Performance Standards for the Assessment of Proposed Similar or Modified In Vitro Reconstructed Human Epidermis (RhE) Test Methods for Skin Irritation Testing as described in TG 439

The purpose of Performance Standards (PS) is to provide the basis by which new similar or modified test methods, both proprietary (i.e. copyrighted, trademarked, registered) and non-proprietary,can be deemed to be structurally and mechanistically similar to a Validated Reference Method (VRM) and demonstrate to have sufficient reliability and relevance for specific testing purposes (i.e., scientifically valid), in accordance with the principles of Guidance Document No. 34. This document contains the Performance Standards (PS) for the validation of similar or modified RhE methods for skin irritation testing as described in TG 439. In the past, PS were usually annexed to TGs. However, in view of separating information on the use of a test method as contained in the TG from information needed to validate test methods as contained in the PS, TGs and PS will now both be stand alone documents.