title: Guidance on the selection of cohorts for the extended one-generation reproduction toxicity study (OECD test guideline 443).
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.
authors.affiliation: Ubrs GmbH, Basel, Switzerland.
authors.forename: Nigel P
authors.initials: NP
authors.lastname: Moore
authors.affiliation: WIL Research Europe BV, s'-Hertogenbosch, The Netherlands.
authors.forename: Manon
authors.initials: M
authors.lastname: Beekhuijzen
authors.affiliation: Shell International BV, The Hague, The Netherlands.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Boogaard
authors.affiliation: ExxonMobil Biomedical Sciences Inc., Annandale, NJ, USA.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Foreman
authors.affiliation: ExxonMobil Biomedical Sciences Inc., Annandale, NJ, USA.
authors.forename: Colin M
authors.initials: CM
authors.lastname: North
authors.affiliation: ExxonMobil Petroleum and Chemical, Brussels, Belgium.
authors.forename: Christine
authors.initials: C
authors.lastname: Palermo
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Schneider
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Strauss
authors.affiliation: BASF SE, Ludwigshafen, Germany.
authors.forename: Bennard
authors.initials: B
authors.lastname: van Ravenzwaay
authors.affiliation: European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium. Electronic address: alan.poole@ecetoc.org.
authors.forename: Alan
authors.initials: A
authors.lastname: Poole
mesh_terms: D000818:Animals; D005260:Female; D005298:Fertility / Q000187:drug effects*; D006801:Humans; D007107:Immune System / Q000187:drug effects / Q000254:growth & development; D008297:Male; D023421:Models, Animal; D009420:Nervous System / Q000187:drug effects / Q000254:growth & development; D066150:Organisation for Economic Co-Operation and Development / Q000592:standards; D051381:Rats; D012098:Reproduction / Q000187:drug effects*; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods* / Q000592:standards
keywords: Cohorts; Developmental toxicity; EOGRTS; Extended one-generation reproductive toxicity study; Fertility; Rat; Reproduction; Triggers