天然复合物质（NCS）香料成分安全性评价，安息香注射液，苏门答腊，CAS注册号9000-05-9，RIFM ID 104-K2.31。

IF 3.5 3区医学 Q2 FOOD SCIENCE & TECHNOLOGY

Food and Chemical Toxicology Pub Date : 2025-10-03 DOI:10.1016/j.fct.2025.115774

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

摘要

本研究评估了苏门答腊安息香注射液的遗传毒性、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。NCS成分的数据没有显示出遗传毒性。在使用靶标数据、读取数据和毒理学关注阈值（TTC）的组合进行成分分析的基础上，评估了苏门答腊安息香输注的重复剂量和生殖毒性终点；在本安全性评估中描述的重复剂量和生殖毒性终点条件下，苏门答腊苯甲酸输注是安全的。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。根据数据和NCS成分的紫外/可见（UV/Vis）吸收光谱评估光刺激终点；苯甲酸乙酯输注，苏门答腊预计不会有光刺激。由于缺乏合适的数据并在体外试验中得到验证，尚未对苏门答腊的安息香输注进行充分的光致敏性评估。为了解决这一数据缺口，RIFM正在赞助一项体外光过敏研究计划，以评估苯甲酸乙酯输注在苏门答腊的光过敏潜力。该NCS的局部呼吸毒性终点使用Cramer III类材料的吸入TTC进行评估，并且吸入接触苯甲酰输注，苏门答腊低于TTC （0.47 mg/天）。根据成分评估，根据IFRA环境标准，benzoin输注，Sumatra不含有持久性，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。此外，根据RIFM环境框架和基于单个成分评估，苯甲酰输注，苏门答腊岛不会对水生环境构成风险（即其筛选水平PEC/PNEC）

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RIFM Natural Complex Substance (NCS) fragrance ingredient safety assessment, benzoin infusion, Sumatra, CAS Registry Number 9000-05-9, RIFM ID 104-K2.31.

Benzoin infusion, Sumatra was evaluated for genotoxicity, repeated dose toxicity, reproductive toxicity, local respiratory toxicity, photoirritation/photoallergenicity, skin sensitization, and environmental safety. Data for the components of the NCS do not show a concern for genotoxicity. Benzoin infusion, Sumatra 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 the threshold of toxicological concern (TTC); benzoin infusion, Sumatra is safe for use under the conditions described in this safety assessment for the repeated dose and reproductive toxicity endpoints. Data for the 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 data and ultraviolet/visible (UV/Vis) absorption spectra for the components of the NCS; benzoin infusion, Sumatra is not expected to be photoirritating. Benzoin infusion, Sumatra has not been fully evaluated for photoallergenicity due to a lack of suitable data and validated in vitro tests. To address this data gap, RIFM is sponsoring an in vitro photoallergy research program to evaluate the photoallergy potential of benzoin infusion, Sumatra. 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 benzoin infusion, Sumatra is below the TTC (0.47 mg/day). Based on the component assessment, benzoin infusion, Sumatra does not contain Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent, very Bioaccumulative (vPvB) components as per the IFRA Environmental Standards. In addition, following the RIFM Environmental Framework and based on individual component assessment, benzoin infusion, Sumatra does not present a risk to the aquatic environment (i.e., its screening-level PEC/PNEC <1) at the current reported VoU.

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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.