Key characteristics approach for evidence screening and analysis of benzo[a]pyrene-induced male reproductive toxicity.
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Hazard evaluation of chemical-induced toxicity involves the analysis of toxicological, epidemiological and mechanistic evidence. The eight key characteristics (KCs) of male reproductive toxicants provide a tool for identifying and organizing evidence across mechanistic studies. The goal of this presentation is to provide an overview of a case study using the KCs of male reproductive toxicants to screen, organize, and evaluate mechanistic evidence on benzo[a]pyrene (B[a]P)-induced male reproductive toxicity. A literature search was performed, relevant studies which met pre-defined criteria were screened, and a literature inventory was constructed using the eight KCs of male reproductive toxicants. The 2,172 studies identified were screened using SWIFT-ACTIVE Screener and DistillerSR, resulting in 64 in vitro and in vivo studies that met inclusion criteria. A literature inventory was developed to extract mechanistic and toxicological evidence from the identified studies and to facilitate the review process. Analysis of the available evidence for each KC led to the identification of potential pathways associated with B[a]P-induced male reproductive toxicity at the molecular cellular, organ and organism level. This case study demonstrates that the KCs approach serves as a transparent and efficient tool to identify, organize, and evaluate mechanistic studies, and to facilitate the analysis of biological plausibility and human relevance of the available evidence. Disclaimer: The views expressed are those of the authors and do not necessarily represent the views or policies of the US EPA.