Use and Acceptance of AOPs for Regulatory Applications

Abstract

Adverse Outcome Pathways (AOPs) play an increasingly important role in risk and hazard assessment, giving scientists across many disciplines and organisations the opportunity to jointly collect and discuss their knowledge about the biological and toxicological processes leading to an Adverse Outcome. While this knowledge becomes more distributed and accepted by the scientific mainstream, its acceptance in a regulatory context is still not well developed. A promising avenue for increasing visibility and applicability of AOPs in the regulatory context is the role they play in the development of Integrated Approaches to Testing and Assessment (IATA), where the mechanistic knowledge AOPs provide will underpin testing strategies accepted by regulators and relying less and less on animal testing. The development of a standardised exchange format for AOPs (AOP-XML) and of an OECD-endorsed regulatory reporting format for results of non-classical test methods (OHT 201) are further enabling factors for any upcoming adoption of AOPs in the regulatory world.