Performance Standards for Assessment of Proposed Similar or Modified in Vitro Skin Sensitisation Il-8 Luc Assay

INTRODUCTION 1. Performance standards (PS) have been developed to facilitate the validation of proposed similar or modified versions of the in vitro IL-8 Luc assay and to allow for their timely inclusion in the Test Guideline (1). Similar or modified versions of the in vitro IL-8 Luc assay will only be added to the Test Guideline after review and agreement that all criteria described in the PS are met, including similarity to the IL-8 Luc assay (the validated reference method, VRM) according to the essential test method components and achievement of the target values for reproducibility and predictive capacity for the proposed reference substances. Mutual Acceptance of Data (MAD) will only be guaranteed for test methods validated according to the PS if these test methods have been reviewed and included in this Test Guideline by the OECD.