BASF SE, Product Safety, Ludwigshafen, Germany.
Altern Lab Anim. 2011 Mar;39(1):37-53. doi: 10.1177/026119291103900119.
Data on eye irritation are generally needed for the hazard identification of chemicals. As the Bovine Corneal Opacity and Permeability (BCOP) test has been accepted by many regulatory agencies for the identification of corrosive and severe ocular irritants since September 2009 (OECD Test Guideline 437, TG 437), we evaluated this alternative method for routine testing at BASF. We demonstrated our technical proficiency by testing the reference standards recommended in TG 437, and 21 additional materials with published BCOP and in vivo data. Our results matched the published in vitro data very well, but with some intentionally selected false negatives (FNs) and false positives (FPs), the concordance was 77% (24/31), with FN and FP rates of 20% (2/10) and 24% (5/21), respectively. In addition, we tested 21 in-house materials, demonstrating the utility of the BCOP assay for our own test material panel. Histopathological assessment of the corneas by light microscopy was also conducted, as this was suggested as a means of improving the identification of FNs. The histopathology corrected the classification of some FNs, but also increased the number of FPs. Parallel to the test method evaluation, we compared three new opacitometer models with the current standard device. We recommend the use of an opacitometer developed in our BASF laboratory, which has certified components and electronic data storage, resulting in what we consider to be excellent sensitivity, stability and reproducibility.
有关眼睛刺激的数据通常是化学品危害识别所必需的。自 2009 年 9 月（OECD 测试指南 437，TG 437）以来，牛角膜混浊和通透性（BCOP）试验已被许多监管机构接受，用于识别腐蚀性和严重的眼部刺激性物质，因此我们评估了该替代方法在 BASF 的常规测试中的应用。我们通过测试 TG 437 中推荐的参考标准以及 21 种具有公布的 BCOP 和体内数据的其他材料，证明了我们的技术能力。我们的结果与公布的体外数据非常吻合，但由于一些故意选择的假阴性（FN）和假阳性（FP），一致性为 77%（24/31），FN 和 FP 的比率分别为 20%（2/10）和 24%（5/21）。此外，我们还测试了 21 种内部材料，证明了 BCOP 测定法对我们自己的测试材料的实用性。还通过光学显微镜对角膜进行了组织病理学评估，因为这被建议作为识别 FN 的一种手段。组织病理学纠正了一些 FN 的分类，但也增加了 FP 的数量。与测试方法评估平行，我们比较了三种新型光密度计模型与当前的标准设备。我们建议使用我们 BASF 实验室开发的光密度计，该光密度计具有认证的组件和电子数据存储，这导致我们认为具有出色的灵敏度、稳定性和重现性。
