根据联合国GHS的三个类别,开发一种明确的方法来识别固体化学品对眼睛的危害
Nathalie Alépée1, Els Adriaens2
1L'Oréal Research & Innovation, Aulnay sous Bois, France.
ALTEX
|May 18, 2024
概括
开发了一种新的固体定义方法 (DAS) 来识别眼睛危害,符合经合组织的绩效标准. 这种方法准确地预测了固体化学品的联合国GHS类别,改善了安全评估.
科学领域:
- 毒理学和化学安全
- 在体外试验方法的测试方法
- 监管科学 监管科学
背景情况:
- 目前经合组织定义的方法 (DA) 主要针对非表面活性剂液体的眼睛危害识别.
- 需要对固体化学品进行验证的DA,以符合联合国GHS的三个类别 (类别1,类别2,无类别).
研究的目的:
- 开发和验证固体定义方法 (DAS),用于确定固体化学品对眼睛的危害.
- 确保DAS符合经合组织确立的准确预测联合国GHS类别的绩效标准.
主要方法:
- 该DAS集成了两种体外试验方法:SkinEthicTM HCE表皮模型 (EIT) 试验 (OECD TG 492) 和牛角膜透明度和透性 (BCOP) 试验 (OECD TG 437).
- 对固体数据库的统计分析,包括体外和体内Draize眼睛测试数据的历史数据,为DAS的发展提供了信息.
- 性能评估涉及将DAS预测与体内Draize眼睛测试分类和经合组织专家组标准进行比较.
主要成果:
- 根据Draize眼睛测试数据,DAS正确识别了77.4%的类别1的固体,52.3%的类别2的固体和70.0%的无类别固体.
- 预测准确度达到或超过了经合组织最低绩效值:75%的类别1,50%的类别2和70%的无类别.
- 错误预测率低于经合组织专家组确定的最高值.
结论:
- 开发的固体定义方法 (DAS) 是一种可靠的方法,用于确定固体化学品对眼睛的危害.
- DAS成功地满足了经合组织设定的性能标准,使其能够被纳入经合组织TG 467.
- 这一进步为分类固体物质对眼睛的危害潜力提供了一个重要的体外替代品.
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