The European Chemicals Agency (ECHA) has tasked a consortium with studying the reliability and relevance of New Approach Methodologies (NAMs) as alternatives to animal testing, aiming to promote their use in the future. These methods include in vitro (laboratory-based experiments using cells or tissues), in silico (computer-based modeling and simulations), and chemistry-based approaches, as well as their implementation strategies. The focus of the consortium is on molecular biological technologies (OMICS and toxicokinetics). The six-year contract, funded by ECHA with €4.2 million, aims to facilitate the acceptance of additional NAMs by regulatory authorities.

The contract research project is led by the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hanover, Germany. Coordinating partners include Michabo Health Science, Coventry, UK, and BASF Metabolome Solutions, Berlin, Germany. Other partners are the Department of Experimental Toxicology and Ecology at BASF, Ludwigshafen, Germany, the University of Birmingham, UK, and the biotech companies BioClavis, Glasgow, Scotland, and Novogene Europe, Cambridge, UK.

The consortium will, for example, evaluate methods for predicting the toxicokinetic behavior of substances in an organism, including their uptake, distribution, excretion, accumulation, and degradation. This includes the application of computer-based models, so-called physiologically based kinetic models (PBK). The aim is to improve the application of these models in regulatory toxicology by evaluating their applicability and parameters, identifying knowledge gaps, and improve method performance.

• BASF SE, Ludwigshafen, Germany
• European Chemicals Agency (ECHA), Helsinki, Finland