RIFM fragrance ingredient safety assessment, 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone, CAS Registry Number 61315-75-1.

IF 3.9 3区医学 Q2 FOOD SCIENCE & TECHNOLOGY Food and Chemical Toxicology Pub Date : 2024-11-03 DOI:10.1016/j.fct.2024.115076

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, M Lavelle, I Lee, H Moustakas, J Muldoon, T M Penning, A H Piersma, G Ritacco, N Sadekar, I Schember, T W Schultz, F Siddiqi, I G Sipes, G Sullivan, Y Thakkar

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引用次数: 0

Abstract

The existing information supports the use of this material as described in this safety assessment. 4-(4-Methyl-3-penten-1-yl)-2(5H)-furanone was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data show that 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is not mutagenic. The clastogenicity endpoint was evaluated using the Threshold of Toxicological Concern (TTC) for the genotoxicity endpoint material, and the exposure to 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is below the TTC (0.0025 μg/kg/day). The repeated dose, reproductive, and local respiratory toxicity endpoints were evaluated using the TTC for a Cramer Class III material, and the exposure to 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is below the TTC (0.0015 mg/kg/day, 0.0015 mg/kg/day, and 0.47 mg/day, respectively). The skin sensitization endpoint was completed using the Dermal Sensitization Threshold (DST) for reactive materials (64 μg/cm²); exposure is below the DST. The photoirritation/photoallergenicity endpoints were evaluated based on ultraviolet/visible (UV/Vis) spectra; 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is not expected to be photoirritating/photoallergenic. The environmental endpoints were evaluated; for the hazard assessment based on the screening data, 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone is not Persistent, Bioaccumulative, and Toxic (PBT) as per the International Fragrance Association (IFRA) Environmental Standards. For the risk assessment, 4-(4-methyl-3-penten-1-yl)-2(5H)-furanone was not able to be risk screened as there were no reported volumes of use (VoU) for either North America or Europe in the 2019 IFRA Survey.

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RIFM 香料成分安全评估，4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮，化学文摘社登记号 61315-75-1。

现有资料支持按本安全评估报告所述使用这种材料。对 4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮进行了遗传毒性、重复剂量毒性、生殖毒性、局部呼吸毒性、光刺激/光过敏性、皮肤过敏和环境安全性评估。数据显示，4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮不具有诱变性。对遗传毒性终点的评估采用了遗传毒性终点材料的毒理学关注阈值（TTC），4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮的暴露量低于 TTC（0.0025 微克/千克/天）。重复剂量、生殖毒性和局部呼吸毒性终点采用 Cramer III 类物质的 TTC 进行评估，4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮的暴露量低于 TTC（分别为 0.0015 毫克/千克/天、0.0015 毫克/千克/天和 0.47 毫克/天）。皮肤过敏终点是根据活性物质的皮肤过敏阈值（DST）（64 微克/平方厘米）确定的；暴露量低于 DST。根据紫外线/可见光（UV/Vis）光谱对光刺激性/光过敏性终点进行了评估；预计 4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮不会产生光刺激性/光过敏性。对环境端点进行了评估；根据筛选数据进行危害评估，按照国际芳香协会（IFRA）环境标准，4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮不具有持久性、生物累积性和毒性（PBT）。在风险评估中，由于 2019 年国际芳香协会调查中没有北美或欧洲使用量（VoU）的报告，因此无法对 4-(4-甲基-3-戊烯-1-基)-2(5H)-呋喃酮进行风险筛选。

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.