“Regulatory acceptance and use of the Extended One Generation Reproductive Toxicity Study within Europe”

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“Regulatory acceptance and use of the Extended One Generation Reproductive Toxicity Study within Europe”

In this paper published recently in Regulatory Toxicology and Pharmacology, Marie-Jeanne W.A. Schiffelers and co-authors reconstruct and analyze the process of regulatory acceptance and use of the Extended One Generation Reproductive Toxicity Study as a replacement for the two generation study. (Disclosure: AltTox Management Team member Bas J. Blaauboer is one of the co-authors on this paper.)

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. The regulatory acceptance and use of the EOGRTS within Europe has been a point of strong disparity. This raises the following key questions which will be addressed in this paper:

  • Which factors influence the regulatory acceptance and use of the EOGRTS within Europe?*
  • What is needed to augment the current process?
  • Which lessons can be drawn from the case of the EOGRTS for future processes?

To target these questions 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: (1) 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; (2) the stage of Actual Regulatory Acceptance within REACH was challenged by legal factors and ongoing scientific disputes, while (3) 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.

Article citation: Schiffelers, M.-J.W.A., Blaauboer, B.J., Bakker, W.E., Hendriksen, C.F.M., and Krul, C. Regulatory acceptance and use of the Extended One Generation Reproductive Toxicity Study within Europe. (In press.) Regulatory Toxicology and Pharmacology, http://dx.doi.org/10.1016/j.yrtph.2014.10.012.

*Although this paper focuses on the European situation major parts of the discussion in the US are also covered in this manuscript.

Posted: December 11, 2014