Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways

JT03338300 Complete document available on OLIS in its original format This document and any map included herein are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area. ABOUT THE OECD The Organisation for Economic Cooperation and Development (OECD) is an intergovernmental organisation in which representatives of 34 industrialised countries in North and South America, Europe and the Asia and Pacific region, as well as the European Commission, meet to coordinate and harmonise policies, discuss issues of mutual concern, and work together to respond to international problems. Most of the OECD's work is carried out by more than 200 specialised committees and working groups composed of member country delegates. Observers from several countries with special status at the OECD, and from interested international organisations, attend many of the OECD's workshops and other meetings. Committees and working groups are served by the OECD Secretariat, located in Paris, France, which is organised into directorates and divisions. This publication was developed in the IOMC context. The contents do not necessarily reflect the views or stated policies of individual IOMC Participating Organizations. The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) was established in 1995 following recommendations made by the 1992 UN Conference on Environment and Development to strengthen cooperation and increase international coordination in the field of chemical safety. The purpose of the IOMC is to promote coordination of the policies and activities pursued by the Participating Organisations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment. ENV/JM/MONO(2013)6 6 FOREWORD The Adverse Outcome Pathway (AOP) methodology is an approach which provides a framework to collect, organise and evaluate relevant information on chemical, biological and toxicological effect of chemicals. This approach supports the use of a mode (and/or mechanism) of action basis for understanding adverse effects of chemicals. This guidance document intends to provide an insight into which pieces of information are necessary to identify and document an AOP and how to present them. It also provides initial assistance on how to undertake the assessment of an AOP in terms of its relevance and adequacy. A template has been included allowing authors to develop thorough AOPs and to improve consistency in AOPs developed by different stakeholders. The document also briefly outlines the potential use for …