BASF to Develop Alternative to Animal Testing

The purpose of the agreement is to ensure the acceptance of additional NAMs by regulatory authorities by focusing on molecular biological technologies (OMICS and toxicokinetics), thereby further reducing the number of animal studies conducted as part of safety assessments for chemical substances. The agreement will run for six years and will have a total of EUR 4.2 million from the ECHA budget. The contracted research project is being conducted by the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hanover, Germany. ITEM is coordinating the work of Michabo Health Science, based in Coventry, UK, and BASF Metabolome Solutions in Berlin, Germany. Other partners include the experimental toxicology and ecology department of BASF in Ludwigshafen, Germany, the University of Birmingham in the UK, and the biotechnology companies BioClavis based in Glasgow, Scotland, and Novogene Europe in Cambridge, UK. The research partners will support ECHA in developing guidance that can be used to reliably predict the properties of substances for which sufficient safety information is not yet available. The grouping and read-across approach uses existing safety data obtained from structurally similar substances to make these predictions. Hennicke Kamp, Chief Executive Officer and toxicologist at BASF Metabolome Solutions, said: "This approach is already being used to close data gaps in registrations under the EU chemicals regulation REACH. We want to expand this approach further, for example through the use of molecular biological methods. If grouping and read-across are applied correctly, it will no longer be necessary to test each substance on animals. This means we can further reduce the number of animal studies and the costs of safety assessments." One of the main focuses of the research is to address the informative value of OMICS technologies in chemical safety assessments. These technologies can be used, among other activities, to examine gene activation (transcriptomics) in cultured cells or in a living organism, or all metabolic processes (metabolomics). With OMICS technologies, researchers can measure numerous different changes in a biological sample to assess whether substances potentially have a hazardous effect. For example, transcriptomics can determine how gene activities change after exposure to a particular substance. Researchers can then draw conclusions about changes occurring in cells or organs. Metabolomic technologies can be used to examine metabolic products such as amino acids, lipids, or hormones in cells. If these change, the health of an organism can be assessed similar to a diagnostic blood test in a doctor's office. The research team aims to find out under which conditions OMICS technologies can reliably provide relevant and reproducible findings to assess the safety of chemical substances. Regulatory authorities should then be able to refer to these findings when evaluating substances. This could also reduce the number of animal studies needed in the future. Necessary regulatory guidance also needs to be developed. The project will also evaluate methods for predicting how substances are absorbed, distributed, and eliminated in an organism, as well as for assessing substance accumulation and degradation. These methods include computational modelling approaches called physiologically-based kinetic (PBK) models. To facilitate the application and implementation of such PBK modelling data in regulatory toxicology, the consortium will evaluate the applicability of PBK models and input parameters, particularly in silico (computer-based) and in vitro (controlled conditions outside the body on isolated cells, tissues, or organs) toxicokinetic parameters. A particular focus is on better understanding the performance and limitations of these methods and existing information and data gaps. Source