RIFM Natural Complex Substance (NCS) fragrance ingredient safety assessment, clove bud absolute, CAS Registry Number 8000-34-8, RIFM ID 583-F2.1

IF 3.9 3区医学 Q2 FOOD SCIENCE & TECHNOLOGY

Food and Chemical Toxicology Pub Date : 2025-04-01 DOI:10.1016/j.fct.2025.115415

A.M. Api , A. Bartlett , D. Belsito , D. Botelho , M. Bruze , A. Bryant-Friedrich , G.A. Burton Jr. , M.A. Cancellieri , H. Chon , M.L. Dagli , W. Dekant , C. Deodhar , K. Farrell , A.D. Fryer , L. Jones , K. Joshi , A. Lapczynski , M. Lavelle , I. Lee , H. Moustakas , Y. Tokura

{"title":"RIFM Natural Complex Substance (NCS) fragrance ingredient safety assessment, clove bud absolute, CAS Registry Number 8000-34-8, RIFM ID 583-F2.1","authors":"A.M. Api , A. Bartlett , D. Belsito , D. Botelho , M. Bruze , A. Bryant-Friedrich , G.A. Burton Jr. , M.A. Cancellieri , H. Chon , M.L. Dagli , W. Dekant , C. Deodhar , K. Farrell , A.D. Fryer , L. Jones , K. Joshi , A. Lapczynski , M. Lavelle , I. Lee , H. Moustakas , Y. Tokura","doi":"10.1016/j.fct.2025.115415","DOIUrl":null,"url":null,"abstract":"<div><div>Clove bud absolute was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data for components of the NCS do not show a concern for genotoxicity. Clove bud absolute was evaluated for the repeated dose and reproductive toxicity endpoints on the basis of component analysis using a combination of target data, read-across data, and Threshold of Toxicological Concern (TTC); clove bud absolute is safe for use under the conditions described in this safety assessment for the repeated dose and reproductive toxicity endpoints. Data for components of the NCS do not show a concern for skin sensitization under the current declared levels of use. The photoirritation endpoint was evaluated based on ultraviolet/visible (UV/Vis) absorption spectra for the components of the NCS; clove bud absolute is not expected to be photoirritating. The photoallergenicity endpoint was evaluated based on UV/Vis absorption spectra for the components of the NCS; clove bud absolute is not expected to be photoallergenic. The local respiratory toxicity endpoint for this NCS was evaluated using the inhalation TTC for a Cramer Class III material, and the inhalation exposure to clove bud absolute is below the TTC (0.47 mg/day). Based on the component assessment, clove bud absolute does not contain Persistent, Bioaccumulative, and Toxic (PBT) or (very) Persistent, (very) Bioaccumulative (vPvB) components as per the IFRA Environmental Standards and does not present a risk to the aquatic environment at the current reported VoU.</div></div>","PeriodicalId":317,"journal":{"name":"Food and Chemical Toxicology","volume":"201 ","pages":"Article 115415"},"PeriodicalIF":3.9000,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and Chemical Toxicology","FirstCategoryId":"97","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0278691525001838","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Clove bud absolute was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data for components of the NCS do not show a concern for genotoxicity. Clove bud absolute was evaluated for the repeated dose and reproductive toxicity endpoints on the basis of component analysis using a combination of target data, read-across data, and Threshold of Toxicological Concern (TTC); clove bud absolute is safe for use under the conditions described in this safety assessment for the repeated dose and reproductive toxicity endpoints. Data for components of the NCS do not show a concern for skin sensitization under the current declared levels of use. The photoirritation endpoint was evaluated based on ultraviolet/visible (UV/Vis) absorption spectra for the components of the NCS; clove bud absolute is not expected to be photoirritating. The photoallergenicity endpoint was evaluated based on UV/Vis absorption spectra for the components of the NCS; clove bud absolute is not expected to be photoallergenic. The local respiratory toxicity endpoint for this NCS was evaluated using the inhalation TTC for a Cramer Class III material, and the inhalation exposure to clove bud absolute is below the TTC (0.47 mg/day). Based on the component assessment, clove bud absolute does not contain Persistent, Bioaccumulative, and Toxic (PBT) or (very) Persistent, (very) Bioaccumulative (vPvB) components as per the IFRA Environmental Standards and does not present a risk to the aquatic environment at the current reported VoU.

查看原文本刊更多论文

天然复合物质（NCS）香料成分安全性评价，丁香芽绝对，CAS注册号8000-34-8，RIFM ID 1048330。

对丁香芽的遗传毒性、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。NCS成分的数据没有显示出遗传毒性。利用目标数据、读取数据和毒理学关注阈值（TTC）的组合进行成分分析，评估丁香芽绝对物的重复剂量和生殖毒性终点；在本安全评估中描述的重复剂量和生殖毒性终点条件下，绝对丁香芽是安全的。NCS成分的数据显示，在目前申报的使用水平下，不存在皮肤致敏的问题。根据NCS成分的紫外/可见（UV/Vis）吸收光谱评估光刺激终点；丁香芽绝对不会有光刺激。根据NCS成分的紫外/可见吸收光谱评估光致敏终点；丁香芽绝对不会光致过敏。使用克莱默III类材料的吸入TTC来评估该NCS的局部呼吸毒性终点，吸入丁香芽绝对暴露低于TTC （0.47 mg/天）。根据成分评估，根据IFRA环境标准，丁香芽绝对不含持久性，生物蓄积性和毒性（PBT）或（非常）持久性，（非常）生物蓄积性（vPvB）成分，并且在当前报告的VoU中不会对水生环境构成风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.