Proposed key characteristics of male reproductive toxicants as a method for organizing, screening mechanistic evidence for non-cancer outcomes.
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The adoption of systematic review practices for risk assessment includes integration of evidence obtained from experimental, epidemiological, and mechanistic studies. Although mechanistic evidence plays an important role in mode of action analysis, the process of sorting and analyzing mechanistic studies and outcomes is a challenging exercise due to the diversity of research models and methods, and the variety of known and proposed pathways for chemical-induced toxicity. The recently identified Ten Key Characteristics of Carcinogens provide a valuable tool for organizing chemical-specific data on potential mechanisms of carcinogenesis. However, such an approach has not yet been developed for non-cancer adverse outcomes. Our objective in this study was to identify a set of key characteristics that could be applied for screening mechanistic evidence for male reproductive effects. Identification of eight key characteristics of male reproductive toxicants was based on a survey of known male reproductive toxicants and established mechanisms/pathways of toxicity. The proposed key characteristics provide a useful method that can facilitate the systematic and transparent organization of mechanistic evidence relevant to chemical-induced effects in the male reproductive system. Disclaimer: The views expressed are those of the authors and do not necessarily represent the views or policies of the U.S. EPA.