ABSTRACT
Recent developments in the field of developmental toxicology have resulted in the proliferation of assays designed to detect agents which may be hazardous to the embryo or fetus. Increasing amounts of data from in vitro and other short-term assays have created the need for a peercompiled and reviewed database of quantitative test results. Such a database would help identify data gaps in the literature, provide a coherent basis for reporting assay results, and potentially form a central repository of test results. If verified results from standard in vivo testing protocols (i.e., FDA Segment II, EPA Developmental Toxicity Test, or ICH 4.1.3) that are the “gold standards” by which any alternate test performance must be judged are included in this database, it would provide the framework to establish the sensitivity, specificity, and accuracy of assays used for hazard identification, and to select assays for monitoring mechanisms relevant to the developmental toxicity of particular classes of compounds. The agreed-upon standard assay
results would enable all developers and users of alternative tests to judge performance against the same information base. At present, assay developers have to either depend upon a list, suggested in the early 1980s by an expert panel1 that has since been criticized as being biased toward cytotoxic agents and for deemphasizing maternal toxicity as a potential confounder, or to assess the literature themselves. These approaches are neither efficient nor reflective of a contemporary consensus of experts.
