Nigel Moore, Susanne Bremer, Neil Carmichael, George Daston, Matt Dent, Wassila Gaoua-Chapelle, Nina Hallmark, Thomas Hartung,a Beate Holzum, Ulrich Hübel, Marie-Louise Meisters, Steffen Schneider, Bennard van Ravenzwaay and Christa Hennes
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 Co-operation and Development (OECD). The initial phase of the work was concerned with reviewing 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, the aim was to design an intelligent testing strategy for reproductive and developmental endpoints, which would be 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 toxicity study. An additional aim was to describe the extent to which these trigger and waiving criteria could already be considered to be validated, and to propose additional validation steps, if needed.
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