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  • 文章类型: Guideline
    EpiSkin™皮肤腐蚀测试方法已在OECDTG431的范围内正式验证和采用,用于识别腐蚀性和非腐蚀性化学品。欧盟分类,标签和包装法规(EUCLP)系统要求将腐蚀性化学品细分为联合国GHS可选的三个子类别1A,1B和1C。本研究旨在调查经过验证的EpiSkin™测试方法的有效性,以识别皮肤腐蚀性UNGHS类别1A,图1B和1C使用原始和验证的预测模型和用于直接降低MTT的适应性对照。总的来说,经合组织皮肤腐蚀专家组选择的85种化学品在三个独立运行中进行了测试。与历史数据相比,所获得的结果在实验室内(>80%)和实验室之间(>78%)都具有很高的可重复性。此外,所获得的结果表明,EpiSkin™测试方法在区分腐蚀性和非腐蚀性化学品方面具有高度敏感性(99%)和特异性(80%),并且可以可靠和相关地识别不同的皮肤腐蚀性UNGHS子类别,对于UNGHS类别1A(83%)和1B/1C(76%)化学品都获得了很高的准确性。将腐蚀性化学品分为三个或两个UNGHS子类别的测试方法的总体准确性在75%至79%之间。考虑到这些结果,经修订的OECD测试指南431允许使用EpiSkin™将腐蚀性化学品至少分为两类(1A类和1B/1C类)。
    The EpiSkin™ skin corrosion test method was formally validated and adopted within the context of OECD TG 431 for identifying corrosive and non-corrosive chemicals. The EU Classification, Labelling and Packaging Regulation (EU CLP) system requires the sub-categorisation of corrosive chemicals into the three UN GHS optional subcategories 1A, 1B and 1C. The present study was undertaken to investigate the usefulness of the validated EpiSkin™ test method to identify skin corrosive UN GHS Categories 1A, 1B and 1C using the original and validated prediction model and adapted controls for direct MTT reduction. In total, 85 chemicals selected by the OECD expert group on skin corrosion were tested in three independent runs. The results obtained were highly reproducible both within (>80%) and between (>78%) laboratories when compared with historical data. Moreover the results obtained showed that the EpiSkin™ test method is highly sensitive (99%) and specific (80%) in discriminating corrosive from non-corrosive chemicals and allows reliable and relevant identification of the different skin corrosive UN GHS subcategories, with high accuracies being obtained for both UN GHS Categories 1A (83%) and 1B/1C (76%) chemicals. The overall accuracy of the test method to subcategorise corrosive chemicals into three or two UN GHS subcategories ranged from 75% to 79%. Considering those results, the revised OECD Test Guideline 431 permit the use of EpiSkin™ for subcategorising corrosive chemicals into at least two classes (Category 1A and Category 1B/1C).
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