Conventional Test Method:

Two-Generation Reproductive Toxicity (OECD TG 416)

Alternative Test Method:

Name & Description:

In Vitro Androgen Receptor Binding Assay (Rat Ventral Prostate Cytosol)

This assay identifies the potential of the test compound to interact with and disrupt androgen systems. The test compound is measured for its ability to bind to androgen receptors (ARs), as well its affinity for the ARs in comparison to radiolabeled androgen.

Validation Status:

US: Pre-validation by ICCVAM (2002); validation by EPA (2007)

Regulatory Status:

US: The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) recommended that the EPA use androgen receptor assays in a tier I screening test battery for the Endocrine Disruptor Screening Program (EDSP) (2007).

Effect or Potential Effect on Animal Use:

(A negative result in the tier I test battery is sufficient to classify a chemical as having  low or no potential to cause endocrine disruption, thus avoiding tier II animal tests)

Information Last Reviewed:
May 2012