天美传媒

Abstract

Developmental toxicity studies are essential for evaluating the potential risks posed by chemical substances to prenatal development and identifying human teratogens. These studies, typically conducted in animal models, assess the effects of exposures during critical stages of gestation on structural and functional outcomes in offspring. Central to these assessments is the concept of exposure margins, which quantify the relationship between adverse effects observed in animal studies and estimated or observed human exposure levels. This review examines the methodologies employed in developmental toxicity testing, emphasizing the importance of exposure margins in extrapolating animal data to human health risks. Case studies illustrate the application of exposure margins in regulatory decision-making, highlighting substances like thalidomide and phthalates where animal studies informed human health protections. Regulatory considerations, including safety factors and risk assessment approaches, are discussed to underscore the role of exposure margins in setting protective guidelines. Future directions in toxicological research aim to enhance predictive capabilities and address challenges in assessing emerging chemicals. Overall, understanding exposure margins in developmental toxicity studies is critical for identifying human teratogens, informing regulatory policies, and safeguarding prenatal health.