John Wiley & Sons, Ltd.

A novel framework for interpretation of data from the fish short‐term reproduction assay (FSTRA) for the detection of endocrine‐disrupting chemicals

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The fish short term reproduction assay (FSTRA) is a key component of the USEPA endocrine disruptor screening program (EDSP), which uses a weight‐of‐evidence analysis based on data from several assays to identify the potential for chemicals to act as agonists or antagonists of the estrogen or androgen receptors (ER, AR), or inhibitors of steriodogenic enzymes. The FSTRA considers a variety of mechanistic and apical responses in 21‐d exposures with the fathead minnow (Pimephales promelas), including plasma steroid and vitellogenin (VTG; egg yolk protein) concentrations, secondary sex characteristics (SSC), gonad size and histopathology, and egg production. Although the FSTRA was first described several years ago, recent data generation associated with implementation of the EDSP highlighted the need for more formal guidance as to evaluation of information from the assay. Herein we describe a framework for interpretation of FSTRA data relative to perturbation of endocrine pathways of concern to the EDSP. The framework considers endpoints individually and as suites of physiologically‐related responses relative to pathway identification. Sometimes changes in single endpoints can be highly diagnostic (e.g., induction of VTG in males by ER agonists; production of male SSCs in females by AR agonists), while in other instances multiple, related endpoints are needed to reliably assess pathway perturbation (e.g., AR antagonism; steroid synthesis inhibition). In addition to description of an interpretive framework, we demonstrate its practical utility using publically‐available FSTRA data for a wide range of known and hypothesized endocrine‐disrupting chemicals. Environ Toxicol Chem © 2014 SETAC

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