A screening strategy for identifying the developmental and reproductive toxicity potential of botanicals.

CONTEXT: testing and interpretation. There is a need for fit-for-purpose new approach methodologies (NAMs) to evaluate DART hazards of complex mixtures while reducing reliance on mammalian models. OBJECTIVE: This review describes the Botanical Safety Consortium (BSC) DART Working Group strategy to evaluate a battery of NAMs for screening botanical extracts and outlines the botanicals selected as case studies to assess assay suitability for complex mixtures. METHODS: evidence indicating no concern, uncertain effects, or established DART hazards. RESULTS: The selected NAM battery captures diverse mechanisms relevant to DART. The case study botanicals span clear positives (e.g., locoweed, poison hemlock, cottonseed), suspected positives based on limited data (e.g., bitter melon, goldenseal, rue), and low concern examples (e.g., Asian ginseng), enabling evaluation of assay performance for complex mixtures. CONCLUSIONS: This strategy paper lays the groundwork to assess the suitability of integrated NAMs for screening botanical DART potential and establishes the foundation for subsequent testing and case study evaluation.