The existing information supports the use of this material as described in this safety assessment. 4-Methylpentanoic acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog 2-ethylbutyric acid (CAS # 88-09-5) show that 4-methylpentanoic acid is not expected to be genotoxic and provide a calculated margin of exposure (MOE) >100 for the repeated dose toxicity and reproductive toxicity endpoints. The skin sensitization endpoint was completed using the dermal sensitization threshold (DST) for non-reactive materials (900 μg/cm²); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; 4-methylpentanoic acid is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the threshold of toxicological concern (TTC) for a Cramer Class I material, and the exposure to 4-methylpentanoic acid is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; 4-methylpentanoic acid was found not to be persistent, bioaccumulative, and toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., Predicted Environmental Concentration/Predicted No Effect Concentration [PEC/PNEC]), are <1.

现有信息支持本安全评估中所述材料的使用。评价4-甲基戊酸的遗传毒性，重复剂量毒性，生殖毒性，局部呼吸毒性，光毒性/光致敏性，皮肤致敏性和环境安全性。交叉读取的类似物2-乙基丁酸（CAS＃88-09-5）的数据表明，预期4-甲基戊酸不具有遗传毒性，对于重复剂量毒性和生殖作用，其计算出的暴露裕度（MOE）> 100毒性终点。使用非反应性物质（900μg/ cm ²的皮肤致敏性阈值（DST））完成皮肤致敏性终点）; 曝光低于DST。基于紫外线（UV）光谱评估了光毒性/光致敏性终点；预计4-甲基戊酸不会产生光毒性/光致过敏性。对于Cramer I类物质，使用毒理学关注阈值（TTC）评估了局部呼吸毒性终点，并且暴露于4-甲基戊酸的暴露低于TTC（1.4 mg /天）。评估了环境指标；根据国际香水协会（IFRA）环境标准及其风险商，根据其目前在欧洲和北美的使用量，发现4-甲基戊酸不是持久性，生物蓄积性和有毒的（PBT）。预测的环境浓度/预测的无效浓度[PEC / PNEC]）小于1。