Print Email Facebook Twitter Regulatory acceptance and use of the extended one generation reproductive toxicity study within Europe Title Regulatory acceptance and use of the extended one generation reproductive toxicity study within Europe Author Schiffelers, M.J.W.A. Blaauboer, B.J. Bakker, W.E. Hendriksen, C.F.M. Krul, C. Instituut CIVO-Toxicologie en Voeding TNO Publication year 2015 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. Subject LifeRAPID - Risk Analysis for Products in DevelopmentELSS - Earth, Life and Social SciencesBarriers and driversEOGRTSREACHRegulatory acceptance and useReproductive toxicity testingAnimaliaRattus To reference this document use: http://resolver.tudelft.nl/uuid:6ff88b75-8d62-4c54-96d1-bc15ed0d1b96 DOI https://doi.org/10.1016/j.yrtph.2014.10.012 TNO identifier 521643 ISSN 0273-2300 Source Regulatory Toxicology and Pharmacology, 71 (1), 114-124 Document type article Files To receive the publication files, please send an e-mail request to TNO Library.