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Related Experiment Videos

The OECD program to validate the rat uterotrophic bioassay. Phase 2: coded single-dose studies.

Jun Kanno1, Lesley Onyon, Shyamal Peddada

  • 1National Institute of Health Sciences, Tokyo, Japan.

Environmental Health Perspectives
|September 2, 2003
PubMed
Summary

The rodent uterotrophic bioassay demonstrated high reproducibility across 16 international laboratories. This validation confirms its ability to reliably detect weak estrogen agonists, supporting its use in chemical safety assessments.

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Area of Science:

  • Endocrinology
  • Toxicology
  • Reproductive Science

Background:

  • The Organisation for Economic Co-operation and Development (OECD) conducted Phase 2 of an international validation program for the rodent uterotrophic bioassay.
  • This phase focused on assessing the assay's reproducibility using various estrogen receptor agonists and a nonagonist.
  • Estrogenicity testing is crucial for evaluating potential endocrine-disrupting chemicals.

Purpose of the Study:

  • To evaluate the reproducibility of the rodent uterotrophic bioassay across multiple international laboratories.
  • To determine the assay's ability to detect both potent and weak estrogen agonists, as well as nonagonists.
  • To validate standardized protocols for the uterotrophic bioassay.

Main Methods:

  • Sixteen laboratories participated in Phase 2 of the validation program.

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  • Test substances included 17-ethinyl estradiol (potent agonist), bisphenol A, genistein, methoxychlor, nonylphenol, o,p -DDT (weak agonists), and n-dibutylphthalate (nonagonist).
  • Two assay versions (intact immature and adult ovariectomized rats) and four protocols (subcutaneous and oral administration) were employed.

    • Main Results:

    • The rodent uterotrophic bioassay demonstrated reproducible results within and across participating laboratories for all tested substances and protocols.
    • The assay successfully identified both potent and weak estrogen agonists, as well as the negative control.
    • Reproducibility was achieved despite variations in experimental conditions such as animal strain, diet, and housing.

    Conclusions:

    • Both versions of the uterotrophic bioassay and all tested protocols are robust, reproducible, and transferable across laboratories.
    • The assay is effective in detecting weak estrogen agonists.
    • These findings support the validation of the rodent uterotrophic bioassay for regulatory purposes.