Validation Study Report: Performance assessment of the AR-CALUX® in vitro method: to support the development of an international test guideline for Androgen Receptor Transactivation Assays (ARTA) for the detection of compounds with (anti)androgenic potential

Abstract

The JRC’s EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) conducted a validation study of the AR-CALUX in vitro method. The method is applied to the detection of compounds with endocrine disrupting potential and more specifically (anti)androgen activity. The objectives of the study included assessing the reproducibility (within and between laboratories) and the relevance of the in vitro method. The participating laboratories included three test facilities from the European Union Network of Validation Laboratories for alternative methods (EU-NETVAL), being RISE, Covance, and Charles River, and, the test method submitter Biodetection Systems. The validation study report presents the results of the method performed on 46 test chemicals, evaluated for reproducibility within and between laboratories, variability within the measurements, and classification. A comparison of the classifications was made with publicly available ARTA classifications. It was concluded that this test method is reliable, has high reproducibility, low variability and merits proposal to OECD for the development of a test guideline. The statistical report and the final SOP are part of this report and can be found as separate files.