Conventional Test Method:

Two-Generation Reproductive Toxicity (OECD TG 416)

Alternative Test Method:

Name & Description:

CertiChem Inc. MCF-7 Cell Proliferation Assay of Estrogenic Activity

This measures whether, and to what extent, a substance induces cell proliferation via estrogen receptor (ER) mediated pathways. Testing is done using MCF-7 cells, an immortalized human breast adenocarcinoma cell line that endogenously expresses ERs.

Validation Status:

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.

Regulatory Status:

No information

Effect or Potential Effect on Animal Use:

Replacement

OR

Reduction
(as part of a tiered testing strategy)

References:

• CertiChem (2006) Test Method Nomination: MCF-7 Cell Proliferation Assay of Estrogenic Activity.
• ICCVAM (2008) Validation of CertiChem Inc. MCF-7 Cell Proliferation Assay.
• NICEATM (2006) NICEATM Pre-screen evaluation of the in vitro endocrine disruptor assay (robotic MCF-7 cell proliferation assay of estrogenic activity).
• NICEATM-ICCVAM (2012) Validation of CertiChem Inc. MCF-7 Cell Proliferation Test Method.

Information Last Reviewed:

May 2012