title: Regulatory acceptance and use of the Extended One Generation Reproductive Toxicity Study within Europe.
abstract: The two-generation study (OECD TG 416) is the standard requirement within REACH to test reproductive toxicity effects of chemicals with production volumes >100 tonnes. This test is criticized in terms of scientific relevance and animal welfare. The Extended One Generation Reproductive Toxicity Study (EOGRTS), incorporated into the OECD test guidelines in 2011 (OECD TG 443) has the potential to replace TG 416, while using only one generation of rats and being more informative. However, its regulatory acceptance proved challenging. This article reconstructs the process of regulatory acceptance and use of the EOGRTS and describes drivers and barriers influencing the process. The findings derive from literature research and expert interviews. A distinction is made between three sub-stages; The stage of Formal Incorporation of the EOGRTS into OECD test guidelines was stimulated by retrospective analyses on the value of the second generation (F2), strong EOGRTS advocates, animal welfare concern and changing US and EU chemicals legislation; the stage of Actual Regulatory Acceptance within REACH was challenged by legal factors and ongoing scientific disputes, while the stage of Use by Industry is influenced by uncertainty of registrants about regulatory acceptance, high costs, the risk of false positives and the manageability of the EOGRTS.
authors.affiliation: Utrecht University School of Governance, Bijlhouwerstraat 6, 3511 ZC Utrecht, The Netherlands. Electronic address: m.j.w.a.schiffelers@uu.nl.
authors.forename: Marie-Jeanne W A
authors.initials: MJ
authors.lastname: Schiffelers
authors.affiliation: Utrecht University, Institute for Risk Assessment Sciences (IRAS), P.O. Box 80.178, 3508 TD Utrecht, The Netherlands.
authors.forename: Bas J
authors.initials: BJ
authors.lastname: Blaauboer
authors.affiliation: Utrecht University School of Governance, Bijlhouwerstraat 6, 3511 ZC Utrecht, The Netherlands.
authors.forename: Wieger E
authors.initials: WE
authors.lastname: Bakker
authors.affiliation: Utrecht University, Faculty of Veterinary Medicine, Department Animals in Science and Society, P.O. Box 80.163, 3508 TD Utrecht, The Netherlands; Institute for Translational Vaccinology (Intravacc), P.O. Box 450, 3720 AL Bilthoven, The Netherlands.
authors.forename: Coenraad F M
authors.initials: CF
authors.lastname: Hendriksen
authors.affiliation: TNO, P.O. Box 360, 3700 AJ Zeist, The Netherlands; University of Applied Sciences Utrecht, Life Sciences & Chemistry, F.C. Dondersstraat 65, 3572 JE Utrecht, The Netherlands.
authors.forename: Cyrille
authors.initials: C
authors.lastname: Krul
mesh_terms: D002617:Chemical Industry / Q000331:legislation & jurisprudence*; D005060:Europe; D033161:Government Regulation; D017408:Guidelines as Topic; D012098:Reproduction / Q000187:drug effects*; D018675:Toxicity Tests / Q000379:methods*
keywords: Barriers and drivers; EOGRTS; REACH; Regulatory acceptance and use; Reproductive toxicity testing