Conventional Test Method:

Two-Generation Reproductive Toxicity (OECD TG 416)

Alternative Test Method:

Name & Description:

Stably Transfected Human Estrogen-α Transcriptional Activation Assay for the Detection of Estrogenic Agonist-Activity of Chemicals (using hER-HeLa-9903 cell line)

The hER-HeLa-9903 cell line is used to detect transcriptional activation mediated through human estrogen receptor alpha (hERα). When estrogen binds to hER-α, the receptor-ligand complex is translocated to the nucleus where it activates a luciferase reporter gene. Bioluminescence is measured with a luminometer.

Validation Status:

OECD: Validated

Regulatory Status:

OECD: TG 455 (2013)

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:

• CERI (2006) Draft pre-validation report of TA assay using HeLa-hER-9903 to detect estrogenic activity.
• ICCVAM (2007) Comments on the draft OECD STTA Assay Test Guideline.
• OECD (2013) Test No. 455: Performance-Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists, OECD Guidelines for the Testing of Chemicals, Section 4 Health Effects.

Information Last Reviewed:

June 2014