Api A M, Belsito D, Bruze M, Cadby P, Calow P, Dagli M L, Dekant W, Ellis G, Fryer A D, Fukayama M, Griem P, Hickey C, Kromidas L, Lalko J F, Liebler D C, Miyachi Y, Politano V T, Renskers K, Ritacco G, Salvito D, Schultz T W, Sipes I G, Smith B, Vitale D, Wilcox D K
Research Institute for Fragrance Materials, Inc., 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.
Member RIFM Expert Panel, Columbia University Medical Center, Department of Dermatology, 161 Fort Washington Ave., New York, NY 10032, USA.
Food Chem Toxicol. 2015 Aug;82 Suppl:S1-S19. doi: 10.1016/j.fct.2014.11.014. Epub 2014 Dec 12.
The Research Institute for Fragrance Materials, Inc. (RIFM) has been engaged in the generation and evaluation of safety data for fragrance materials since its inception over 45 years ago. Over time, RIFM's approach to gathering data, estimating exposure and assessing safety has evolved as the tools for risk assessment evolved. This publication is designed to update the RIFM safety assessment process, which follows a series of decision trees, reflecting advances in approaches in risk assessment and new and classical toxicological methodologies employed by RIFM over the past ten years. These changes include incorporating 1) new scientific information including a framework for choosing structural analogs, 2) consideration of the Threshold of Toxicological Concern (TTC), 3) the Quantitative Risk Assessment (QRA) for dermal sensitization, 4) the respiratory route of exposure, 5) aggregate exposure assessment methodology, 6) the latest methodology and approaches to risk assessments, 7) the latest alternatives to animal testing methodology and 8) environmental risk assessment. The assessment begins with a thorough analysis of existing data followed by in silico analysis, identification of 'read across' analogs, generation of additional data through in vitro testing as well as consideration of the TTC approach. If necessary, risk management may be considered.
香料成分研究所有限公司（RIFM）自45多年前成立以来，一直致力于香料成分安全数据的生成和评估。随着时间的推移，随着风险评估工具的发展，RIFM收集数据、估计暴露量和评估安全性的方法也在不断演变。本出版物旨在更新RIFM的安全评估流程，该流程遵循一系列决策树，反映了过去十年中风险评估方法的进展以及RIFM采用的新的和经典的毒理学方法。这些变化包括纳入1）新的科学信息，包括选择结构类似物的框架，2）毒理学关注阈值（TTC）的考虑，3）皮肤致敏的定量风险评估（QRA），4）呼吸道暴露途径，5）累积暴露评估方法，6）风险评估的最新方法和途径，7）动物试验方法的最新替代方法，以及8）环境风险评估。评估首先对现有数据进行全面分析，然后进行计算机模拟分析，识别“类推”类似物，通过体外试验生成额外数据，并考虑TTC方法。如有必要，可考虑风险管理。
