Endocrine Effects

Conventional
test method

Alternative Test Method

Last Reviewed
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Two-Generation Reproductive Toxicity
(OECD TG 416)
Microsomal Aromatase Assays
(used in conjunction with either Pubertal Male In Vivo Assay or Adult Male In Vivo Assay).
Description and references
US: Validated by EPA for identifying aromatase-inhibiting chemicals (2007) US: The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) recommended that the EPA consider the use of these assays in a tier I screening test battery for the Endocrine Disruptor Screening Program (EDSP) (2007). Reduction May 2012
In Vitro Androgen Receptor Binding Assay (Rat Ventral Prostate Cytosol)
Description and references
US: Pre-validation by ICCVAM (2002); validation by EPA (2007) US: The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) recommended that the EPA use androgen receptor assays in a tier I screening test battery for the Endocrine Disruptor Screening Program (EDSP) (2007). 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)
May 2012
Human Recombinant Estrogen Receptor-α Binding Assays
Description and references
OECD: Presently conducting validation

US: In 2003, ICCVAM recommended that recombinant estrogen receptor binding assays undergo validation studies, though they still require standardization. A 2006 addendum revised the original list of 78 substances recommended for validation.

OECD: Draft of new test guidelines proposed (two protocols)

US: The Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) recommended that the EPA use estrogen receptor assays in a tier I screening test battery for the Endocrine Disruptor Screening Program (EDSP) (2007).

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)
May 2012
Stably Transfected Human Estrogen-α Transcriptional Activation Assay for the Detection of Estrogenic Agonist-Activity of Chemicals (using hER-HeLa-9903 cell line)
Description and references
OECD: Validated OECD: TG 455 (2013) 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)
June 2014
BG1Luc Estrogen Receptor Transactivation Assay for Identifying Estrogen Receptor Agonists and Antagonists
Description and references
OECD: Validated

US: Validated by the ICCVAM

OECD: 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).

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)
June 2014
H295R Cell-Based Steroidogenesis Assay
Description and references
OECD: Presently conducting validation
(lead agency is US EPA)
OECD: TG 456 (2011)

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).

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)
May 2012
CertiChem Inc. MCF-7 Cell Proliferation Assay of Estrogenic Activity
Description and references
US: An intralaboratory validation study has been initiated at CertiChem laboratories. ICCVAM has recommended that the assay be given a high priority for additional validation. No information Replacement

OR

Reduction
(as part of a tiered testing strategy)

May 2012

 

List of Abbreviations

Test Methods Categories

Toxicity
Dermal Tests
Vaccines