Report 2025

Replacement of a fish full life cycle study by a weight of evidence analysis addressing regulatory concerns on environmental impact

Regulatory agencies may request fish full life cycle studies to inform whether a compound might have reproductive toxicity at environmentally relevant concentrations. This member company instead conducted a systematic literature review, analyzed the compound’s mechanism of action, reviewed preclinical and clinical reproductive toxicity data, and compared environmental exposure levels to therapeutic plasma concentrations. This evidence demonstrated no mechanistic link to reproductive toxicity in fish, convincing regulators to waive the requested fish life cycle study, thus saving over 600 animals.

Project name: Replacement of Fish Full Life Cycle Study via Weight of Evidence
Charter articles: 1, 8