Short‐term developmental toxicity testing: Considerations in the validation process

Abstract

The development and validation of short-term tests that assess developmental toxicity have received increased attention due to the large number of agents that need to be tested and the desirability to reduce the overall use of animals in research and safety evaluation. The Short-Term In Vivo Reproductive Toxicity Test was developed to help meet this need and to provide a method for prioritizing agents for further testing. This report provides a brief overview of the risk assessment process and a focus on the aspects of test validation that should be considered when evaluating short-term tests. It is intended to give the reader an appreciation for many of the considerations that must go into developing and validating a short-term test, and to indicate areas within the risk assessment process where inclusion of such a test may be appropriate.

Application of the preliminary developmental toxicity screen for chemical hazard identification under the toxic substances control act

“…As mentioned in EPA's "Proposed Guidelines for the Health Assessment of Suspected Developmental Toxicants" [36], the process of assessing the risk of human developmental toxicity may be adapted to this format. The components of risk assessment are discussed in detail elsewhere in this issue [37]. Briefly, hazard identification is the qualitative risk assessment in which all available data are used to determine if a chemical is likely to elicit developmental toxicity.…”