Chairs: Elise Grignard & Bambou Tan
The regulatory landscape for endocrine disruptor (ED) assessment is undergoing significant transformation, driven by updated eg. CLP, REACH regulations and the increasing availability of validated New Approach Methodologies (NAMs). While validated NAMs, including QSAR and in vitro binding and transactivation assays, exist, a key challenge remains: interpreting positive results and translating them into robust risk assessments. This session addresses this critical challenge by providing an update on regulatory decision-making for EDs and exploring the state-of-the-art in NAMs for ED assessment (e.g., assays for ER, AR, and the thyroid pathway), their validation status, and the complexities of risk evaluation. Moving beyond simply demonstrating the existence of these tools, we delve into the practical application of existing building blocks—validated NAMs, QSAR models, and in vitro assays—to construct tiered assessment strategies. The session explores decision tree frameworks and Integrated Approaches to Testing and Assessment (IATA) to facilitate data interpretation and risk characterization. This session aims to identify scientific gaps and build confidence in interpreting positive results from one or multiple NAMs, especially concerning identification criteria and effect levels. By promoting international collaboration on NAMs and establishing defined approaches for ED assessment, we can avoid redundancy in development efforts and focus resources on critical gaps, such as assays for other relevant receptors, ensuring efficient resource allocation, accelerating the pace of scientific advancement, and ultimately strengthening regulatory decision-making.
Speakers
- Elise Grignard – OECD WORK ON ENDOCRINE DISRUPTORS
- Matthew Burbank – Endocrine Disruption Testing strategy based on NAMs: from standardized to more predictive in vitro methods
- Bram Brouwer – HAZARD ASSESSMENT OF SUBSTANCES ON THE ENDOCRINE (EATS) – AXES USING HUMAN CELL-BASED CALUX® REPORTER GENE ASSAYS COUPLED TO A METABOLIC MODULE.
- Timo Hamers – NAMs FOR THYROID HORMONE SYSTEM DISRUPTION AND THEIR ROLE IN TESTING STRATEGIES