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首页> 外文期刊>Alternatives to laboratory animals: ATLA >The EpiOcular (TM) Eye Irritation Test is the Method of Choice for the In Vitro Eye Irritation Testing of Agrochemical Formulations: Correlation Analysis of EpiOcular Eye Irritation Test and BCOP Test Data According to the UN GHS, US EPA and Brazil ANVISA Classification Schemes
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The EpiOcular (TM) Eye Irritation Test is the Method of Choice for the In Vitro Eye Irritation Testing of Agrochemical Formulations: Correlation Analysis of EpiOcular Eye Irritation Test and BCOP Test Data According to the UN GHS, US EPA and Brazil ANVISA Classification Schemes

机译：EpiOcular（TM）眼刺激性试验是农用化学品配方的体外眼刺激性试验的选择方法：根据UN GHS，US EPA和巴西ANVISA分类方案对Epiocular眼刺激性试验和BCOP试验数据进行相关分析

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The Bovine Corneal Opacity and Permeability (BCOP) test is commonly used for the identification of severe ocular irritants (GHS Category 1), but it is not recommended for the identification of ocular irritants (GHS Category 2). The incorporation of human reconstructed tissue model-based tests into a tiered test strategy to identify ocular non-irritants and replace the Draize rabbit eye irritation test has been suggested (OECD TG 405). The value of the EpiOcular (TM) Eye Irritation Test (EIT) for the prediction of ocular non-irritants (GHS No Category) has been demonstrated, and an OECD Test Guideline (TG) was drafted in 2014. The purpose of this study was to evaluate whether the BCOP test, in conjunction with corneal histopathology (as suggested for the evaluation of the depth of the injury) and/or the EpiOcular-EIT, could be used to predict the eye irritation potential of agrochemical formulations according to the UN GHS, US EPA and Brazil ANVISA classification schemes. We have assessed opacity, permeability and histopathology in the BCOP assay, and relative tissue viability in the EpiOcular-EIT, for 97 agrochemical formulations with available in vivo eye irritation data. By using the OECD TG 437 protocol for liquids, the BCOP test did not result in sufficient correct predictions of severe ocular irritants for any of the three classification schemes. The lack of sensitivity could be improved somewhat by the inclusion of corneal histopathology, but the relative viability in the EpiOcular-EIT clearly outperformed the BCOP test for all three classification schemes. The predictive capacity of the EpiOcular-EIT for ocular non-irritants (UN GHS No Category) for the 97 agrochemical formulations tested (91% sensitivity, 72% specificity and 82% accuracy for UN GHS classification) was comparable to that obtained in the formal validation exercise underlying the OECD draft TG. We therefore conclude that the EpiOcular-EIT is currently the best in vitro method for the prediction of the eye irritation potential of liquid agrochemical formulations.
机译：牛角膜不透明度和渗透性（BCOP）测试通常用于鉴定严重的眼刺激物（GHS类别1），但不建议用于鉴定眼刺激物（GHS类别2）。有人建议将基于人类重建组织模型的测试合并到分层测试策略中，以识别眼睛无刺激性并替代Draize兔眼刺激性测试（OECD TG 405）。 EpiOcular（TM）眼刺激试验（EIT）对预测眼部非刺激性物质（GHS否类别）的价值已得到证明，并在2014年起草了OECD测试指南（TG）。评估BCOP测试，结合角膜组织病理学（建议用于评估损伤深度）和/或EpiOcular-EIT，是否可以根据UN GHS预测农用化学制剂的眼睛刺激潜力，美国EPA和巴西ANVISA分类方案。我们对97种农用化学制剂进行了BCOP分析，评估了不透明性，通透性和组织病理学，并在EpiCOPY-EIT中评估了相对组织生存力，并获得了体内对眼睛的刺激性数据。通过对液体使用OECD TG 437协议，对于三种分类方案中的任何一种，BCOP测试都无法对严重的眼刺激物做出足够的正确预测。通过包括角膜组织病理学可以改善敏感性的缺乏，但是对于所有三种分类方案，EpiOcular-EIT的相对生存力明显优于BCOP测试。 EpiOcular-EIT对眼睛无刺激物（联合国GHS类别）对97种农用化学品制剂的预测能力（对于联合国GHS分类，灵敏度为91％，特异性为72％，准确度为82％）与正式形式相当。经合组织TG草案的验证工作。因此，我们得出结论，EpiOcular-EIT是目前预测液态农用化学制剂眼刺激潜力的最佳体外方法。

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