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An Update on the Progress of the Extended One-Generation Reproductive Protocol
Citation:
Cooper, R. L. An Update on the Progress of the Extended One-Generation Reproductive Protocol. Presented at Toxicology and Risk Assessment, West Chester, OH, April 14 - 17, 2008.
Impact/Purpose:
Presentation
Description:
Consistent with a more science-based approach assessing potential adverse effects of pesticides, the ILSI-HESI Agricultural Chemical Safety Assessment (ACSA) Technical Committee, proposed a new tiered toxicity testing strategy. This approach utilizes fewer animals and provides an improved basis for the risk assessment of agricultural chemicals (Crit. Rev. Tox, 3,, 69-98, 2006). Although developed for pesticides, this scheme is applicable to other types of environmental chemicals. The ACSA tiered approach considers all existing data for the chemical, (e.g., use pattern and estimated exposures) prior to execution and modifies it accordingly. The guiding principle is to identify areas concern early in testing and thus concentrate on a more detailed evaluation of them. Included in the ACSA tiered approach is a life stage study referred to as the “Extended One-Generation Reproductive Study” (Cooper et al., 2006). Although this protocol incorporates many features of EPA’s and OECD’s current 2-generation reproductive test guidelines, it represents several critical improvements, including (1) use of a toxicokinetic data of pregnant animals/offspring. (2) measurement of systemic toxicity in young adults treated pre- and early postnatally, (3) assessment of multiple outcomes from the same population of animals including sensitive endpoints for endocrine effects, developmental neurotoxicity, and developmental immunotoxicity and (4) mating of F1 offspring to produce an F2 only if the data indicate (i.e., triggered F2), This presentation provides an overview of the extended one-generation protocol and summarizes the progress made in implementing this effort within the US and OECD.