Performance standards are based on an adequately validated test method and provide a basis for evaluating the comparability of a proposed test method that is mechanistically and functionally similar.
Read this first: As indicated in the Performance Standards documents below, similar methods to the Validated Reference Method(s) should not be developed on the basis of a majority of reference substances, but rather on a larger set of tested chemicals. Reference substances should be preferentially used to determine equivalence of performance compared to the validated reference test methods.
The three elements of performance standards are:
No. 356 Performance Standards for the Assessment of Proposed Similar or Modified in Vitro Phototoxicity: Reconstructed Human Epidermis (RhE) Test Methods for Testing of Topically Applied Substances, as described in Test Guideline 498
No. 313 Performance Standards for the assessment of proposed similar or modified Vitrigel-Eye Irritancy method for Test Guideline 494
No. 312 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
No. 303 Performance Standards for the assessment of proposed similar or modified in vitro skin sensitisation DPRA and ADRA test methods
No. 222 Performance Standards for the Human Recombinant Estrogen Receptor Binding Assay
No. 220 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
No. 219 Performance Standards for the Assessment of Proposed Similar or Modified In Vitro Reconstructed Human Epidermis (RHE) Test Methods for Skin Corrosion Testing as described in TG 431
No. 218 Performance Standards for the Assessment of Proposed Similar or Modified In Vitro Reconstructed Human Epidermis (RHE) Test Methods for Skin Corrosion Testing as described in TG 430
No. 216 Performance Standards for the Assessment of proposed Similar or Modified In Vitro Reconstructed Human Cornea-like Epithelium (RHCE) Test Methods for Eye Hazard
No. 213: Performance Standards for Assessment of Proposed Similar or Modified In Vitro Skin Sensitisation ARE-NRF2 Luciferase Test Methods
No. 174: Second Edition Performance Standards For Stably Transfected Transactivation In Vitro Assays To Detect Estrogen Receptor Antagonists
No. 173: Performance Standards for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Agonists for TG 455
Further Reading
ENGAGE WITH US
Related Documents