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 1:111981. doi: 10.1016/j.fct.2021.111981. Epub 2021 Feb 10.
The existing information supports the use of these materials as described in this safety assessment. The 167 materials identified in this assessment were evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Target data, read-across analogs and TTC show that these materials are not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for their respective Cramer Classes (see Fig. 1 below) and the exposure to these materials is below the TTC. The skin sensitization endpoint was completed using the DST for non-reactive and reactive materials (900 μg/cm and 64 μg/cm, respectively); exposures are below the DST. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; these materials are not expected to be phototoxic/photoallergenic. The environmental endpoints were evaluated; the materials were found not to be PBT as per the IFRA Environmental Standards, and their risk quotients, based on their current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.
现有信息支持将这些材料按照本安全评估中的说明进行使用。本评估共对 167 种材料进行了遗传毒性、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评估。目标数据、结构类似物和 TTC 表明，这些材料预计不会具有遗传毒性。重复剂量、生殖和局部呼吸毒性终点是根据各自的 Cramer 类别（见下图 1）使用 TTC 进行评估的，并且这些材料的暴露量低于 TTC。皮肤致敏终点是使用非反应性和反应性材料的 DST 完成的（分别为 900μg/cm 和 64μg/cm）；暴露量低于 DST。光毒性/光过敏终点是基于紫外线光谱进行评估的；这些材料预计不会具有光毒性/光过敏。对环境终点进行了评估；根据 IFRA 环境标准，这些材料不被认为是持久性、生物蓄积性和毒性（PBT）物质，并且基于它们在欧洲和北美的当前用量（即 PEC/PNEC），其风险商数<1。
