Results of the first phase of the ECVAM project "prevalidation and validation of three in vitro embryotoxicity tests".

The results of the experimental prevalidation of three in vitro embryotoxicity tests in an ECVAM study are reported: the rat whole embryo culture assay (WEC), the micromass assay (MM) and the embryonic stem cell test (EST). Three test chemicals assigned to the three classes of embryotoxicity, non-, moderate- and strong embryotoxic, and also a positive and a negative control chemical were repeatedly tested in each test in two laboratories. The data obtained were evaluated independently by a biostatistician. It could be shown that the standard protocols (SOPs) for the three in vitro embryotoxicity tests could be transferred to a second laboratory and that reproducible results were obtained. The three methods were able to discriminate the test chemicals according to their embryotoxic potential. In addition, within the scope of this study, a test chemical database for in vitro embryotoxicity testing was established that will be used in the following formal validation of the three in vitro tests.