National Toxicology Program

Corrositex® is based on the ability of a corrosive chemical or chemical mixture to pass through a biobarrier, by diffusion and/or destruction/erosion, and to elicit a color change in the underlying liquid Chemical Detection System (CDS). An independent Peer Review Panel (PRP) was assembled on Jan. 21, 1999, to evaluate the extent to which each of the ICCVAM validation and acceptance criteria had been addressed, and to determine the usefulness and limitations of Corrositex® for the identification of potential human corrosive chemicals or chemical mixtures. The PRP evaluation focused on the performance of Corrositex® compared to the in vivo rabbit skin corrosivity test. The ICCVAM Peer Review Panel evaluation of Corrositex® was reviewed for acceptance by the ICCVAM Corrosivity Working Group (CWG), renamed the beginning of 2003 to the Dermal Corrosivity and Irritation Working Group. The Panel concluded that for certain testing circumstances, such as testing performed to comply with the U.S. Department of Transportation regulations, Corrositex® is useful as a stand-alone assay for evaluating the corrosivity or noncorrosivity of acids, bases, and acid derivatives. In other testing circumstances, and for other chemical and product classes, the Panel concluded that Corrositex® may be used as part of a tiered assessment strategy. The peer review panel also concluded that Corrositex® offers advantages with respect to animal welfare considerations.

The EpiDerm™ (EPI-200) is a three-dimensional human skin model that uses cell viability as a measure of corrosivity. EPISKIN™ is a three-dimensional human skin model comprised of a reconstructed epidermis and a functional stratum corneum. The test material is topically applied to the skin with subsequent assessment of the effects on cell viability. In the TER Assay, corrosive materials are identified by the ability to produce a loss of normal stratum corneum integrity and barrier function, which is measured as a reduction of the inherent transcutaneous electrical resistance below a predetermined threshold level.