Gautheron P, Giroux J, Cottin M, Audegond L, Morilla A, Mayordomo-Blanco L, Tortajada A, Haynes G, Vericat J A, Pirovano R, Gillio Tos E, Hagemann C, Vanparys P, Deknudt G, Jacobs G, Prinsen M, Kalweit S, Spielmann H
MSD-Chibret, Centre de Recherche, BP 134, 63203 Riom, France.
Toxicol In Vitro. 1994 Jun;8(3):381-92. doi: 10.1016/0887-2333(94)90159-7.
A multinational interlaboratory study to investigate the bovine corneal opacity and permeability (BCOP) assay is presented. The aim of this work was to determine the capability and possible limitations of this method to predict ocular irritancy of a large set of chemicals. The assays were carried out in 12 European laboratories with different types of activity. In each of these laboratories 52 substances, with a wide range of structure, physical form and irritant properties, were tested and in vitro scores were compared with those obtained from concurrent rabbit eye (Draize) tests. The technique was easily learned by workers in the participating laboratories, as shown by the fact that there were consistent responses between treated corneas within an individual laboratory. Interlaboratory variability was also very good. It was found that a given laboratory had a 96% chance of classifying irritants or non-irritants similarly to the other laboratories. In addition, it was observed that corneas preserved overnight responded similarly to freshly prepared tissues, thus allowing flexibility for those laboratories where the availability of corneas is limited. Comparisons between in vivo and in vitro data showed that the BCOP data correctly predicted whether a compound would be irritating or non-irritating for 44 of the 52 compounds (84.6%). Specificity and sensitivity were also greater than 84%, and the same number of substances were overestimated as were underestimated (four out of 52). All of the false negatives were solids whereas most of false positives were liquids, indicating that some adjustment in the protocol may be required depending on the physical state of the substance to be tested. All of the substances selected could be evaluated, with no limitation such as colour, insolubility, low or high pH. Given the number of products evaluated and the reproducibility within and among the laboratories involved, the overall results are quite satisfactory and therefore confirm the usefulness of the assay for screening chemicals for ocular irritation.
本文介绍了一项旨在研究牛角膜混浊和通透性（BCOP）试验的跨国实验室间研究。这项工作的目的是确定该方法预测大量化学品眼刺激性的能力和可能存在的局限性。试验在12个具有不同类型业务的欧洲实验室进行。在每个实验室中，对52种结构、物理形态和刺激性各异的物质进行了测试，并将体外评分与同期兔眼（Draize）试验获得的评分进行了比较。参与实验室的工作人员很容易掌握该技术，这体现在单个实验室内处理过的角膜之间反应一致。实验室间的可变性也非常好。发现给定实验室将刺激性物质或非刺激性物质分类与其他实验室相似的概率为96%。此外，观察到过夜保存的角膜与新鲜制备的组织反应相似，因此对于角膜供应有限的实验室来说具有灵活性。体内和体外数据的比较表明，BCOP数据正确预测了52种化合物中的44种（84.6%）是否具有刺激性或无刺激性。特异性和敏感性也均大于84%，被高估和被低估的物质数量相同（52种中有4种）。所有假阴性物质均为固体，而大多数假阳性物质为液体，这表明可能需要根据待测试物质的物理状态对方案进行一些调整。所选的所有物质均可进行评估，不存在颜色、不溶性、低pH或高pH等限制。鉴于所评估产品的数量以及所涉实验室内部和之间的可重复性，总体结果相当令人满意，因此证实了该试验在筛选化学品眼刺激性方面的有用性。
