Bio: I received a Ph.D. in Veterinary Pharmacology/Toxicology from Kyungpook National University, South Korea and am a Senior Researcher at the Korea Institute of Toxicology. My research focuses on developmental and reproductive toxicity (DART) assessment of chemicals and mixtures, and developing New Approach Methodologies for DART. My work appears in Archives of Toxicology (2024). I am a member of the International Liaison Group on Methods for Risk Assessment of Chemicals in Food and Feed (ILMERAC).
Abstract: Chemical exposures to pregnant women can cause irreversible structural and functional abnormalities in the developing fetus, requiring rigorous developmental and reproductive toxicity (DART) assessments. As the toxicity assessment paradigm shifts from in vivo to New Approach Methodologies (NAMs), the development of NAMs for DART is recognized as one of the most challenging areas. In particular, overcoming the technical limitations of implementing spatiotemporal developmental processes in vitro/in silico and achieving the reliability required by regulatory agencies are key challenges. In this study, we developed a 384-ultra-low attachment well-based embryoid body test (EBT) that enables high-throughput chemical screening for embryotoxicity in 72 hours. The differentiation trajectory to cardiac mesoderm identified by RNAseq analysis supports the biological validity of the system. In compliance with OECD GD 34, the EBT established an 84.38% predictive accuracy and optimized cut-off threshold (750 μM) with reference compounds suggested in the ICH S5(R3) guideline. In particular, the model identified areas of application for the mechanism of action classification of reference substances, improving the reliability and relevance of screening. The EBT is expected to be efficiently integrated into the regulatory evaluation system through further validation in the future.
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Date | Time | Local Time | Room | Forum | Session | Role | Topic |
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2025-10-17 | 17:15-17:30 | 2025-10-17,17:15-17:30 | Room 6 - Guoxing Hall | Symposium Program (Session) |
Session 26: Next Generation Risk Assessment |
Speaker | Improving the EST for NGRA of DART substances |