Draft Performance Standards for the BG1Luc Estrogen Receptor (ER) Transactivation in Vitro Assay to Detect ER Antagonists for TG 457 INTRODUCTION

1. These Performance Standards (PS) accompany the BG1Luc Estrogen Receptor (ER) Transactivation (TA) Test Method for Identifying ER Agonists and Antagonists (TG 457) (1). Prior to the acceptance of a new test method for regulatory testing applications, validation studies are conducted to assess its reliability (i.e., the extent of intraand inter-laboratory reproducibility over time when performed using the standardized protocol) and its relevance (i.e., the ability of the test method to correctly predict or measure the biological effect of interest) (2) (3) (4) (5). The purpose of performance standards is to communicate the basis by which new proprietary (i.e. copyrighted, trademarked, registered) and non-proprietary test methods have been determined to have sufficient accuracy (i.e., agreement between a test method result and an accepted reference value) and reliability (i.e., extent that a test method can be performed reproducibly within and between laboratories over time, when performed using the same protocol) for a specific testing purpose. New test methods (i.e., “me-too” tests) can be added to TG 457. The Mutual Acceptance of Data will only be guaranteed if any proposed new or updated similar test method, developed according to these Performance Standards (for estrogen antagonist), and to the Performance Standards developed for TG 455 (for estrogen agonist), has been reviewed and adopted by the OECD.