Regulatory practices on the genotoxicity testing of nanomaterials and outlook for the future

Abstract

The toxicity of nanomaterials(NMs) is closely tied to their physicochemical properties, such as size, shape, surface chemistry, stability in biological medium, and state of agglomeration as well to their uptake by cells. Key deficiencies in standardized testing approaches have been identified and tackled in recent years. Within the landscape of new approach methods (NAMs), the aim of this work is to review existing approaches for genotoxicity testing of the NMs under different regulatory domains, with a perspective on the development of NAMs that can solve longstanding difficulties in NMs’ risk assessment. It critically examines international and European Union guidelines, highlighting the need for harmonization and the potential of NAMs to drive next-generation risk assessment. However, further collaboration, research and validation are essential to gain wider acceptance and applicability. The contribution of innovative technological approaches based on big data, artificial intelligence and machine learning, may pave powerful comparisons among different sectors and grouping strategies that will furtherance innovation in the nanotoxicology research. The future outlook for the genotoxicity testing of NMs will depend on increased cooperation between regulatory agencies, researchers, and industry stakeholders. Key steps toward overcoming current obstacles include establishing clearer pathways for data sharing, standardizing testing protocols, and fostering greater international collaboration.