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:

Reduction
(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)

References:

• Xenobiotic Detection Systems Inc. (XDS) (2005) Submission of XDS’s LUMI-CELL^TM ER high-throughput system for screening estrogen-like chemicals for review by ICCVAM.
• ICCVAM (2008) Validation of Xenobiotic Detection Systems, Inc. LUMI-CELL assay of estrogenic activity.
• NICEATM-ICCVAM (2012) Validation of the BG1Luc Estrogen Receptor Transcriptional Activation Test Method.
• OECD (2012) Test No. 457: BG1Luc Estrogen Receptor Transactivation Test Method for Identifying Estrogen Receptor Agonists and Antagonists, OECD Guidelines for the Testing of Chemicals, Section 4.

Information Last Reviewed:

June 2014