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Regul Toxicol Pharmacol. 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).

Author information

1
Ubrs GmbH, Basel, Switzerland.
2
WIL Research Europe BV, s'-Hertogenbosch, The Netherlands.
3
Shell International BV, The Hague, The Netherlands.
4
ExxonMobil Biomedical Sciences Inc., Annandale, NJ, USA.
5
ExxonMobil Petroleum and Chemical, Brussels, Belgium.
6
BASF SE, Ludwigshafen, Germany.
7
European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium. Electronic address: alan.poole@ecetoc.org.

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

PMID:
27245879
DOI:
10.1016/j.yrtph.2016.05.036
[Indexed for MEDLINE]
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