In a significant move towards reducing reliance on animal studies, the European Chemicals Agency (ECHA) has taken a pioneering step by commissioning a consortium led by the renowned Fraunhofer Institute for Toxicology and Experimental Medicine ITEM. This ambitious collaboration, which also involves key partners such as Michabo Health Science and BASF Metabolome Solutions, is set to explore the potential of new approach methodologies (NAMs) in enhancing the safety assessments of chemical substances.
With a substantial investment of 4.2 million euros over a six-year period, this project is poised to delve into the reliability and relevance of OMICS technologies and toxicokinetics. The primary goal is to garner regulatory acceptance for additional NAMs, thereby minimizing the need for animal testing in the evaluation of chemical safety.
The consortium brings together a diverse array of expertise, including the department for experimental toxicology and ecology at BASF, the University of Birmingham, and biotech innovators BioClavis and Novogene Europe. This collaboration underscores a collective commitment to advancing scientific methods that could revolutionize the way chemical hazards are assessed.
Dr. Sylvia Escher, a leading toxicologist and Head of the Department In-silico Toxicology at Fraunhofer ITEM, highlighted the project's vision:
This project will promote the integration of NAMs such as multi-omic and physiologically based kinetic modelling into hazard assessment, so that eventually animal testing wouldn’t be necessary any longer for every single substance.
One of the innovative strategies under exploration is the "grouping and read-across" approach, which leverages existing toxicity data from structurally similar substances to predict the properties of untested chemicals. This method, already in use under the EU's REACH regulation, represents a key component of the consortium's efforts to fill data gaps and enhance safety assessments without the need for animal testing.
OMICS technologies, central to the consortium's research, offer promising avenues for understanding the effects of chemicals on gene activation (transcriptomics) and metabolic processes (metabolomics). By analysing a wide array of biological changes, these technologies have the potential to provide comprehensive insights into the hazardous impacts of substances, thereby facilitating a more informed regulatory assessment process.
Furthermore, the project aims to refine methods for predicting the kinetic behaviour of substances within organisms, including their absorption, distribution, metabolism, and excretion. The evaluation of physiologically based kinetic (PBK) modelling data is crucial for understanding the performance and limitations of these methods, ultimately contributing to a reduction in animal testing.
This visionary project not only seeks to enhance the accuracy and efficiency of chemical safety assessments but also embodies a significant step towards a more ethical and sustainable scientific landscape, where the welfare of animals is paramount.
