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Performance Standards for In Vitro Test Methods for Skin Corrosion

At the request of the U.S. Environmental Protection Agency, ICCVAM established performance standards for in vitro test methods for skin corrosion. These performance standards were based on ICCVAM evaluations of in vitro methods—in particular, in vitro methods to identify potential dermal corrosives. The resulting document delivers performance standards to evaluate the usefulness and limitations of other test methods that are based on similar scientific principles.

After the performance standards were published, ICCVAM and NICEATM drafted proposed updates to Organisation for Economic Co-operation and Development (OECD) test guidelines. These proposed updates include in vitro methods for identifying skin corrosives (OECD Test Guidelines 430 and 431). These updates, which were based on the ICCVAM performance standards, were adopted by OECD in 2013. The U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration revised its hazardous materials regulations to include acceptance of the in vitro methods described in OECD Test Guidelines 430 and 431. Substances with negative tests using these methods can be assigned to packing groups without further testing, reducing animal use for this purpose.

Details of the Performance Standards

The three elements of performance standards are:

  • Essential test method components (a list of specifically required structural, functional, and procedural elements which are derived from mechanistically and functionally similar validated test methods)
  • A minimum list of reference substances to be used to assess the accuracy and reliability of the proposed test method
  • Accuracy and reliability values that should be achieved by the proposed test method when evaluated using the minimum list of reference chemicals

The ICCVAM performance standards for in vitro skin corrosion test methods describe standards that should be met by:

  • In vitro corrosivity test methods utilizing membrane barrier test systems
  • Cultured human skin model systems
  • The rat skin transcutaneous electrical resistance test method