Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ, 07677, USA.
Member Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY, 10032, USA.
Food Chem Toxicol. 2021 Mar;149 Suppl 1:111992. doi: 10.1016/j.fct.2021.111992. Epub 2021 Jan 15.
The existing information supports the use of this material as described in this safety assessment. Glyceryl monooleate was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data show that glyceryl monooleate is not genotoxic. Data on glyceryl monooleate 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 reactive materials (64 μg/cm); exposure is below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on ultraviolet (UV) spectra; glyceryl monooleate 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 glyceryl monooleate is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; glyceryl monooleate 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 (VoU) 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评估中所述用途。已对单油酸甘油酯进行遗传毒性、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评估。数据表明，单油酸甘油酯没有遗传毒性。单油酸甘油酯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。皮肤致敏终点使用反应性物质的皮肤致敏阈值（DST）（64μg/cm）完成；接触量低于 DST。光毒性/光过敏终点基于紫外线（UV）光谱进行评估；预计单油酸甘油酯没有光毒性/光过敏。局部呼吸毒性终点使用毒性关注阈值（TTC）评估 Cramer 类 I 物质，单油酸甘油酯的接触量低于 TTC（1.4mg/天）。对环境终点进行了评估；根据国际香料协会（IFRA）环境标准，单油酸甘油酯不属于持久性、生物累积性和毒性物质（PBT），并且根据其在欧洲和北美的当前用量（VoU），其风险商数（基于其当前在欧洲和北美的用量）低于 1。
