OECD Environment, Health and Safety Publications Series on Testing and Assessment No. 43 DRAFT GUIDANCE DOCUMENT ON REPRODUCTIVE TOXICITY TESTING AND ASSESSMENT Environment Directorate Organisation for Economic Co-operation and Development

The Organisation for Economic Cooperation and Development (OECD) is an intergovernmental organisation in which representatives of 30 industrialised countries in North 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. Purpose of the document 1 0 Definition of developmental/reproductive toxicity and principles of reproductive toxicity hazard assessment 1 1 Identification and assessment of the effects of chemicals on reproduction and development Reproductive toxicity tests 12 Comparative assessment of effects in adult animals 13 Significance of experimental data and their relevance to humans (extrapolation) 13 Single and multi-generation studies 1 4 Prenatal developmental toxicity study, teratology study 15 Developmental neurotoxicity studies, postnatal studies 16 Reproduction/developmental toxicity screening tests 17 Other in vivo toxicity tests 1 7