Validation in Support of Internationally Harmonised OECD Test Guidelines for Assessing the Safety of Chemicals

Abstract

Ten years elapsed since the OECD published the Guidance document on the validation and international regulatory acceptance of test methods for hazard assessment. Much experience has been gained since then in validation centres, in countries and at the OECD on a variety of test methods that were subjected to validation studies. This chapter reviews validation principles and highlights common features that appear to be important for further regulatory acceptance across studies. Existing OECD-agreed validation principles will most likely generally remain relevant and applicable to address challenges associated with the validation of future test methods. Some adaptations may be needed to take into account the level of technique introduced in test systems, but demonstration of relevance and reliability will continue to play a central role as pre-requisite for the regulatory acceptance. Demonstration of relevance will become more challenging for test methods that form part of a set of predictive tools and methods, and that do not stand alone. OECD is keen on ensuring that while these concepts evolve, countries can continue to rely on valid methods and harmonised approaches for an efficient testing and assessment of chemicals.