Performance Standards for the assessment of proposed similar or modified in vitro macromolecular test method for identifying eye hazard potential as described in Test Guideline 496

The purpose of Performance Standards (PS) is to provide a basis by which proposed similar or modified test methods, both proprietary (i.e., copyrighted, trademarked, or registered) and non-proprietary, can be deemed to be structurally and mechanistically similar to a Validated Reference Method (VRM) as well as can be shown to be scientifically valid, with sufficient reliability and relevance for the specific testing purposes. This document contains the Performance Standards (PS) for determining the reliability and relevance of similar and modified test methods for ocular hazard that are structurally and mechanistically similar to the in vitro macromolecular test method described in TG 496 and the DB-ALM protocol n. 157, in accordance with the principles of Guidance Document No. 34.