The Corrositex® assay measures the potential for a substance to cause skin corrosion by testing
if the substance can pass through a biobarrier by diffusion, erosion, or destruction. Penetration
of the biobarrier is detected by a color change in an underlying liquid Chemical Detection System.
An ICCVAM-sponsored independent Peer Review Panel (“Panel”) met in January 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 substances with
the potential to cause dermal corrosion. The Panel evaluation compared the performance of
Corrositex to that of the in vivo rabbit skin corrosivity test.
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. Used in
this manner, Corrositex can replace the use of animals for corrosivity testing of qualified
chemicals in some chemical classes. 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, thereby offering opportunities for reducing the number of animals used. A positive result
for corrosivity will usually eliminate the need for further animal testing, and when further testing
in animals is determined to be necessary, only one animal is required to confirm a corrosive chemical.
Finally, Corrositex provides for refinement in that most of the chemicals that are identified as negative
by Corrositex or nonqualifying in the detection system are unlikely to be corrosive when
tested on animals for irritation potential.
The Panel also concluded that Corrositex offers opportunities for reduction, refinement
(causing less pain and distress), and replacement of animals for the purpose of dermal
corrosivity testing. If the Corrositex assay is used as a stand-alone assay as described
above, it can replace the use of animals for corrosivity testing of qualified chemicals
in some chemical classes. If Corrositex is used as part of a tiered-testing strategy for
corrosivity, fewer animals will be required for testing. A positive result for corrosivity
will usually eliminate the need for further animal testing, and when further testing in
animals is determined to be necessary, only one animal is required to confirm a corrosive
chemical. Finally, Corrositex provides for refinement in that most of the chemicals that
are identified as negative by Corrositex or nonqualifying in the detection system are
unlikely to be corrosive when tested on animals for irritation potential.
Corrositex is accepted as an alternative to a procedure
specified in the U.S. Department of Transportation (DOT)
Hazardous Materials Regulations (DOT-SP 10904) for DOT packing group classification of corrosive
Peer Review Panel Report
Corrositex®: An In Vitro Test Method for Assessing Dermal Corrosivity Potential
of Chemcials - An Independent Peer Review Evaluation Coordinated by the Interagency
Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the
NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
NIH Publication Number 99-4495 (June 1999)
NIH Press Release (June 22, 1999): "Science Panel Endorses New Non-Animal Test
to See if Chemicals Will Burn, Corrode Skin and Eyes"
Recommendations were communicated to Federal agencies in letters from Dr. Kenneth Olden, former Director, NIEHS,
to the agency heads at that time. Links the responses from agency officials can be found below.
- Agency for Toxic Substances and Disease Registry
- Response from Henry Falk, M.D., M.P.H., Assistant Administrator (received Nov. 29, 1999) [PDF]
- Department of Defense
- Response from Robert E. Foster, Director, BioSystems (received July 14, 1999) [PDF]
- Environmental Protection Agency
- Response from Steven Galson, M.D., M.P.H., Director, Office of Science Coordination and Policy (received Jan. 3, 2000) [PDF]
- Food and Drug Administration
- Response from Linda Rosenstock, M.D., M.P.H., Director (received Dec. 13, 1999) [PDF]
Other Related Documents and Sites:
Organisation for Economic Co-operation and Development (OECD)
Guidelines for the Testing of Chemicals Test Guideline 435 [PDF]
In vitro membrane barrier methods such as Corrositex® are accepted internationally via OECD Test Guideline 435.
A Validated and Accepted Dermal Corrosion Test Method for Classifying Substances According to the UN Packing
Groups" (October 2003) [PDF]