Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 80, Issue -, Pages 32-40Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yrtph.2016.05.036
Keywords
Cohorts; EOGRTS; Extended one-generation reproductive toxicity study; Developmental toxicity; Fertility; Rat; Reproduction; Triggers
Categories
Funding
- ECETOC
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The extended one-generation reproduction toxicity study (EOGRTS; OECD test guideline 433) is a new and technically complex design to evaluate the putative effects of chemicals on fertility and development, including effects upon the developing nervous and immune systems. In addition to offering a more comprehensive assessment of developmental toxicity, the EOGRTS offers important improvements in animal welfare through reduction and refinement in a modular study design. The challenge to the practitioner is to know how the modular aspects of the study should be triggered on the basis of prior knowledge of a particular chemical, or on earlier findings in the EOGRTS itself, requirements of specific regulatory frameworks notwithstanding. The purpose of this document is to offer guidance on science based triggers for these extended evaluations. (C) 2016 The Authors. Published by Elsevier Inc.
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