CON4EI: EpiOcular™ Eye Irritation Test (EpiOcular™ EIT) for hazard identification and labelling of eye irritating chemicals
CON4EI: EpiOcular™ Eye Irritation Test (EpiOcular™ EIT) for hazard identification and labelling of eye irritating chemicals
复制标题
DOI：
10.1016/j.tiv.2017.07.002
复制
发表时间：
2018-06-01
影响因子：
3.2
通讯作者：
Van Rompay, An R.
中科院分区：
文献类型：
--
作者：
Kandarova, H.;Letasiova, S.;Van Rompay, An R.
急性眼刺激潜力的评估是化学品测试的国际监管要求的一部分。CON 4 EI项目的目的是开发用于眼刺激评估的分层测试策略。采用8种不同的方法测试了一组80种参比化学品（38种液体和42种固体）。本研究的主要目的是评价试验方法的性能，以区分不需要对严重眼损伤/眼刺激进行分类的化学品（无类别）和需要分类和标签的化学品。此外，在体内分类驱动因素方面的预测能力（即，EpiOcular（TM）EIT获得了97%的灵敏度、87%的特异性和95%的准确性，并且还从最初的验证中证实了其优异的再现性（100%）。该测定适用于本项目中检测的所有化学品类别，其性能不限于特定的分类驱动因素。除了现有的二分分类预测模型外，还提出了一种新的Cat 1预测模型。
Assessment of the acute eye irritation potential is part of the international regulatory requirements for testing of chemicals. The objective of the CON4EI project was to develop tiered testing strategies for eye irritation assessment. A set of 80 reference chemicals (38 liquids and 42 solids) was tested with eight different methods. Here, the results obtained with the EpiOcular (TM) Eye Irritation Test (Err), adopted as OECD TG 492, are shown.The primary aim of this study was to evaluate of the performance of the test method to discriminate between chemicals not requiring classification for serious eye damage/eye irritancy (No Category) and chemicals requiring classification and labelling. In addition, the predictive capacity in terms of in vivo drivers of classification (ie. corneal opacity, conjunctival redness and persistence at day 21) was investigated.EpiOcular (TM) EIT achieved a sensitivity of 97%, a specificity of 87% and accuracy of 95% and also confirmed its excellent reproducibility (100%) from the original validation. The assay was applicable to all chemical categories tested in this project and its performance was not limited to the particular driver of the classification. In addition to the existing prediction model for dichotomous categorization, a new prediction model for Cat 1 is suggested.