LAUSR

The fast evolving technologies, the search for new chemicals and synthesis of substitutes for the existing chemicals, are posing unprecedented challenges on regulatory agencies that have mainly relied on toxicity testing in laboratory animals to ensure safety of humans and the environment from potential exposure to these substances. In response, a new and well-intended trend to reduce, refine and replace animal testing that are both time and resource intensive with animal alternatives called the New Approach Methodologies (NAMs) that are faster, cheaper, sensitive, and mechanisms-based, has been introduced and widely embraced by the scientific community. However, strategies that help identify and prioritize fit-for-purpose NAMs schemes involving test models, toxicity endpoints, and specific assays for the hazard assessment, as well as strategies that enable validation of their scientific relevance for the regulatory acceptance are lagging behind. As a consequence, the regulatory acceptance of NAMs in decision making is far from reality. This presentation will summarise the current status of NAMs in regulatory toxicology and the role of Adverse Outcome Pathways (AOPs) in the design and development of NAMs, with a specific focus on nanotoxicology.