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Guideline
. 2016 Oct;80:32-40.
doi: 10.1016/j.yrtph.2016.05.036. Epub 2016 May 28.

Guidance on the Selection of Cohorts for the Extended One-Generation Reproduction Toxicity Study (OECD Test Guideline 443)

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Guideline

Guidance on the Selection of Cohorts for the Extended One-Generation Reproduction Toxicity Study (OECD Test Guideline 443)

Nigel P Moore et al. Regul Toxicol Pharmacol. .

Abstract

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.

Keywords: Cohorts; Developmental toxicity; EOGRTS; Extended one-generation reproductive toxicity study; Fertility; Rat; Reproduction; Triggers.

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