NOAEL Studies Cosmetic Ingredient

3-Amino-2,6-Dimethylphenol NOAEL Studies

INCI: 3-AMINO-2,6-DIMETHYLPHENOL

CAS: 6994-64-5

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 46, 47 3","dose":"No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.","effect":"y of thyroid follicular cells and no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity:","page":21,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_001"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day - - - NOAEL study {"dose":"he treatment with the test item even though no dose dependency could be observed.","effect":"he treatment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg","page":26,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_003"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"ubmitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formu","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_006"}
SCCS_vision_codex NOAEL =60 mg/kg bw/d rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"tigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulation","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_007"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_009"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"nt and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_011"}
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 46, 47 3","dose":"No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.","effect":"y of thyroid follicular cells and no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity:","page":21,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_001"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day - - - NOAEL study {"dose":"he treatment with the test item even though no dose dependency could be observed.","effect":"he treatment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg","page":26,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_003"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"ubmitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formu","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_006"}
SCCS_vision_codex NOAEL =60 mg/kg bw/d rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"tigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulation","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_007"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_009"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"nt and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_011"}
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 46, 47 3","dose":"No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.","effect":"y of thyroid follicular cells and no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity:","page":21,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_001"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day - - - NOAEL study {"dose":"he treatment with the test item even though no dose dependency could be observed.","effect":"he treatment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg","page":26,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_003"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"ubmitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formu","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_006"}
SCCS_vision_codex NOAEL =60 mg/kg bw/d rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"tigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulation","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_007"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_009"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"nt and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_011"}
SCCS_vision_codex NOAEL =70 mg/kg bw/day rat - Chronic genotoxicity {"citation":"Ref.: 46, 47 3","dose":"No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.","effect":"y of thyroid follicular cells and no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity:","page":21,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_001"}
SCCS_vision_codex NOAEL =150 mg/kg bw/day - - - NOAEL study {"dose":"he treatment with the test item even though no dose dependency could be observed.","effect":"he treatment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg","page":26,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_003"}
SCCS_vision_codex NOAEL =0.08 mg/kg bw rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"ubmitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formu","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_006"}
SCCS_vision_codex NOAEL =60 mg/kg bw/d rat dermal prenatal developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","effect":"tigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulation","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_007"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_009"}
SCCS_vision_codex NOAEL =60 mg/kg bw/day rat oral 14 days reproductive toxicity {"dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","effect":"nt and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","page":34,"pdf":"sccs_o_151.pdf","row_type":"noael_study","study_id":"sccs_o_151_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 150 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=150; DOSE=he treatment with the test item even though no dose dependency could be observed.; EFFECT=he treatment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"he treatment with the test item even though no dose dependency could be observed.","duration":"","effect":"he treatment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg","endpoint":"","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":26,"route":"","species":"","study_id":"sccs_o_151_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 150 mg/kg bw/day - - - - SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=150; DOSE=tment with the test item even though no dose dependency could be observed.; EFFECT=tment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"tment with the test item even though no dose dependency could be observed.","duration":"","effect":"tment with the test item even though no dose dependency could be observed. During visceral examination of foetuses, there was a dose-dependent increase in the incidence of an enlarged thyroid at 150 and 400 mg/kg bw/day. The treatment with the test item did not affect the pre- and post-implantation, the sex ratios and the number of foetuses at any dose level. At 60 mg/kg bw/day, no test item-related changes were observed. Conclusion Based on the effects in the dams observed at 400 and 150 mg/kg bw/day, the NOAEL (no observed adverse effect level) for maternal toxicity of 3-amino-2,6-dimethylphenol was considered to be 60 mg/kg bw/day. Based on the described effects in foetuses (body weight reduction and higher incidence of supernumerary and/or rudimentary ribs) at 400 mg/kg","endpoint":"","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":26,"route":"","species":"","study_id":"sccs_o_151_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 150 mg/kg bw/day human - - - SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=150; DOSE=SCCS/1529/14 Revision of 18 June 2014 Revision of the opinion on 3-amino-2,6-dimethylphenol (A162) ___________________________________________________________________________________________ 27 bw/day and increased incidence of enlarged thyroids observed at 400 and 150 mg/kg bw/day), the NOAEL for the foetuses was considered to be 60 mg/kg bw/day.; EFFECT=SCCS/1529/14 Revision of 18 June 2014 Revision of the opinion on 3-amino-2,6-dimethylphenol (A162) ___________________________________________________________________________________________ 27 bw/day and increased incidence of enlarged thyroids observed at 400 and 150 mg/kg bw/day), the NOAEL for the foetuses was considered to be 60 mg/kg bw/day. Ref.: 41 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in vitro Bioavailability across intestinal barrier in CaCo-2 (human intestinal epithelial carcinoma) cells Guideline: / Cells: Human intestinal epithelial cell line CaCo-2 (subclone HTB 37) Replicates: Two independent experiments Test substance: 3-Amino-2,6-dimethylphenol Batch No.: GST 083-04/70-07 Purity: 99.2 area% (HPLC at 254 nm), for details see 2.4. Test concentration: 50 µM (equivalent to 6.86; CITATION=Ref.: 41 3; CITATION_NUMBERS=[41,3]; REFERENCE=Ref.: 41 3; DETAILS_JSON={"cas_number":"6994-64-5","citation":"Ref.: 41 3","dose":"SCCS/1529/14 Revision of 18 June 2014 Revision of the opinion on 3-amino-2,6-dimethylphenol (A162) ___________________________________________________________________________________________ 27 bw/day and increased incidence of enlarged thyroids observed at 400 and 150 mg/kg bw/day), the NOAEL for the foetuses was considered to be 60 mg/kg bw/day.","duration":"","effect":"SCCS/1529/14 Revision of 18 June 2014 Revision of the opinion on 3-amino-2,6-dimethylphenol (A162) ___________________________________________________________________________________________ 27 bw/day and increased incidence of enlarged thyroids observed at 400 and 150 mg/kg bw/day), the NOAEL for the foetuses was considered to be 60 mg/kg bw/day. Ref.: 41 3.3.9. Toxicokinetics 3.3.9.1. Toxicokinetics in vitro Bioavailability across intestinal barrier in CaCo-2 (human intestinal epithelial carcinoma) cells Guideline: / Cells: Human intestinal epithelial cell line CaCo-2 (subclone HTB 37) Replicates: Two independent experiments Test substance: 3-Amino-2,6-dimethylphenol Batch No.: GST 083-04/70-07 Purity: 99.2 area% (HPLC at 254 nm), for details see 2.4. Test concentration: 50 µM (equivalent to 6.86","endpoint":"","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":27,"route":"","species":"human","study_id":"sccs_o_151_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =0.08 mg/kg bw rat dermal prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT== 0.08; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...; EFFECT=ubmitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","duration":"prenatal","effect":"ubmitted. 3.3.12. Special investigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formu","endpoint":"developmental toxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.08","page":34,"route":"dermal","species":"rat","study_id":"sccs_o_151_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =60 mg/kg bw/d rat dermal prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT== 60; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...; EFFECT=tigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulation; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical...","duration":"prenatal","effect":"tigations No data submitted. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulation","endpoint":"developmental toxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 60","page":34,"route":"dermal","species":"rat","study_id":"sccs_o_151_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =60 mg/kg bw/d rat oral prenatal developmental toxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT== 60; DOSE=he MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposu...; EFFECT=he MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"he MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposu...","duration":"prenatal","effect":"he MoS) CALCULATION OF THE MARGIN OF SAFETY (3-amino-2,6-dimethylphenol) (under oxidative conditions) Absorption through the skin (pig in vitro) A = 8.43 µg/cm² (maximum absorption 6.59 + 2 x 0.92 (2 SD)) Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.89 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.08 mg/kg bw No observed adverse effect level NOAEL = 60 mg/kg bw/d (rat, prenatal developmental toxicity study) Margin of Safety NOAEL/SED = 740 3.3.14. Discussion Physico-chemical properties 3-Amino-2,6-dimethylphenol is used as an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral a","endpoint":"developmental toxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 60","page":34,"route":"oral","species":"rat","study_id":"sccs_o_151_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 70 mg/kg bw/day rat - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=70; DOSE=No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.; EFFECT=y of thyroid follicular cells and no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity:; CITATION=Ref.: 46, 47 3; CITATION_NUMBERS=[46,47,3]; REFERENCE=Ref.: 46, 47 3; DETAILS_JSON={"cas_number":"6994-64-5","citation":"Ref.: 46, 47 3","dose":"No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.","duration":"Chronic","effect":"y of thyroid follicular cells and no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity:","endpoint":"genotoxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":21,"route":"","species":"rat","study_id":"sccs_o_151_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 70 mg/kg bw/day rat - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=70; DOSE=No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.; EFFECT=no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity: 99.7 ar; CITATION=Ref.: 46, 47 3; CITATION_NUMBERS=[46,47,3]; REFERENCE=Ref.: 46, 47 3; DETAILS_JSON={"cas_number":"6994-64-5","citation":"Ref.: 46, 47 3","dose":"No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol.","duration":"Chronic","effect":"no biologically relevant effect on thyroid hormones were observed in either male or female rats. No test item-related adverse effects were observed in the animals treated with 70 mg/kg bw/day of 3-amino-2,6-dimethylphenol. Conclusion Treatment with 3-amino-2,6-dimethylphenol at doses of 630 and 210 mg/kg bw/day resulted in adverse effects in liver, kidney, and the haematopoietic system. Since no treatment related changes of toxicological concern were noted at 70 mg/kg bw/day, the No Observed Adverse Effect Level (NOAEL) for 3-amino-2,6-dimethylphenol was concluded to be 70 mg/kg bw/day. Ref.: 46, 47 3.3.5.3. Chronic (> 12 months) toxicity No data submitted. 3.3.6. Mutagenicity / genotoxicity 3.3.6.1 Mutagenicity / genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1997) Test system: Salmonella typhimurium TA 98, TA 100, TA 102 TA 1535, TA 1537 Replicates: triplicates per test concentration Test substance: 3-Amino-2,6-dimethylphenol (WR803169) Solvent: DMSO Batch: GST 083-04/70-07 Purity: 99.7 ar","endpoint":"genotoxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":21,"route":"","species":"rat","study_id":"sccs_o_151_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 2000 mg/kg bw rat oral 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=2000; DOSE=General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.; EFFECT=an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","duration":"14 days","effect":"an oxidative hair colouring agent (coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":34,"route":"oral","species":"rat","study_id":"sccs_o_151_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 70 mg/kg bw/day rat oral 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=70; DOSE=General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.; EFFECT=(coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","duration":"14 days","effect":"(coupler). The intended maximum on-head concentration is 2.0% in oxidative hair dye formulations. The oxidative colouring agent and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"70","page":34,"route":"oral","species":"rat","study_id":"sccs_o_151_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 60 mg/kg bw/day rat oral 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=60; DOSE=General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.; EFFECT=nt and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","duration":"14 days","effect":"nt and the developer are mixed at a ratio of 1+1 to 1+3 (g dye formulation + g developer formulation). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":34,"route":"oral","species":"rat","study_id":"sccs_o_151_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies reproductive toxicity 60 mg/kg bw/day rat oral 14 days reproductive toxicity SOURCE_SUBDIR=sccs_o_151; REPORT_TITLE=OPINION ON 3-amino-2,6-dimethylphenol COLIPA n° A162; OPINION_NUMBER=SCCS/1529/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=18 June 2014; VALUE_TEXT=60; DOSE=General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.; EFFECT=). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"6994-64-5","citation":"","dose":"General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw.","duration":"14 days","effect":"). Stability of 3-amino-2,6-dimethylphenol in typical hair dye formulations is not reported. General toxicity After 14 days observation, the LD50 after oral administration to female rats was reported to be between 300 and 2000 mg/kg bw. In a 90-day study, the No Observed Adverse Effect Level (NOAEL) in rats after oral gavage was 70 mg/kg bw/day. Based on a prenatal developmental toxicity study in pregnant rats, the NOAEL after oral administration was 60 mg/kg bw/day both for maternal and for foetal toxicity. This NOAEL should be used for the calculation of MoS. No study on reproductive toxicity was provided.","endpoint":"reproductive toxicity","ingredient":"3-amino-2,6-dimethylphenol","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":34,"route":"oral","species":"rat","study_id":"sccs_o_151_noael_012"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier KK52J0MQ7D UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KK52J0MQ7D"}
openFDA substances FDA UNII substance identifier KK52J0MQ7D UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KK52J0MQ7D"}
openFDA substances FDA UNII substance identifier KK52J0MQ7D UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KK52J0MQ7D"}
openFDA substances FDA UNII substance identifier KK52J0MQ7D UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KK52J0MQ7D"}