VITO NV (Flemish Institute for Technological Research), Mol, Belgium.
Envigo, Cambridgeshire, United Kingdom.
Toxicol In Vitro. 2018 Jun;49:53-64. doi: 10.1016/j.tiv.2018.03.005. Epub 2018 Mar 27.
Assessment of ocular irritation potential is an international regulatory requirement in the safety evaluation of industrial and consumer products. None in vitro ocular irritation assays are capable of fully categorizing chemicals as stand-alone. Therefore, the CEFIC-LRI-AIMT6-VITO CON4EI consortium assessed the reliability of eight in vitro test methods and computational models as well as established a tiered-testing strategy. One of the selected assays was Bovine Corneal Opacity and Permeability (BCOP). In this project, the same corneas were used for measurement of opacity using the OP-KIT, the Laser Light-Based Opacitometer (LLBO) and for histopathological analysis. The results show that the accuracy of the BCOP OP-KIT in identifying Cat 1 chemicals was 73.8% while the accuracy was 86.3% for No Cat chemicals. BCOP OP-KIT false negative results were often related to an in vivo classification driven by conjunctival effects only. For the BCOP LLBO, the accuracy in identifying Cat 1 chemicals was 74.4% versus 88.8% for No Cat chemicals. The BCOP LLBO seems very promising for the identification of No Cat liquids but less so for the identification of solids. Histopathology as an additional endpoint to the BCOP test method does not reduce the false negative rate substantially for in vivo Cat 1 chemicals.
眼刺激性评估是工业和消费品安全评价的国际监管要求。没有一种体外眼刺激性检测能够完全将化学品归类为单一类别。因此，CEFIC-LRI-AIMT6-VITO CON4EI 联合体评估了八种体外检测方法和计算模型的可靠性，并建立了分级测试策略。所选的检测方法之一是牛眼角膜混浊和通透性（BCOP）。在这个项目中，相同的角膜用于使用 OP-KIT、激光光基于混浊计（LLBO）和组织病理学分析来测量混浊度。结果表明，BCOP OP-KIT 识别 1 类化学品的准确性为 73.8%，而识别无 1 类化学品的准确性为 86.3%。BCOP OP-KIT 的假阴性结果通常与仅由结膜效应驱动的体内分类有关。对于 BCOP LLBO，识别 1 类化学品的准确性为 74.4%，而识别无 1 类化学品的准确性为 88.8%。BCOP LLBO 似乎非常有希望用于识别无 1 类液体，但识别固体的效果则不太理想。组织病理学作为 BCOP 检测方法的附加终点，并不能显著降低体内 1 类化学品的假阴性率。
