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. 2022 Jan 15;159 Suppl 1:112715. doi: 10.1016/j.fct.2021.112715. Epub 2021 Nov 27.
The Research Institute for Fragrance Materials, Inc. (RIFM) has evaluated safety data for fragrance materials for 55 years. The safety assessment of Natural Complex Substances (NCS) is similar to that of discrete fragrance materials; all of the same endpoints are evaluated. A series of decision trees, reflecting advances in risk assessment approaches of mixtures and toxicological methodologies, follows a tiered approach for each endpoint using a 4-step process with testing only as a last resort: 1) evaluate available data on NCS; 2) verify whether the Threshold of Toxicological Concern (TTC) can be applied; 3) verify whether the NCS risk assessment can be achieved on a component basis; and 4) determine whether data must be generated. Using in silico tools, RIFM examined NCS similarities based on the plant part, processing, and composition of materials across 81 plant families to address data gaps. Data generated from the Creme RIFM Aggregate Exposure Model for over 900 fragrance NCS demonstrate that dermal exposure is the primary route of human exposure for NCS fragrance uses. Over a third of materials are below the most conservative TTC limits. This process aims to provide a comprehensive Safety Assessment of NCS used as a fragrance ingredient.
香味料研究协会（RIFM）已经对香味料进行了 55 年的安全数据评估。天然复合物质（NCS）的安全性评估与离散香味料相似；所有相同的终点都要进行评估。一系列决策树，反映了混合物风险评估方法和毒理学方法的进展，采用分级方法对每个终点进行评估，该方法使用 4 步程序，仅将测试作为最后手段：1）评估 NCS 的可用数据；2）验证是否可以应用毒理学关注阈值（TTC）；3）验证是否可以基于成分进行 NCS 风险评估；4）确定是否必须生成数据。RIFM 使用计算机工具，根据 81 个植物科的植物部位、加工和成分，检查 NCS 的相似性，以解决数据差距。超过 900 种香味 NCS 的 Creme RIFM 综合暴露模型生成的数据表明，皮肤接触是人类接触 NCS 香味用途的主要途径。超过三分之一的材料低于最保守的 TTC 限制。该过程旨在为用作香料成分的 NCS 提供全面的安全评估。
