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 |
