Conventional Test Method:

Two-Generation Reproductive Toxicity (OECD TG 416)

Alternative Test Method:

Name & Description:

H295R Cell-Based Steroidogenesis Assay

This assay provides an in vitro cell-based assay to detect chemicals that affect the synthesis of the sex steroid hormones.

Validation Status:

OECD: Presently conducting validation (lead agency is US EPA)

Regulatory Status:

OECD: Draft new Test Guideline proposed

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:
May 2012