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:

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:

• EPA (2005) Final detailed review paper on steroidogenesis screening assays and endocrine disruptors.
• EPA (n.d.) Steroidogenesis (H295R) Fact Sheet.
• EPA (2009) Endocrine Disruptor Screening Program Test Guidelines OPPTS 890.1550: Steroidogenesis (Human Cell Line – H295R).
• Hecker M., Timm G. and Giesy J.P. Development and pre-validation of a H295R cell line screening test to evaluation toxicant-induced effects on steroidogenesis.
• OECD (2011) Test No. 456: H295R Steroidogenesis, OECD Guidelines for the Testing of Chemicals, Section 4 Health Effects.

Information Last Reviewed:

May 2012