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IFRA 香料成分安全评估,癸酸,CAS 注册号 334-48-5。

RIFM fragrance ingredient safety assessment, decanoic acid, CAS Registry Number 334-48-5.

机构信息

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.

出版信息

Food Chem Toxicol. 2020 Oct 15;144 Suppl 1:111465. doi: 10.1016/j.fct.2020.111465. Epub 2020 Jul 5.

Abstract

The existing information supports the use of this material as described in this safety assessment. Decanoic acid was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, phototoxicity/photoallergenicity, skin sensitization, and environmental safety. Data on the target material and from read-across analog nonanoic acid (CAS # 112-05-0) show that decanoic acid is not expected to be genotoxic. Data on read-across analog octanoic acid (CAS # 124-07-2) provide a calculated MOE >100 for the repeated dose and reproductive toxicity endpoints. Based on the existing data, decanoic acid does not present a concern for skin sensitization under the current, declared levels of use. The phototoxicity/photoallergenicity endpoints were evaluated based on UV spectra; decanoic acid is not expected to be phototoxic/photoallergenic. The local respiratory toxicity endpoint was evaluated using the TTC for a Cramer Class I material, and the exposure to decanoic acid is below the TTC (1.4 mg/day). The environmental endpoints were evaluated; decanoic acid was found not to be PBT as per the IFRA Environmental Standards, and its risk quotients, based on its current volume of use in Europe and North America (i.e., PEC/PNEC), are <1.

摘要

现有信息支持将该材料按本安全性评估中的描述使用。已对癸酸进行遗传毒性、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。关于目标物质和来自类推物质壬酸(CAS#112-05-0)的数据表明,癸酸预计不会具有遗传毒性。来自类推物质己酸(CAS#124-07-2)的数据为重复剂量和生殖毒性终点提供了计算的 MOE>100。基于现有数据,在当前申报的使用水平下,癸酸不会引起皮肤致敏关注。光毒性/光过敏终点是根据紫外线光谱进行评估的;癸酸预计不会具有光毒性/光过敏。局部呼吸毒性终点是使用 Cramer 分类 I 物质的 TTC 进行评估的,而癸酸的暴露量低于 TTC(1.4mg/天)。已对环境终点进行评估;根据 IFRA 环境标准,癸酸不属于 PBT,其风险商数(基于其在欧洲和北美的当前用量)<1。

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