INTERLABORATORY ASSESSMENT OF THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) ASSAY
INTERLABORATORY ASSESSMENT OF THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) ASSAY
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DOI：
10.1016/0887-2333(94)90159-7
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发表时间：
1994-06-01
影响因子：
3.2
通讯作者：
SPIELMANN, H
中科院分区：
文献类型：
--
作者：
GAUTHERON, P;GIROUX, J;SPIELMANN, H
一个跨国实验室间的研究，以调查牛角膜混浊和渗透性（BCOP）测定提出。这项工作的目的是确定这种方法的能力和可能的局限性，以预测大量化学物质的眼睛刺激性。这些化验是在12个具有不同类型活性的欧洲实验室进行的。在这些实验室中，每个实验室测试了52种具有广泛结构、物理形态和刺激性特性的物质，并将其体外得分与同时进行的兔眼（Draize）测试所得的得分进行了比较。这项技术很容易被参与实验室的工作人员学习，正如在个体内治疗的角膜之间有一致的反应这一事实所表明的那样。实验室。实验室间的可变性也很好。结果发现，一个实验室对刺激物或非刺激物进行分类的几率为96%，与其他实验室相似。此外，观察到隔夜保存的角膜与新鲜制备的组织反应相似，从而为角膜可用性有限的实验室提供灵活性。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%）化合物是否具有刺激性。特异性和敏感性也大于84%，高估和低估的物质数量相同（52个中有4个）。所有假阴性都是固体，而大多数假阳性都是液体，这表明可能需要根据待测物质的物理状态对方案进行一些调整。所有选择的物质都可以进行评估，没有诸如颜色，不溶性，低或高ph值等限制。考虑到评估产品的数量以及在所涉及的实验室内部和实验室之间的可重复性，总体结果相当令人满意，因此确认了该测定法用于筛选化学物质对眼睛的刺激的有效性。
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.