An important aspect of safety assessment of chemicals (industrial chemicals, agro-chemicals and pharmaceuticals) is determining their potential developmental and reproductive toxicity (DART).  A number of guidelines have outlined a series of separate DART studies, from fertilization through adulthood and in some cases to second generation. The EOGRT study is the most recent and comprehensive guideline in this series. EOGRT study design makes toxicity testing progressive, comprehensive, and efficient by assessing key endpoints across multiple life-stages at relevant doses using minimum number of animals, combining studies/evaluations and proposing tiered testing approaches based on outcomes. EOGRT study determines toxicity during preconception, development of embryo/fetus and newborn, adolescence, and adults with specific emphasis on the nervous, immunological, and endocrine systems. EOGRT study also assesses maternal and paternal toxicity. However, EOGRT study guideline is complex, criteria for selecting doses is unclear, and guidance for monitoring systemic dose during the course of the study for better interpretation and human relevance is vague. This presentation will discuss potential simplification of EOGRT study and suggest procedures for relevant dose selection and monitoring systemic dose at multiple life-stages for better interpretation of the generated data and human relevance.

Use of toxicokinetics to improve the current extended one-generation reproductive toxicity (EOGRT) study design

252nd National Meeting (2016)

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