Corrositex® Assay
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.
EpiDermTM, EpiSkinTM and Rat Skin Transcutaneous
Electrical Resistance (TER) Assays
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.
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