Conventional Test Method:

Two-Generation Reproductive Toxicity (OECD TG 416)

Alternative Test Method:

Alternative Test Method:
Name & Description:

Human Recombinant Estrogen Receptor-α Binding Assays

These assays identify the potential of the test compound to interact with and disrupt estrogen systems. The test compound is measured for its ability to bind to estrogen receptors (ERs), as well its affinity for the ERs in comparison to a standardized estrogenic compound.

Validation Status:

OECD: Presently conducting validation

US: In 2003, ICCVAM recommended that recombinant estrogen receptor binding assays undergo validation studies, though they still require standardization. A 2006 addendum revised the original list of 78 substances recommended for validation.

Regulatory Status:

OECD: Draft of new test guidelines proposed (two protocols)

US: The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) recommended that the EPA use estrogen 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