OpenTox Virtual Conferecne 2021 Sesson 9

Challenges in implementing NAMs (New Approach Methodologies) for Endocrine Disruption characterization of chemicals in the regulatory context

New Approach Methodologies (NAMs) in toxicology represent a paradigm shift compared to the traditional system. NAMs include a new and more efficient system based on non-animal methods that are combined to understand the possible health effects of a chemical. This approach requires expertise in the decision of the best method to apply and for the interpretation of the results. 

ED activity is species-specific and needs a dedicated human-based approach based on the study of the mechanism of action. The animal-based approach has many limitations, due to species-specific differences and problems derived from the nonmonotonic dose-response, but also on the protocol design. The risk for false-negative results is high, but also false-positive results can pose a problem with good substances that are excluded from the market for no reason. 

The application of NAMs in this area could solve many problems, but their application is still limited mainly because there is no incentive for their application. EU Regulations are not open to new approaches and animal tests are often mandatory. The in vitro approach is suggested on a voluntary basis and only to elucidate a mechanism.