Guidance Document 117 on the Current Implementation of Internal Triggers in Test Guideline 443 for an Extended One Generation Reproductive Toxicity Study, in the United States and Canada

This document constitutes an essential supplement to OECD Test Guideline 443 (EOGRTS) to describe the use of data gathered within the study to determine if a second generation should be produced. However, as a starting point, available mode of action information and data from other toxicity studies (e.g., repeat dose toxicity studies for systemic toxicity, and ADME) should be considered in the assessment as they may already indicate the potential for reproductive toxicity. The EOGRTS design includes evaluations of numerous sensitive structural, functional, and endocrine-mediated components.