NOAEL Studies Cosmetic Ingredient

2-Methyl-1-Naphthol NOAEL Studies

CAS: 7469-77-4

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

Back to parent ingredient page
COSMOS_DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 225 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCP; Oral (Gavage) Developmental Toxicity Study Of GTS03958 In Rats, P&G Study # 2718-53858, October 2005
COSMOS_DB NOAEL 75 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCP; Oral (Gavage) Developmental Toxicity Study Of GTS03958 In Rats, P&G Study # 2718-53858, October 2005
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =0.07 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1163/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculate","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_005"}
SCCS_vision_codex NOAEL =0.07 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1163/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculate","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_005"}
SCCS_vision_codex NOAEL =0.07 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1163/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculate","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_005"}
SCCS_vision_codex NOAEL =0.07 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"SCCP/1163/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculate","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_005"}
SCCS_vision_codex NOAEL =75 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"and gestation periods. Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_003"}
SCCS_vision_codex NOAEL =75 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"3/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated valu","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_006"}
SCCS_vision_codex NOAEL =75 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"and gestation periods. Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_003"}
SCCS_vision_codex NOAEL =75 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"3/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated valu","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_006"}
SCCS_vision_codex NOAEL =75 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"and gestation periods. Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_003"}
SCCS_vision_codex NOAEL =75 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"3/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated valu","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_006"}
SCCS_vision_codex NOAEL =75 mg/kg bw/day - oral developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"and gestation periods. Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_003"}
SCCS_vision_codex NOAEL =75 mg/kg bw rat oral - dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","effect":"3/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated valu","page":26,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_006"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral Chronic genotoxicity {"citation":"Ref.: 16 3","dose":"No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals.","effect":"Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 17 gavage-related. No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals. The mean percent sperm motility, caudal epididymal sperm count, and sperm morphology were not affected by treatment with GTS03958 at dosage levels of 6, 25, and 100 mg/kg bw/day. No biologically meaningful differences were observed between the study groups. Conclusion Based on the results of this study, the NOAEL was 100 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 Replicates: triplicates in a single experiment both in the presence and absence of metabolic activation Test substance: C 7634/342 Solvent: DMSO Batch: / Purity: / Concentrations: 3.3, 10, 33, 100, 333 and 1","page":17,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_002"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral Chronic genotoxicity {"citation":"Ref.: 16 3","dose":"No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals.","effect":"Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 17 gavage-related. No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals. The mean percent sperm motility, caudal epididymal sperm count, and sperm morphology were not affected by treatment with GTS03958 at dosage levels of 6, 25, and 100 mg/kg bw/day. No biologically meaningful differences were observed between the study groups. Conclusion Based on the results of this study, the NOAEL was 100 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 Replicates: triplicates in a single experiment both in the presence and absence of metabolic activation Test substance: C 7634/342 Solvent: DMSO Batch: / Purity: / Concentrations: 3.3, 10, 33, 100, 333 and 1","page":17,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_002"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral Chronic genotoxicity {"citation":"Ref.: 16 3","dose":"No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals.","effect":"Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 17 gavage-related. No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals. The mean percent sperm motility, caudal epididymal sperm count, and sperm morphology were not affected by treatment with GTS03958 at dosage levels of 6, 25, and 100 mg/kg bw/day. No biologically meaningful differences were observed between the study groups. Conclusion Based on the results of this study, the NOAEL was 100 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 Replicates: triplicates in a single experiment both in the presence and absence of metabolic activation Test substance: C 7634/342 Solvent: DMSO Batch: / Purity: / Concentrations: 3.3, 10, 33, 100, 333 and 1","page":17,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_002"}
SCCS_vision_codex NOAEL =100 mg/kg bw/day - oral Chronic genotoxicity {"citation":"Ref.: 16 3","dose":"No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals.","effect":"Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 17 gavage-related. No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals. The mean percent sperm motility, caudal epididymal sperm count, and sperm morphology were not affected by treatment with GTS03958 at dosage levels of 6, 25, and 100 mg/kg bw/day. No biologically meaningful differences were observed between the study groups. Conclusion Based on the results of this study, the NOAEL was 100 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 Replicates: triplicates in a single experiment both in the presence and absence of metabolic activation Test substance: C 7634/342 Solvent: DMSO Batch: / Purity: / Concentrations: 3.3, 10, 33, 100, 333 and 1","page":17,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_002"}
SCCS_vision_codex NOAEL =225 mg/kg bw/day - - developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in the 500 mg/kg bw/day dosage group. Three total litter losses","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_004"}
SCCS_vision_codex NOAEL =225 mg/kg bw/day - - developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in the 500 mg/kg bw/day dosage group. Three total litter losses","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_004"}
SCCS_vision_codex NOAEL =225 mg/kg bw/day - - developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in the 500 mg/kg bw/day dosage group. Three total litter losses","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_004"}
SCCS_vision_codex NOAEL =225 mg/kg bw/day - - developmental developmental toxicity {"citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","effect":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in the 500 mg/kg bw/day dosage group. Three total litter losses","page":25,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_004"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat oral 14-days repeated dose toxicity {"citation":"Ref: 15 3","dose":"Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day.","effect":"s associated with mildly lower haemoglobin values for males, moderately higher absolute reticulocyte count for males and females, and mildly lower urine pH for males. Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day. No test article-related mortality, organ weight changes or macroscopic findings were observed in this study. Based on the results of this 14-days oral toxicity study, the study authors derived an NOAEL 500 mg/kg bw/day. Ref: 15 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague Dawley rats (Crl:CD(SD)IGS BR) Group size: vehicle (40/group, 20/sex), 6 mg/kg bw/day (30/group, 15/sex), 25 mg/kg bw/day (30/group, 15/sex), 100 mg/kg bw/day (40/group, 20/sex), Test substance: GTS03958 Batch: 1083099","page":15,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat oral 14-days repeated dose toxicity {"citation":"Ref: 15 3","dose":"Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day.","effect":"s associated with mildly lower haemoglobin values for males, moderately higher absolute reticulocyte count for males and females, and mildly lower urine pH for males. Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day. No test article-related mortality, organ weight changes or macroscopic findings were observed in this study. Based on the results of this 14-days oral toxicity study, the study authors derived an NOAEL 500 mg/kg bw/day. Ref: 15 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague Dawley rats (Crl:CD(SD)IGS BR) Group size: vehicle (40/group, 20/sex), 6 mg/kg bw/day (30/group, 15/sex), 25 mg/kg bw/day (30/group, 15/sex), 100 mg/kg bw/day (40/group, 20/sex), Test substance: GTS03958 Batch: 1083099","page":15,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat oral 14-days repeated dose toxicity {"citation":"Ref: 15 3","dose":"Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day.","effect":"s associated with mildly lower haemoglobin values for males, moderately higher absolute reticulocyte count for males and females, and mildly lower urine pH for males. Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day. No test article-related mortality, organ weight changes or macroscopic findings were observed in this study. Based on the results of this 14-days oral toxicity study, the study authors derived an NOAEL 500 mg/kg bw/day. Ref: 15 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague Dawley rats (Crl:CD(SD)IGS BR) Group size: vehicle (40/group, 20/sex), 6 mg/kg bw/day (30/group, 15/sex), 25 mg/kg bw/day (30/group, 15/sex), 100 mg/kg bw/day (40/group, 20/sex), Test substance: GTS03958 Batch: 1083099","page":15,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/day rat oral 14-days repeated dose toxicity {"citation":"Ref: 15 3","dose":"Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day.","effect":"s associated with mildly lower haemoglobin values for males, moderately higher absolute reticulocyte count for males and females, and mildly lower urine pH for males. Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day. No test article-related mortality, organ weight changes or macroscopic findings were observed in this study. Based on the results of this 14-days oral toxicity study, the study authors derived an NOAEL 500 mg/kg bw/day. Ref: 15 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague Dawley rats (Crl:CD(SD)IGS BR) Group size: vehicle (40/group, 20/sex), 6 mg/kg bw/day (30/group, 15/sex), 25 mg/kg bw/day (30/group, 15/sex), 100 mg/kg bw/day (40/group, 20/sex), Test substance: GTS03958 Batch: 1083099","page":15,"pdf":"sccp_o_154.pdf","row_type":"noael_study","study_id":"sccp_o_154_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 11 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.07 mg/kg bw rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT== 0.07; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=SCCP/1163/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculate; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7469-77-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"","effect":"SCCP/1163/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculate","endpoint":"dermal absorption","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.07","page":26,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =75 mg/kg bw rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT== 75; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=3/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated valu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7469-77-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"","effect":"3/08 Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated valu","endpoint":"dermal absorption","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 75","page":26,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =75 mg/kg bw rat oral - dermal absorption SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT== 75; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...; EFFECT=thalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated value of Log Pow, without any reference to the respective pH, cannot be c; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7469-77-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure do...","duration":"","effect":"thalene) 26 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 2-methyl-1-naphthol (oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 5.73 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 4.01 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.07 mg/kg bw No observed adverse effect level NOAEL = 75 mg/kg bw (maternal toxicity, oral, rat) Margin of Safety NOAEL / SED = 1071 3.3.14. Discussion Physico-chemical properties 2-Methyl-1-naphthol is used in oxidative hair dye formulations at levels up to 4% (2% on- head). The coded test substance used in many of the submitted studies was not specifically identified as 2-methyl-1-naphthol and no information was provided on its purity. The Pow strongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated value of Log Pow, without any reference to the respective pH, cannot be c","endpoint":"dermal absorption","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 75","page":26,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 75 mg/kg bw/day - oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=75; DOSE=Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.; EFFECT=and gestation periods. Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in; CITATION=Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22); CITATION_NUMBERS=[23,22]; REFERENCE=Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22); DETAILS_JSON={"cas_number":"7469-77-4","citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","duration":"developmental","effect":"and gestation periods. Absolute and relative feed consumption values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in","endpoint":"developmental toxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":25,"route":"oral","species":"","study_id":"sccp_o_154_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 75 mg/kg bw/day rat oral 14-day developmental toxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=75; DOSE=General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.; EFFECT=SCCS-rejected applicant NOAEL: ned by the EU method. No documentation is provided for the reported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or internationally accepted test guidelines and/or test material analytical characterisation was not documented. These studies were not considered to be in line with current requirements and do not provide additional information. Irritation / sensitisation The test substance (2-methyl-1-naphthol) was irritant to rabbit skin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7469-77-4","citation":"","dose":"General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.","duration":"14-day","effect":"SCCS-rejected applicant NOAEL: ned by the EU method. No documentation is provided for the reported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or internationally accepted test guidelines and/or test material analytical characterisation was not documented. These studies were not considered to be in line with current requirements and do not provide additional information. Irritation / sensitisation The test substance (2-methyl-1-naphthol) was irritant to rabbit skin","endpoint":"developmental toxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":26,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg bw/day rat oral 14-day developmental toxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=100; DOSE=General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.; EFFECT=SCCS-rejected applicant NOAEL: l conditions and to the pH conditions of the percutaneous absorption studies. Solubility in water is not determined by the EU method. No documentation is provided for the reported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or internationally accepted test guidelines and/or test material analytical characterisation was not documented. These studies were not considered to be in line with current requirements and do not provide additiona; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7469-77-4","citation":"","dose":"General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.","duration":"14-day","effect":"SCCS-rejected applicant NOAEL: l conditions and to the pH conditions of the percutaneous absorption studies. Solubility in water is not determined by the EU method. No documentation is provided for the reported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or internationally accepted test guidelines and/or test material analytical characterisation was not documented. These studies were not considered to be in line with current requirements and do not provide additiona","endpoint":"developmental toxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":26,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 225 mg/kg bw/day - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=225; DOSE=values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.; EFFECT=values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in the 500 mg/kg bw/day dosage group. Three total litter losses; CITATION=Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22); CITATION_NUMBERS=[23,22]; REFERENCE=Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22); DETAILS_JSON={"cas_number":"7469-77-4","citation":"Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22)","dose":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period.","duration":"developmental","effect":"values were significantly reduced in the 225 mg/kg/day dosage group on DGs 6 to 9 and 9 to 12, as well as during the entire dosage period. No Caesarean-sectioning or litter parameters were affected by dosages of GTS03958 as high as 225 mg/kg bw/day. No gross external, soft tissue or skeletal alterations were caused by dosages of GTS03958 as high as 225 mg/kg bw/day. Conclusion On the basis of these data, the maternal no-observable-adverse-effect-level (NOAEL) for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. Ref.: 23 Comment The dose levels in this study were based on the results of a dose-range finding study (reference 22). In this study animals were exposed to 0, 25, 75, 200 and 500 mg/kg bw/day GTS03958 (8 animals per group). Maternal body weight gain was decreased in the 200 and 500 mg/kg bw/d groups. Mean litter sizes and live foetuses were decreased and resorptions and the percentage of dams with any resorptions were increased in the 500 mg/kg bw/day dosage group. Three total litter losses","endpoint":"developmental toxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"225","page":25,"route":"","species":"","study_id":"sccp_o_154_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 225 mg/kg bw/day rat oral 14-day developmental toxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=225; DOSE=General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.; EFFECT=SCCS-rejected applicant NOAEL: ported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or internationally accepted test guidelines and/or test material analytical characterisation was not documented. These studies were not considered to be in line with current requirements and do not provide additional information. Irritation / sensitisation The test substance (2-methyl-1-naphthol) was irritant to rabbit skin under the described conditions. The neat substance caused re; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7469-77-4","citation":"","dose":"General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.","duration":"14-day","effect":"SCCS-rejected applicant NOAEL: ported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or internationally accepted test guidelines and/or test material analytical characterisation was not documented. These studies were not considered to be in line with current requirements and do not provide additional information. Irritation / sensitisation The test substance (2-methyl-1-naphthol) was irritant to rabbit skin under the described conditions. The neat substance caused re","endpoint":"developmental toxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"225","page":26,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 500 mg/kg bw/day rat oral 14-day developmental toxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=500; DOSE=General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.; EFFECT=rongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. Solubility in water is not determined by the EU method. No documentation is provided for the reported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or inte; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7469-77-4","citation":"","dose":"General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day.","duration":"14-day","effect":"rongly depends on the pH, especially for ionisable molecules, zwitterions etc. Therefore, a single calculated value of Log Pow, without any reference to the respective pH, cannot be correlated to physiological conditions and to the pH conditions of the percutaneous absorption studies. Solubility in water is not determined by the EU method. No documentation is provided for the reported stability of 2-methyl-1-naphthol in marketed products. General toxicity Based on the results of a 14-day oral toxicity study, the NOAEL following oral gavage administration of GTS03958 at doses of 10, 40, 150 or 500 mg/kg bw/day to rats for 15 days was 500 mg/kg bw/day. Based on the results of 3-months oral (gavage) toxicity studies an NOAEL of 100 mg/kg bw/day (highest dose tested) was established. In a developmental study in rats, the maternal NOAEL for GTS03958 is 75 mg/kg bw/day, and the developmental NOAEL is 225 mg/kg bw/day. A few studies were submitted which were stated in the submission to be not conducted in compliance with OECD or inte","endpoint":"developmental toxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":26,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 100 mg/kg bw/day - oral Chronic genotoxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=100; DOSE=No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals.; EFFECT=Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 17 gavage-related. No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals. The mean percent sperm motility, caudal epididymal sperm count, and sperm morphology were not affected by treatment with GTS03958 at dosage levels of 6, 25, and 100 mg/kg bw/day. No biologically meaningful differences were observed between the study groups. Conclusion Based on the results of this study, the NOAEL was 100 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 Replicates: triplicates in a single experiment both in the presence and absence of metabolic activation Test substance: C 7634/342 Solvent: DMSO Batch: / Purity: / Concentrations: 3.3, 10, 33, 100, 333 and 1; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"7469-77-4","citation":"Ref.: 16 3","dose":"No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals.","duration":"Chronic","effect":"Opinion on 2-methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene) 17 gavage-related. No target organs/tissues were identified for examination from the lower dose groups or recovery sacrifice animals. The mean percent sperm motility, caudal epididymal sperm count, and sperm morphology were not affected by treatment with GTS03958 at dosage levels of 6, 25, and 100 mg/kg bw/day. No biologically meaningful differences were observed between the study groups. Conclusion Based on the results of this study, the NOAEL was 100 mg/kg bw/day. Ref.: 16 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Test Guideline: OECD 471 (1983) Species/strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 Replicates: triplicates in a single experiment both in the presence and absence of metabolic activation Test substance: C 7634/342 Solvent: DMSO Batch: / Purity: / Concentrations: 3.3, 10, 33, 100, 333 and 1","endpoint":"genotoxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":17,"route":"oral","species":"","study_id":"sccp_o_154_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 500 mg/kg bw/day rat oral 14-days repeated dose toxicity SOURCE_SUBDIR=sccp_o_154; REPORT_TITLE=OPINION ON 2-Methyl-1-naphthol (including 1-acetoxy-2-methylnaphthalene, A153) COLIPA n° A156; OPINION_NUMBER=SCCP/1163/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=16 December 2008; VALUE_TEXT=500; DOSE=Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day.; EFFECT=s associated with mildly lower haemoglobin values for males, moderately higher absolute reticulocyte count for males and females, and mildly lower urine pH for males. Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day. No test article-related mortality, organ weight changes or macroscopic findings were observed in this study. Based on the results of this 14-days oral toxicity study, the study authors derived an NOAEL 500 mg/kg bw/day. Ref: 15 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague Dawley rats (Crl:CD(SD)IGS BR) Group size: vehicle (40/group, 20/sex), 6 mg/kg bw/day (30/group, 15/sex), 25 mg/kg bw/day (30/group, 15/sex), 100 mg/kg bw/day (40/group, 20/sex), Test substance: GTS03958 Batch: 1083099; CITATION=Ref: 15 3; CITATION_NUMBERS=[15,3]; REFERENCE=Ref: 15 3; DETAILS_JSON={"cas_number":"7469-77-4","citation":"Ref: 15 3","dose":"Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day.","duration":"14-days","effect":"s associated with mildly lower haemoglobin values for males, moderately higher absolute reticulocyte count for males and females, and mildly lower urine pH for males. Of uncertain relationship to test article administration was the occurrence of discoloured urine (red) for two males and one female given 500 mg/kg bw/day. No test article-related mortality, organ weight changes or macroscopic findings were observed in this study. Based on the results of this 14-days oral toxicity study, the study authors derived an NOAEL 500 mg/kg bw/day. Ref: 15 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague Dawley rats (Crl:CD(SD)IGS BR) Group size: vehicle (40/group, 20/sex), 6 mg/kg bw/day (30/group, 15/sex), 25 mg/kg bw/day (30/group, 15/sex), 100 mg/kg bw/day (40/group, 20/sex), Test substance: GTS03958 Batch: 1083099","endpoint":"repeated dose toxicity","ingredient":"1-acetoxy-2-methylnaphthalene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":15,"route":"oral","species":"rat","study_id":"sccp_o_154_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier COU5JQ433I UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"COU5JQ433I"}
openFDA substances FDA UNII substance identifier COU5JQ433I UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"COU5JQ433I"}
openFDA substances FDA UNII substance identifier COU5JQ433I UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"COU5JQ433I"}
openFDA substances FDA UNII substance identifier COU5JQ433I UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H10O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"COU5JQ433I"}