NOAEL Studies
Cosmetic Ingredient
2-Amino-4-Hydroxyethylaminoanisole NOAEL Studies
INCI: 2-AMINO-4-HYDROXYETHYLAMINOANISOLE
CAS: 83763-47-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS_vision_codex 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats","dose":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed ad...","effect":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw of 2-amino-4-hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and so was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicit","page":18,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"e spontaneous variation range for the rat strain used and were not dose-dependent.","effect":"e spontaneous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"used and were not dose-dependent.","effect":"used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.23 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"icity No data 3.3.11. Human data No data 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_005"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"ta 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_006"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats","dose":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethyla...","effect":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and consequently was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.","page":20,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"neous variation range for the rat strain used and were not dose-dependent.","effect":"neous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"re not dose-dependent.","effect":"re not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values durin","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_003"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats","dose":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed ad...","effect":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw of 2-amino-4-hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and so was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicit","page":18,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"e spontaneous variation range for the rat strain used and were not dose-dependent.","effect":"e spontaneous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"used and were not dose-dependent.","effect":"used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.23 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"icity No data 3.3.11. Human data No data 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_005"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"ta 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_006"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats","dose":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed ad...","effect":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw of 2-amino-4-hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and so was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicit","page":18,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"e spontaneous variation range for the rat strain used and were not dose-dependent.","effect":"e spontaneous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"used and were not dose-dependent.","effect":"used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.23 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"icity No data 3.3.11. Human data No data 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_005"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"ta 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_006"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats","dose":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethyla...","effect":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and consequently was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.","page":20,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"neous variation range for the rat strain used and were not dose-dependent.","effect":"neous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"re not dose-dependent.","effect":"re not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values durin","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_003"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats","dose":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethyla...","effect":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and consequently was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.","page":20,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"neous variation range for the rat strain used and were not dose-dependent.","effect":"neous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"re not dose-dependent.","effect":"re not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values durin","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_003"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats","dose":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed ad...","effect":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw of 2-amino-4-hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and so was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicit","page":18,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"e spontaneous variation range for the rat strain used and were not dose-dependent.","effect":"e spontaneous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"used and were not dose-dependent.","effect":"used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire","page":26,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_003"} |
| SCCS_vision_codex | NOAEL | =0.23 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"icity No data 3.3.11. Human data No data 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_005"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg | rat | oral | 15-week | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","effect":"ta 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","page":28,"pdf":"sccp_o_043.pdf","row_type":"noael_study","study_id":"sccp_o_043_noael_006"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats","dose":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethyla...","effect":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and consequently was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.","page":20,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"neous variation range for the rat strain used and were not dose-dependent.","effect":"neous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_002"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | - | - | NOAEL study | {"citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"re not dose-dependent.","effect":"re not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values durin","page":27,"pdf":"sccp_o_136.pdf","row_type":"noael_study","study_id":"sccp_o_136_noael_003"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 13 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 30 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=30; DOSE=e spontaneous variation range for the rat strain used and were not dose-dependent.; EFFECT=e spontaneous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain; CITATION=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; CITATION_NUMBERS=[33,2,198]; REFERENCE=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; DETAILS_JSON={"cas_number":"83763-47-7","citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"e spontaneous variation range for the rat strain used and were not dose-dependent.","duration":"","effect":"e spontaneous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain","endpoint":"","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"30","page":26,"route":"","species":"rat","study_id":"sccp_o_043_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=150; DOSE=used and were not dose-dependent.; EFFECT=used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire; CITATION=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; CITATION_NUMBERS=[33,2,198]; REFERENCE=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; DETAILS_JSON={"cas_number":"83763-47-7","citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"used and were not dose-dependent.","duration":"","effect":"used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw. Thus, a NOAEL of 30 mg/kg bw for maternal effects and a NOAEL of 150 mg/kg bw for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire","endpoint":"","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"150","page":26,"route":"","species":"rat","study_id":"sccp_o_043_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=150; DOSE=The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19.; EFFECT=e Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire treatment period, and compared to the concurrent control group, a trend towards an increased rate of skeletal variations was noted. Based on the findings noted, 150 mg/kg bw was deduced as NOAEL for both maternal toxicity and embryotoxicity. As the protocol used in this study is no longer accepted and the material used was not specified, the study is not presented here in detail.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83763-47-7","citation":"","dose":"The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19.","duration":"","effect":"e Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw, analysis was performed on GD 19. At 350 mg/kg bw, the body weight gain of dams was below mean values during the entire treatment period, and compared to the concurrent control group, a trend towards an increased rate of skeletal variations was noted. Based on the findings noted, 150 mg/kg bw was deduced as NOAEL for both maternal toxicity and embryotoxicity. As the protocol used in this study is no longer accepted and the material used was not specified, the study is not presented here in detail.","endpoint":"","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"150","page":26,"route":"","species":"rat","study_id":"sccp_o_043_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 30 | mg/kg bw/day | rat | - | - | - | SOURCE_SUBDIR=sccp_o_136; REPORT_TITLE=OPINION ON 2-Amino-4-hydroxyethylaminoanisole sulfate COLIPA n° A84; OPINION_NUMBER=SCCP/1172/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=30; DOSE=neous variation range for the rat strain used and were not dose-dependent.; EFFECT=neous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the; CITATION=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; CITATION_NUMBERS=[33,2,198]; REFERENCE=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; DETAILS_JSON={"cas_number":"83763-47-7","citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"neous variation range for the rat strain used and were not dose-dependent.","duration":"","effect":"neous variation range for the rat strain used and were not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the","endpoint":"","ingredient":"2-Amino-4-hydroxyethylaminoanisole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":27,"route":"","species":"rat","study_id":"sccp_o_136_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw/day | rat | - | - | - | SOURCE_SUBDIR=sccp_o_136; REPORT_TITLE=OPINION ON 2-Amino-4-hydroxyethylaminoanisole sulfate COLIPA n° A84; OPINION_NUMBER=SCCP/1172/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=150; DOSE=re not dose-dependent.; EFFECT=re not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values durin; CITATION=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; CITATION_NUMBERS=[33,2,198]; REFERENCE=Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198; DETAILS_JSON={"cas_number":"83763-47-7","citation":"Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 198","dose":"re not dose-dependent.","duration":"","effect":"re not dose-dependent. No statistically significant differences in any malformation were noted compared with the concurrent control. Conclusion In this rat teratogenicity study reduced food consumption and body weight gain were noted in dams of the high dose group (150 mg/kg bw/day) during GD 6 to 20, indicating maternal systemic toxicity of the test item. No treatment-related effects were noted in foetuses up to the highest test dose of 150 mg/kg bw/day. Thus, a NOAEL of 30 mg/kg bw/day for maternal effects and a NOAEL of 150 mg/kg bw/day for embryo-foetal effects were deduced for 2-amino-hydroxyethylamino-anisole sulfate. Ref.: 33 In a former dossier submission, a teratogenicity study in mated female Sprague Dawley rats was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values durin","endpoint":"","ingredient":"2-Amino-4-hydroxyethylaminoanisole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":27,"route":"","species":"rat","study_id":"sccp_o_136_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw/day | human | - | - | - | SOURCE_SUBDIR=sccp_o_136; REPORT_TITLE=OPINION ON 2-Amino-4-hydroxyethylaminoanisole sulfate COLIPA n° A84; OPINION_NUMBER=SCCP/1172/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=150; DOSE=The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19.; EFFECT=s was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values during the entire treatment period, and compared to the concurrent control group, a trend towards an increased rate of skeletal variations was noted. Based on the findings noted, 150 mg/kg bw/day was deduced as NOAEL for both maternal toxicity and embryotoxicity. As the protocol used in this study is no longer accepted and the material used was not specified, the study is not presented here in detail. 3.3.9. Toxicokinetics Taken from SCCP/0958/05 In vitro Guideline: / Cells: Human intestinal epithelial cell line TC-7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83763-47-7","citation":"","dose":"The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19.","duration":"","effect":"s was described that was performed with 2-amino-hydroxyethylamino-anisole sulfate in 1981. The test substance was orally administered from GD 6 to 15 of gestation at doses of 0, 150 and 350 mg/kg bw/day, analysis was performed on GD 19. At 350 mg/kg bw/day, the body weight gain of dams was below mean values during the entire treatment period, and compared to the concurrent control group, a trend towards an increased rate of skeletal variations was noted. Based on the findings noted, 150 mg/kg bw/day was deduced as NOAEL for both maternal toxicity and embryotoxicity. As the protocol used in this study is no longer accepted and the material used was not specified, the study is not presented here in detail. 3.3.9. Toxicokinetics Taken from SCCP/0958/05 In vitro Guideline: / Cells: Human intestinal epithelial cell line TC-7","endpoint":"","ingredient":"2-Amino-4-hydroxyethylaminoanisole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":27,"route":"","species":"human","study_id":"sccp_o_136_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.23 | mg/kg | rat | oral | 15-week | dermal absorption | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 0.23; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...; EFFECT=icity No data 3.3.11. Human data No data 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83763-47-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","duration":"15-week","effect":"icity No data 3.3.11. Human data No data 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","endpoint":"dermal absorption","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.23","page":28,"route":"oral","species":"rat","study_id":"sccp_o_043_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =15 | mg/kg | rat | oral | 15-week | dermal absorption | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 15; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...; EFFECT=ta 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83763-47-7","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.7...","duration":"15-week","effect":"ta 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","endpoint":"dermal absorption","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 15","page":28,"route":"oral","species":"rat","study_id":"sccp_o_043_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =15 | mg/kg | rat | oral | 15-week | dermal absorption | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 15; DOSE=evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Sy...; EFFECT=evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83763-47-7","citation":"","dose":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Sy...","duration":"15-week","effect":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Amino-5-hydroxyethylaminoanisole sulphate) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 19.7 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 13.79 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.23 mg/kg No observed adverse effect level (mg/kg) NOAEL = 15 mg/kg (rat, 15-week, oral) Margin of Safety NOAEL / SED = 65 3.3.14. Discussion Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances.","endpoint":"dermal absorption","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 15","page":28,"route":"oral","species":"rat","study_id":"sccp_o_043_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=15; DOSE=SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed ad...; EFFECT=SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw of 2-amino-4-hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and so was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicit; CITATION=Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats; CITATION_NUMBERS=[27,90,2,50,100,1380]; REFERENCE=Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats; DETAILS_JSON={"cas_number":"83763-47-7","citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats","dose":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed ad...","duration":"subchronic","effect":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 18 Based on the adverse effects noted at 50 mg/kg bw, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw of 2-amino-4-hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and so was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicit","endpoint":"repeated dose toxicity","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"15","page":18,"route":"oral","species":"rat","study_id":"sccp_o_043_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw | rat | dermal | 15 week | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_043; REPORT_TITLE=Opinion on 2-AMINO-4-HYDROXYETHYLAMINO-ANISOLE SULFATE COLIPA N° A84; OPINION_NUMBER=SCCP/0958/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=15; DOSE=SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 29 Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15mg/kg bw.; EFFECT=SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 29 Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15mg/kg bw. In a teratogenicity study, no treatment-related effects were noted in foetuses up to 150mg/kg bw. A Repeated Dose (28 days) in guinea pigs gave no indication of systemic toxic effects was noted up to the maximum technically achievable dose of 300 mg/kg bw. It is readily absorbed from the gastro-intestinal tract. Irritation The cutaneous and mucous membrane tests for irritation are unsatisfactory but suggest mild irritant potential under the test conditions. Sensitisation A LLNA indicates that the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83763-47-7","citation":"","dose":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 29 Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15mg/kg bw.","duration":"15 week","effect":"SCCP/0958/05 Opinion on 2-Amino-4-hydroxyethylaminoanisole sulfate ____________________________________________________________________________________________ 29 Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15mg/kg bw. In a teratogenicity study, no treatment-related effects were noted in foetuses up to 150mg/kg bw. A Repeated Dose (28 days) in guinea pigs gave no indication of systemic toxic effects was noted up to the maximum technically achievable dose of 300 mg/kg bw. It is readily absorbed from the gastro-intestinal tract. Irritation The cutaneous and mucous membrane tests for irritation are unsatisfactory but suggest mild irritant potential under the test conditions. Sensitisation A LLNA indicates that the","endpoint":"repeated dose toxicity","ingredient":"2-amino-4-hydroxyethylamino-anisole sulfate (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"15","page":29,"route":"dermal","species":"rat","study_id":"sccp_o_043_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_136; REPORT_TITLE=OPINION ON 2-Amino-4-hydroxyethylaminoanisole sulfate COLIPA n° A84; OPINION_NUMBER=SCCP/1172/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=15; DOSE=SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethyla...; EFFECT=SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and consequently was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.; CITATION=Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats; CITATION_NUMBERS=[27,90,2,50,100,1380]; REFERENCE=Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats; DETAILS_JSON={"cas_number":"83763-47-7","citation":"Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats","dose":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethyla...","duration":"subchronic","effect":"SCCP/1172/08 Opinion on 2-amino-4-hydroxyethylaminoanisole sulfate 20 Conclusion Based on the adverse effects noted at 50 mg/kg bw/day, evident as slight anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, a “no observed adverse effect level” (NOAEL) of 15 mg/kg bw/day of 2-amino-4- hydroethoxyethylamino-anisole sulfate was derived from this subchronic oral toxicity study in rats. Ref.: 27 In another 90 day repeated dose oral toxicity study, dose levels of 2, 50 and 100 (increased to 1380) mg/kg bw/day were administered to rats. The study was considered to have limitations, i.e. in study design and test substance specification, and consequently was not provided. 3.3.5.3. Chronic (> 12 months) toxicity No data 3.3.6. Mutagenicity / Genotoxicity 3.","endpoint":"repeated dose toxicity","ingredient":"2-Amino-4-hydroxyethylaminoanisole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":20,"route":"oral","species":"rat","study_id":"sccp_o_136_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw/day | rat | dermal | 15 week | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_136; REPORT_TITLE=OPINION ON 2-Amino-4-hydroxyethylaminoanisole sulfate COLIPA n° A84; OPINION_NUMBER=SCCP/1172/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=24 June 2008; VALUE_TEXT=15; DOSE=Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15 mg/kg bw/day.; EFFECT=(including calculation of the MoS) Not applicable 3.3.14. Discussion Taken from SCCP/0958/05 Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances. Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15 mg/kg bw/day. In a teratogenicity study, no treatment-related effects were noted in foetuses up to 150 mg/kg bw/day. A Repeated Dose (28 days) study in guinea pigs gave no indication of systemic toxic effects up to the maximum technically achievable dose of 300 mg/kg bw/day. It is readily absorbed from the gastro-intestinal tract. Irritation The cutaneous and mucous membrane tests for irritation are unsatisfactory but suggest mild irritant potential under the test conditions. Sensitisation A LLNA indicat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"83763-47-7","citation":"","dose":"Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15 mg/kg bw/day.","duration":"15 week","effect":"(including calculation of the MoS) Not applicable 3.3.14. Discussion Taken from SCCP/0958/05 Physico-chemical specifications 2-Amino-4-hydroxyethylamino-anisole sulfate is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2-amino-4- hydroxyethylamino-anisole sulfate in marketed products is not reported. The dye should not be used in combination with nitrosating substances. Toxicity A 15 week repeated dose study in rats provided a NOAEL of 15 mg/kg bw/day. In a teratogenicity study, no treatment-related effects were noted in foetuses up to 150 mg/kg bw/day. A Repeated Dose (28 days) study in guinea pigs gave no indication of systemic toxic effects up to the maximum technically achievable dose of 300 mg/kg bw/day. It is readily absorbed from the gastro-intestinal tract. Irritation The cutaneous and mucous membrane tests for irritation are unsatisfactory but suggest mild irritant potential under the test conditions. Sensitisation A LLNA indicat","endpoint":"repeated dose toxicity","ingredient":"2-Amino-4-hydroxyethylaminoanisole sulfate","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":29,"route":"dermal","species":"rat","study_id":"sccp_o_136_noael_005"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 0NK0KYZ30R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H14N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0NK0KYZ30R"} |
| openFDA substances | FDA UNII substance identifier | 0NK0KYZ30R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H14N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0NK0KYZ30R"} |
| openFDA substances | FDA UNII substance identifier | 0NK0KYZ30R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H14N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0NK0KYZ30R"} |
| openFDA substances | FDA UNII substance identifier | 0NK0KYZ30R | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C9H14N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0NK0KYZ30R"} |