The term "New Approach Methodologies (NAMs)" encompasses methods for identifying the adverse effects of chemicals without the need for animal testing. This could include computer modelling based on the molecular structure of the substance being assessed (in silico) or tests on cell cultures (in vitro).
"For many adverse effects, animal testing is the only validated assessment method that can be used under the European REACH Regulation (Registration, Evaluation and Authorisation of Chemicals)," explains Thalia de Castelbajac, project leader for PARC in the Methodology and Studies Unit of ANSES's Risk Assessment Department.
The PARC project, coordinated by ANSES, began in 2022 and will run for a period of seven years. Within this partnership, scientists from the "Hazard Assessment" work package , co-led by ANSES and the German Federal Institute for Risk Assessment (BfR), have identified five adverse effects that will be the focus of work during the first phase of the partnership: carcinogenic effects without DNA damage, metabolic disruption, endocrine disruption with a focus on thyroid effects, immunotoxicity, i.e. adverse effects on the immune system, and neurotoxicity.
For each of these adverse effects, the scientists will develop new methodological approaches and conduct case studies, whose results could facilitate acceptance of these methods by regulatory agencies. Work on other hazards will be conducted at a later date.
Closer to the mechanisms of action
"The development of non-animal tests is essential, not only from an ethical point of view, but also to identify the mechanisms of action of substances at cellular or molecular level," explains the scientist.
Another advantage of in silico and in vitro studies is that they save time. For example, it takes two years to obtain results on the carcinogenic effects of a product when testing it on rodents. Alternative methods should enable these results to be achieved more quickly.
This work was reported in a series of articles in a special issue of the journal Frontiers in Toxicology. They aim to provide an overview of the approaches used in PARC and explain how the methods developed will help improve chemical hazard assessment.