A Modular Approach to the Extended One-generation ReproductionToxicity Study The Outcome of an ECETOC Task Force and International ECETOC/ECVAM Workshop

Abstract

This is the report of a combined initiative between the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) and the European Centre for the validation of Alternative Methods (ECVAM) to evaluate triggers and waivers for an extended one-generation reproductive toxicity study, which is being developed as a test guideline by the Organisation for Economic Cooperation and Development (OECD). The initial phase of the work was to review the endpoints evaluated in current regulatory guidelines for developmental and reproductive toxicity and those in newly published proposals for the evaluation of agrochemicals. In particular, it was to design an intelligent testing strategy for reproductive and developmental endpoints, which is suitable for the evaluation of general industrial chemicals and to propose triggers and waivers for the investigation of optional modules in an extended one-generation reproduction study. An additional aim was to describe the extent to which these trigger and waiving criteria can already be considered validated and to propose additional validation steps if needed. The conclusions of the task force were published as ECETOC Document No. 45 (¿1), which served as the basis for a multi-stakeholder workshop organised by ECETOC and ECVAM, and which took place on 14-15 April 2008, at Barza d¿Ispra, Italy. Workshop participants were drawn from academia, the regulatory community, industry, and contract research organisations. The outcome of the discussions and recommendations agreed upon by the workshop was published as ECETOC Workshop Report No. 12 (¿2). This report represents the summary findings of the task force, taking into consideration the consensus agreement of the workshop.