Spielmann H, Gerner I, Kalweit S, Moog R, Wirnsberger T, Krauser K, Kreiling R, Kreuzer H, Lüpke N P, Miltenburger H G, Müller N, Mürmann P, Pape W, Siegemund B, Spengler J, Steiling W, Wiebel F J
ZEBET (Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch), Robert v. Ostertag Institut, Germany.
Toxicol In Vitro. 1991;5(5-6):539-42. doi: 10.1016/0887-2333(91)90089-v.
A national interlaboratory study to validate two alternative methods to the Draize rabbit's eye test, co-ordinated by ZEBET at the German Federal Health Office (BGA), is described. The aim of the study is to classify chemicals according to their irritation potential using the neutral red/kenacid blue (NR/KB) cytotoxicity assay and the hen's egg chorioallantoic membrane (HET-CAM) test. During the last two years 12 toxicology laboratories from industry, universities and other research institutions have tested 32 substances from a variety of chemical classes, characterized by a broad spectrum of locally irritating properties, using the NR/KB cytotoxicity test and the HET-CAM assay. Intra- and interlaboratory reproducibility of the two methods was investigated under standardized conditions. The so-far limited evaluation of the interlaboratory assessment phase of validation indicates that the results of the Draize rabbit's eye test correlate better with the results of the HET-CAM test than with those of the cytotoxicity test as far as false negative results are concerned. However, the intra- and interlaboratory reproducibility of the cytoxicity test is better than that of the HET-CAM test. The validation project has recently entered the stage of database development during which 150 chemicals will be tested in seven laboratories to provide information on whether and to what extent the NR/KB test and the HET-CAM test can replace the Draize rabbit's eye test for the classification and labelling of chemicals with regard to their eye irritation potential.
描述了一项由德国联邦卫生局（BGA）的ZEBET协调开展的全国性实验室间研究，该研究旨在验证两种替代兔眼Draize试验的方法。该研究的目的是使用中性红/肯那酸蓝（NR/KB）细胞毒性试验和鸡胚绒毛尿囊膜（HET-CAM）试验，根据化学品的刺激潜力对其进行分类。在过去两年中，来自工业界、大学和其他研究机构的12个毒理学实验室使用NR/KB细胞毒性试验和HET-CAM试验，对32种来自各种化学类别的物质进行了测试，这些物质具有广泛多样的局部刺激特性。在标准化条件下研究了这两种方法在实验室内和实验室间的重现性。到目前为止，对验证的实验室间评估阶段的有限评估表明，就假阴性结果而言，兔眼Draize试验的结果与HET-CAM试验的结果相关性比与细胞毒性试验的结果更好。然而，细胞毒性试验在实验室内和实验室间的重现性优于HET-CAM试验。该验证项目最近进入了数据库开发阶段，在此阶段，将在七个实验室对150种化学品进行测试，以提供关于NR/KB试验和HET-CAM试验是否以及在何种程度上可以替代兔眼Draize试验，用于化学品眼刺激潜力分类和标签的信息。
