OECD Hershberger Bioassay Validation Study
Author Information
Author(s): Williams Owens, Errol Zeiger, Michael Walker, John Ashby, Lesley Onyon, Earl Gray Jr.
Primary Institution: Procter & Gamble
Hypothesis
The OECD Hershberger bioassay can effectively screen for in vivo androgen and antiandrogen responses.
Conclusion
The OECD Hershberger protocol was found to be robust, reproducible, and transferable across laboratories.
Supporting Evidence
- All laboratories successfully detected increases in tissue weight when testosterone propionate was administered.
- Flutamide co-administration led to significant decreases in tissue weights.
- The standardized protocols performed well under various laboratory conditions.
- Statistical analyses confirmed the robustness of the assay.
- Results indicated that the protocols are adequate for proceeding to the next phase of validation.
Takeaway
This study tested a method to see how certain chemicals affect male reproductive organs in rats, and it worked well across different labs.
Methodology
The study involved 17 laboratories testing the effects of testosterone propionate and flutamide on male sex accessory tissues in castrated rats.
Limitations
The study did not include a clear consensus on which male reproductive tract tissues to include in the assay.
Participant Demographics
Laboratories from 7 countries participated, including France, Germany, Denmark, Japan, Korea, the United Kingdom, and the United States.
Statistical Information
P-Value
p<0.05
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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