基于经合组织GL 497中的皮肤敏感化定义方法的异硫胺化合物的功效分类
Hyejin Kim1,2, Juyoung Park1, Handule Lee1
1College of Pharmacy, Dongduk Women's University, Seoul, Republic of Korea.
Environmental analysis, health and toxicology
|February 1, 2024
概括
使用in chemico,in vitro和in silico数据的定义方法预测了对异二醇的皮肤敏感性危害. 这与监管转向非动物试验方法的调整一致,与体内结果有很好的一致性.
科学领域:
- 毒理学 毒理学 毒理学
- 化学安全评估 化学安全评估
背景情况:
- 对于皮肤敏感化的监管决策越来越依赖于不良结果途径 (AOP) 和综合测试和评估方法 (IATA).
- 经济合作与发展组织 (OECD) 的指导方针现在包含了用于皮肤敏感化的定义方法 (DA),使用固定的数据解释程序 (DIP).
- 定义的方法结合了in chemico,in vitro和in silico数据来预测皮肤敏感化潜力,旨在与动物试验相等.
研究的目的:
- 通过使用定义的方法,评估11种异硫胺化合物的皮肤敏感化潜力.
- 应用经合组织的固定数据解释程序 (DIP) 进行危险识别和强度分类.
- 将定义方法的预测能力与现有的体内试验数据进行比较.
主要方法:
- 利用了直接反应性试验 (DPRA),人类细胞系激活 (h-CLAT) 试验和定量结构活性关系 (QSAR) 工具箱的数据.
- 将固定数据解释程序 (DIP) 应用于收集的数据进行分类.
- 评估了11种异硫胺化合物,包括DCOIT,OIT,MIT,BIT,CMIT/MIT混合物等具体例子.
主要成果:
- 六种异黄胺化合物被归类为联合国GHS 1A (高危).
- 一种化合物被归类为联合国GHS 1 (中等危险).
- 由于数据不足,四种化合物无法被分类,结果通常与体内试验一致.
结论:
- 定义的方法提供了一种可靠的方法来评估isothiazolinones的皮肤敏感性.
- 评估的方法和DIP成功地根据联合国GHS标准分类了几种异硫醇.
- 这些发现支持使用DA作为一种可行的替代品,用于皮肤敏感性评估的动物试验.
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