CON4EI: Development of testing strategies for hazard identification and labelling for serious eye damage and eye irritation of chemicals
CON4EI: Development of testing strategies for hazard identification and labelling for serious eye damage and eye irritation of chemicals
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DOI：
10.1016/j.tiv.2017.09.008
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发表时间：
2018-06-01
影响因子：
3.2
通讯作者：
Van Rompay, A. R.
中科院分区：
文献类型：
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作者：
Adriaens, E.;Verstraelen, S.;Van Rompay, A. R.
急性眼刺激可能性的评估是化学品安全测试国际监管要求的一部分。在过去的几十年中，已经做出了许多努力来寻找替代方法，以取代监管的体内Draize兔眼试验（OECD TG 405）。尚未成功完全取代体内Draize兔眼试验。CEFIC-LRI-AIMT 6-VITO CON 4 EI（体外眼刺激试验策略的CONCLUSION）项目的主要目的是开发用于严重眼损伤和眼刺激评估的分层试验策略，从而完全替代OECD TG 405。一组80种参考化学品（例如，通过分类和物理状态的重要驱动因素进行平衡）采用七种测试方法进行测试。根据该项目的结果，提出了三种不同的策略。我们提供了一个独立的（EpiOcular ET-50），一个两层和三层的策略，可用于区分1类和2类化学品和不需要分类的化学品（无类别）。两层和三层策略在底部使用RhCE测试方法（EpiOcular EIT或SkinEthic（TM）EIT）（标识No Cat），在顶部结合BCOP LLBO（两层策略）或BCOP OP-KIT和SMI（三层策略）（标识Cat 1）。对于我们提出的策略，71.1% 82.9% Cat 1，64.2% 68.5% Cat 2和>= 80%无Cat化学品被正确识别。此外，自上而下和自下而上的方法也得到了类似的结果。
Assessment of acute eye irritation potential is part of the international regulatory requirements for safety testing of chemicals. In the last decades, many efforts have been made in the search for alternative methods to replace the regulatory in vivo Draize rabbit eye test (OECD TG 405). Success in terms of complete replacement of the regulatory in vivo Draize rabbit eye test has not yet been achieved. The main objective of the CEFIC-LRI-AIMT6-VITO CON4EI (CONsortium for in vitro Eye Irritation testing strategy) project was to develop tiered testing strategies for serious eye damage and eye irritation assessment that can lead to complete replacement of OECD TG 405. A set of 80 reference chemicals (e.g. balanced by important driver of classification and physical state), was tested with seven test methods. Based on the results of this project, three different strategies were suggested. We have provided a standalone (EpiOcular ET-50), a two-tiered and three-tiered strategy, that can be used to distinguish between Cat 1 and Cat 2 chemicals and chemicals that do not require classification (No Cat). The two-tiered and three-tiered strategies use an RhCE test method (EpiOcular EIT or SkinEthic (TM) EIT) at the bottom (identification No Cat) in combination with the BCOP LLBO (two-tiered strategy) or BCOP OP-KIT and SMI (three-tiered strategy) at the top (identification Cat 1). For our proposed strategies, 71.1% 82.9% Cat 1, 64.2% 68.5% Cat 2 and >= 80% No Cat chemicals were correctly identified. Also, similar results were obtained for the Top-Down and Bottom-Up approach.