Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Member Expert Panel for Fragrance Safety, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2022 Sep;167 Suppl 1:113341. doi: 10.1016/j.fct.2022.113341. Epub 2022 Aug 5.
The existing information supports the use of this material as described in this safety assessment. Geraniol was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that geraniol is not genotoxic. Data on geraniol provide a calculated Margin of Exposure (MOE) > 100 for the repeated dose toxicity and reproductive toxicity endpoints. Data provided geraniol a No Expected Sensitization Induction Level (NESIL) of 11000 μg/cm for the skin sensitization endpoint. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; geraniol 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 geraniol is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; geraniol 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.
现有信息支持将该材料用于本安全性评估中所述用途。香叶醇的遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光毒性/光过敏、皮肤致敏和环境安全性已进行了评估。数据表明香叶醇没有遗传毒性。关于香叶醇的数据为重复剂量毒性和生殖毒性终点提供了计算暴露量倍数 (MOE) > 100。数据为香叶醇的皮肤致敏终点提供了 11000 μg/cm 的预计无致敏诱导水平 (NESIL)。光毒性/光过敏终点是基于紫外线/可见光 (UV/Vis) 光谱进行评估的；香叶醇预计不会具有光毒性/光过敏。局部呼吸毒性终点是使用毒性关注阈值 (TTC) 对 Cramer 分类 I 物质进行评估的，而香叶醇的暴露量低于 TTC（1.4 mg/天）。环境终点进行了评估；根据国际香料协会 (IFRA) 环境标准，香叶醇不属于持久性、生物累积性和毒性 (PBT)，并且基于其在欧洲和北美的当前用量，其风险商数（即预测环境浓度/无效应预测浓度 [PEC/PNEC]）<1。
