Update to RIFM fragrance ingredient safety assessment, hydroxycitronellal dimethyl acetal, CAS Registry number 141-92-4

IF 3.9 3区医学 Q2 FOOD SCIENCE & TECHNOLOGY

Food and Chemical Toxicology Pub Date : 2025-05-09 DOI:10.1016/j.fct.2025.115529

A.M. Api , A. Bartlett , D. Belsito , D. Botelho , M. Bruze , A. Bryant-Friedrich , G.A. Burton , M.A. Cancellieri , H. Chon , M. Cronin , S. Crotty , M.L. Dagli , W. Dekant , C. Deodhar , K. Farrell , A.D. Fryer , L. Jones , K. Joshi , A. Lapczynski , D.L. Laskin , Y. Thakkar

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引用次数: 0

Abstract

Hydroxycitronellal dimethyl acetal was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data from read-across analog hydroxycitronellal diethyl acetal (CAS # 7779-94-4) show that hydroxycitronellal dimethyl acetal is not expected to be genotoxic. The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the Threshold of Toxicological Concern (TTC) for a Cramer Class I material, and the exposure to hydroxycitronellal dimethyl acetal is below the TTC (0.03 mg/kg/day, 0.03 mg/kg/day, and 1.4 mg/day, respectively). Data show that there are no safety concerns for hydroxycitronellal dimethyl acetal for skin sensitization under the current declared levels of use. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; hydroxycitronellal dimethyl acetal is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; hydroxycitronellal dimethyl acetal was found not to be Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards, and its risk quotients (RQs), 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.

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更新RIFM香料成分安全性评估，羟基香茅醛二甲基缩醛，CAS注册号141-92-4

对羟基香茅醛二甲基缩醛的遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光刺激/光致敏性、皮肤致敏性和环境安全性进行了评价。读取类似物羟基香茅醛二乙基缩醛（CAS # 7779-94-4）的数据表明，羟基香茅醛二甲基缩醛预计不会具有遗传毒性。使用克莱默I类材料的毒理学关注阈值（TTC）评估了重复剂量，生殖和局部呼吸毒性终点，羟基香茅醛二甲基缩醛暴露低于TTC（分别为0.03 mg/kg/day， 0.03 mg/kg/day和1.4 mg/day）。数据显示，在目前宣布的使用水平下，羟基香茅醛二甲基缩醛对皮肤致敏没有安全问题。根据紫外/可见（UV/Vis）光谱评估光刺激/光致敏性终点；羟基香茅醛二甲基缩醛不具有光刺激/光致敏性。评估环境终点；根据国际香精协会（IFRA）环境标准，羟基香精二甲基缩醛被发现不具有持久性、生物蓄积性和毒性（PBT），其风险商数（RQs）基于其在欧洲和北美的当前使用量（VoU）（即预测环境浓度/预测无影响浓度[PEC/PNEC]）为1。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Food and Chemical Toxicology 工程技术-毒理学

CiteScore

10.90

自引率

4.70%

发文量

651

审稿时长

31 days

期刊介绍： Food and Chemical Toxicology (FCT), an internationally renowned journal, that publishes original research articles and reviews on toxic effects, in animals and humans, of natural or synthetic chemicals occurring in the human environment with particular emphasis on food, drugs, and chemicals, including agricultural and industrial safety, and consumer product safety. Areas such as safety evaluation of novel foods and ingredients, biotechnologically-derived products, and nanomaterials are included in the scope of the journal. FCT also encourages submission of papers on inter-relationships between nutrition and toxicology and on in vitro techniques, particularly those fostering the 3 Rs. The principal aim of the journal is to publish high impact, scholarly work and to serve as a multidisciplinary forum for research in toxicology. Papers submitted will be judged on the basis of scientific originality and contribution to the field, quality and subject matter. Studies should address at least one of the following: -Adverse physiological/biochemical, or pathological changes induced by specific defined substances -New techniques for assessing potential toxicity, including molecular biology -Mechanisms underlying toxic phenomena -Toxicological examinations of specific chemicals or consumer products, both those showing adverse effects and those demonstrating safety, that meet current standards of scientific acceptability. Authors must clearly and briefly identify what novel toxic effect (s) or toxic mechanism (s) of the chemical are being reported and what their significance is in the abstract. Furthermore, sufficient doses should be included in order to provide information on NOAEL/LOAEL values.