LUMI-CELL (Trade Name) ER (BG1Luc ER TA) Test Method: An In Vitro Assay for Identifying Human Estrogen Receptor Agonist and Antagonist Activity of Chemicals. ICCVAM Test Method Evaluation Report.

摘要

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has completed its evaluation of the validation status of the LUMI-CELL (Trade Name) BG1Luc4E2 estrogen receptor (ER) transcriptional activation (TA) test method (hereafter BG1Luc ER TA test method) as a screening test to identify substances with in vitro ER agonist and antagonist activity. The BG1Luc ER TA test method uses BG-1 cells, a human ovarian adenocarcinoma cell line that is stably transfected with an estrogen-responsive luminescence (luciferase reporter) gene, to measure whether and how much a substance induces (agonist) or inhibits (antagonist) TA activity via ER-mediated pathways. Such substances could interfere with the normal function of hormones in the endocrine system (i.e., endocrine disruptors), which may lead to abnormal growth, development, or reproduction. This test method evaluation report provides ICCVAM’s recommendations for the BG1Luc ER TA test method based on the results of an international validation study and the demonstrated validity (usefulness and limitations). The report also includes (1) recommendations for future studies, (2) performance standards to evaluate functionally and mechanistically similar test methods, (3) protocols recommended by ICCVAM for future data collection and evaluation of the BG1Luc ER TA test method, and (4) a final background review document (BRD) describing the validation status of this test method.