Validation project of alternatives for the Draize eye test.

Abstract

The Federal Health Office (BGA) has started in June 1988 a national interlaboratory study to validate alternatives to the Draize test. It is supported by grants of the Department of Research and Technology (BMFT) of West Germany. The aim of this collaborative study is to validate the classification of chemicals with regard to their irritation potential using the neutral red/kenacid blue (NR/KB) cytotoxicity assay and the hen's egg test-chorioallantoic membrane (HET-CAM) assay, according to Lüpke. Under the current research scheme, which is coordinated by the West German Public Health Office (BGA), 14 toxicology laboratories in the chemical industry, universities, the BGA, and other research institutions are to study 44 substances with a variety of chemical, biochemical, and toxicological characteristics. The validation test is intended to provide comparative data for the development of an alternative routine test scheme. The collaborative study is performed under routine laboratory conditions. The results should allow a decision on whether and to what extent the results of the NR/KB and the HET-CAM assay can replace the Draize test.