OECD Standards for in vitro skin sensitization, including list of reference chemicals for determination of reproducibility and predictive capacity
Performance standards (PS) have been developed to facilitate the validation of proposed similar or modified test methods based on the Direct Peptide Reactivity Assay (DPRA) and the Amino acid Derivative Assay (ADRA) and to allow for their timely inclusion in the Test Guidelines (1) (2). Proposed similar or modified test methods based on in chemico covalent binding to proteins will only be added to the Test Guideline, however, after a review process to confirm that all criteria stipulated in the PS for similarity to the validated reference methods (VRM)—namely, DPRA and ADRA—have been met, that the proposed similar or modified test method includes all essential test method components, and that test performance achieves the target values for reproducibility and predictive capacity of the proposed reference chemicals. 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.
The purpose of these Performance Standards (PS) is to provide a basis by which proposed similar or modified test methods, both proprietary (i.e., copyrighted, trademarked, registered) and non-proprietary, can demonstrate sufficient reliability and relevance for testing purposes. The PS, based on a scientifically valid and accepted test method, can be used to evaluate the reliability and relevance of other analogous test methods (colloquially referred to as “me-too” test methods) that are based on similar scientific principles and measure or predict the same biological or toxic effect.
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