Abstract
The purpose of this conference was to reevaluate the need for and use of in vitro teratology assays; to examine the validation process for in vitro tests; and to discuss progress in the validation of in vitro teratology screens. Participants enthusiastically supported further development of short-term in vivo and in vitro systems both as prescreens for developmental toxicity and as experimental systems to explore mechanisms of action of toxicants. The group strongly endorsed the development of an updated reference list ("gold standard") of known developmental toxicants and nontoxicants as essential to further progress in developing and validating prescreening efforts. Independently, an expert group should further evaluate the performance characteristics for a validated prescreen. The limits of usefulness of prescreens for product development, regulatory use, and mechanistic investigations need to be clearly defined. Finally, too few in vitro teratology prescreens have been evaluated under multiple-laboratory conditions with common, agreed-upon test agents to draw firm conclusions regarding the merit and reproducibility of in vitro teratology prescreens. There was general agreement regarding the need to move several of the assays further along the validation pathway, at least using a short list of reference compounds.
Full text
PDF
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Kavlock R. J., Greene J. A., Kimmel G. L., Morrissey R. E., Owens E., Rogers J. M., Sadler T. W., Stack H. F., Waters M. D., Welsch F. Activity profiles of developmental toxicity: design considerations and pilot implementation. Teratology. 1991 Feb;43(2):159–185. doi: 10.1002/tera.1420430208. [DOI] [PubMed] [Google Scholar]
- Kimmel G. L., Smith K., Kochhar D. M., Pratt R. M. Overview of In Vitro Teratogenicity Testing: aspects of validation and application to screening. Teratog Carcinog Mutagen. 1982;2(3-4):221–229. doi: 10.1002/1520-6866(1990)2:3/4<221::aid-tcm1770020304>3.0.co;2-7. [DOI] [PubMed] [Google Scholar]
- Schardein J. L., Schwetz B. A., Kenel M. F. Species sensitivities and prediction of teratogenic potential. Environ Health Perspect. 1985 Sep;61:55–67. doi: 10.1289/ehp.856155. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Smith M. K., Kimmel G. L., Kochhar D. M., Shepard T. H., Spielberg S. P., Wilson J. G. A selection of candidate compounds for in vitro teratogenesis test validation. Teratog Carcinog Mutagen. 1983;3(6):461–480. doi: 10.1002/1520-6866(1990)3:6<461::aid-tcm1770030603>3.0.co;2-i. [DOI] [PubMed] [Google Scholar]