Conventional Test Method:

Two-Generation Reproductive Toxicity (OECD TG 416)

Alternative Test Method:

Name & Description:

BG1Luc Estrogen Receptor Transactivation Assay for Identifying Estrogen Receptor Agonists and Antagonists

This method measures whether and to what extent a substance induces or blocks transcriptional activation via estrogen receptor (ER) –mediated pathways in the BG-1Luc4E2 cell line. This cell line expresses luciferase activity in response to estrogen and estrogen-like substances.

Validation Status:

OECD: Validated

US: Validated

Regulatory Status:

OECD: TG 457 (2012)

US: The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) recommended that the EPA consider the use of this assay 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:
June 2014