effect":"oncentration of 0.5% in non- oxidative hair dye formulation. The overall purity (NMR) of the test item is greater than 82% and the solvent content plus other impurities is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisa","endpoint":"developmental toxicity","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw","noael_value":"000","page":21,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 25 | mg/kg bw/d | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=25; DOSE=Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.; EFFECT=s is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisation test. Dermal absorption As too few test chambers were used in the percutaneous absorption study on pig skin in vitro, the Amax of 15.2 µg/cm² is used for calcul; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3567-66-6","citation":"","dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","duration":"developmental","effect":"s is less than 10%. Therefore, about 8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisation test. Dermal absorption As too few test chambers were used in the percutaneous absorption study on pig skin in vitro, the Amax of 15.2 µg/cm² is used for calcul","endpoint":"developmental toxicity","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":21,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 25 | mg/kg bw/d | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=25; DOSE=Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.; EFFECT=8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisation test. Dermal absorption As too few test chambers were used in the percutaneous absorption study on pig skin in vitro, the Amax of 15.2 µg/cm² is used for calculating the MOS. Mutagenicity / geno; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3567-66-6","citation":"","dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","duration":"developmental","effect":"8% of the test item is unknown. No data were provided for most physical and chemical constants. No data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisation test. Dermal absorption As too few test chambers were used in the percutaneous absorption study on pig skin in vitro, the Amax of 15.2 µg/cm² is used for calculating the MOS. Mutagenicity / geno","endpoint":"developmental toxicity","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"25","page":21,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 129 | mg/kg bw | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=129; DOSE=Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.; EFFECT=o data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisation test. Dermal absorption As too few test chambers were used in the percutaneous absorption study on pig skin in vitro, the Amax of 15.2 µg/cm² is used for calculating the MOS. Mutagenicity / genotoxicity Overall, the genotoxicity program on Acid Red 33 investigated the three types of mutation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3567-66-6","citation":"","dose":"Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs.","duration":"developmental","effect":"o data were provided for the stability in marketed products. Acid Red 33 contains several 'CMR'-impurities General toxicity The acute oral toxicity (LD50) was > 3 160 mg/kg bw in rats and > 1 000 mg/kg bw in dogs. The NOAEL in a long-term feeding toxicity study in rats was set at 102 mg/kg bw/d. In mice, the LOEL was set at 150 mg/kg bw/day. In a multi-generation study in rats, the NOAEL was set at 25 mg/kg bw/d. The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Irritation / sensitisation Acid Red 33 was considered not to be irritant to rabbit skin and eye. It was found not to be a skin sensitiser in a Guinea pig maximisation test. Dermal absorption As too few test chambers were used in the percutaneous absorption study on pig skin in vitro, the Amax of 15.2 µg/cm² is used for calculating the MOS. Mutagenicity / genotoxicity Overall, the genotoxicity program on Acid Red 33 investigated the three types of mutation","endpoint":"developmental toxicity","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw","noael_value":"129","page":21,"route":"oral","species":"rat","study_id":"sccp_o_120_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 102 | mg/kg bw | rat | - | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=102; DOSE=Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.; EFFECT=tation anoma1ies and effects on parturition and lactation. Indices for live birth and surviva1 to weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref.: 9 3; CITATION_NUMBERS=[9,3]; REFERENCE=Ref.: 9 3; DETAILS_JSON={"cas_number":"3567-66-6","citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","duration":"developmental","effect":"tation anoma1ies and effects on parturition and lactation. Indices for live birth and surviva1 to weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"reproductive toxicity","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw","noael_value":"102","page":20,"route":"","species":"rat","study_id":"sccp_o_120_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 129 | mg/kg bw | rat | - | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_120; REPORT_TITLE=OPINION ON Acid Red 33 COLIPA n° C22; OPINION_NUMBER=SCCP/1102/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=129; DOSE=Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.; EFFECT=weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref.: 9 3; CITATION_NUMBERS=[9,3]; REFERENCE=Ref.: 9 3; DETAILS_JSON={"cas_number":"3567-66-6","citation":"Ref.: 9 3","dose":"Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females.","duration":"developmental","effect":"weaning were ca1cu1ated. Throughout the in utero and post weaning segments of the study, rats were observed daily for signs of overt toxicity, morbidity and morta1ity. Detailed physica1 examinations were recorded week1y. Results No effects attributable to the test compound were seen in survival, body weights, food consumption, ophthalmoscopic examinations, fertility or gestation and lactation indices. Conclusion The NOAEL of parental toxicity was set at 102 mg/kg bw for males and at 129 mg/kg bw for females. The NOAEL for developmental toxicity was set at 129 mg/kg bw/d. Ref.: 9 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"reproductive toxicity","ingredient":"5-Amino-4-hydroxy-3-phenylazo-2,7","loael_value":"","noael_unit":"mg/kg bw","noael_value":"129","page":20,"route":"","species":"rat","study_id":"sccp_o_120_noael_004"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 9DBA0SBB0L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H11N3O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9DBA0SBB0L"} |
| openFDA substances | FDA UNII substance identifier | 9DBA0SBB0L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H11N3O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9DBA0SBB0L"} |
| openFDA substances | FDA UNII substance identifier | 9DBA0SBB0L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H11N3O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9DBA0SBB0L"} |
| openFDA substances | FDA UNII substance identifier | 9DBA0SBB0L | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C16H11N3O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9DBA0SBB0L"} |