Regulatory acceptance and use of the Extended One Generation Reproductive Toxicity Study within Europe
| Autor: | Schiffelers, Marie-Jeanne W. A., Blaauboer, Bas J., Bakker, Wieger E., Hendriksen, Coenraad F. M., Krul, Cyrille, Public Management, LS IRAS Tox CMT/ATX, Dep Bestuurs- en Organisatiewetenschap, Public Governance, Sub 3V Centrum ULS, Risk Assessment of Toxic and Immunomodulatory Agents, IRAS RATIA1, UU LEG Research USG Public Matters |
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| Přispěvatelé: | Public Management, LS IRAS Tox CMT/ATX, Dep Bestuurs- en Organisatiewetenschap, Public Governance, Sub 3V Centrum ULS, Risk Assessment of Toxic and Immunomodulatory Agents, IRAS RATIA1, UU LEG Research USG Public Matters |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Regulatory acceptance and use
MULTILEVEL PERSPECTIVE 2-GENERATION Guidelines as Topic Legislation Toxicology EOGRTS CHEMICALS RETROSPECTIVE ANALYSIS MULTIGENERATION Toxicity Tests Taverne False positive paradox Production (economics) Relevance (law) Operations management 3R MODELS Barriers and drivers Public economics Animal Welfare (journal) Reproduction ANIMALS General Medicine Test (assessment) Europe Reproductive toxicity testing Literature research 2ND-GENERATION Chemical Industry SAFETY Government Regulation REACH Business Reproductive toxicity |
| Zdroj: | Regulatory Toxicology and Pharmacology, 71(1), 114. Academic Press Inc. |
| ISSN: | 0273-2300 |
| Popis: | 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. (C) 2014 Elsevier Inc. All rights reserved. |
| Databáze: | OpenAIRE |
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