Recommended Performance Standards for 'In vitro' Test Methods for Skin Corrosion

摘要

This document describes the performance standards that should be met by in vitro corrosivity test methods that utilize membrane barrier test systems, cultured human skin model systems, or the rat skin TER test method. These three types of in vitro corrosivity test methods have been recommended by ICCVAM as screening assays to identify corrosive substances based on data from the respective validated reference test method. The extent to which proposed test methods that are mechanistically and functionally similar to the validated reference test methods must demonstrate comparable performance should be considered on a case-by-case basis. The purpose of performance standards is to communicate the basis by which validated new proprietary (e.g., copyrighted, trademarked, registered) and nonproprietary test methods have been determined to have sufficient accuracy and reliability for specific testing purposes. Performance standards can then be used to evaluate the accuracy and reliability of other test methods that are based on similar scientific principles and that measure or predict the same biological or toxic effect. The three elements of performance standards are: (1) essential test method components (i.e., structural, functional, and procedural elements of a validated test method that a proposed, mechanistically and functionally similar test method should adhere to); (2) a minimum list of reference chemicals that is used to assess the accuracy and reliability of the proposed test method; and (3) the accuracy and reliability values that should be achieved by the proposed test method when evaluated using the minimum list of reference chemicals.