Corrositex Test Method for Dermal Corrosivity Testing
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. ICCVAM convened an independent peer review panel meeting in January 1999 to evaluate Corrositex for the identification of potential dermal corrosives. 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 and can replace the use of animals. The panel also concluded that, in other testing circumstances and for other chemical and product classes, Corrositex may be used as part of a tiered assessment strategy. A positive result for corrosivity will usually eliminate the need for further animal testing; when further testing in animals is determined to be necessary, only one animal is required to confirm a corrosive chemical. 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. Read Additional Panel Recommendations
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 materials.
Peer Review Panel Report
Corrositex®: An In Vitro Test Method for Assessing Dermal Corrosivity Potential of Chemicals
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)
Agency Responses to Panel Recommendations
Recommendations were communicated to Federal agencies in letters from NIEHS Director Dr. Kenneth Olden 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)
- Department of Defense
- Response from Robert E. Foster, Director, BioSystems (received July 14, 1999)
- Environmental Protection Agency
- Response from Steven Galson, M.D., M.P.H., Director, Office of Science Coordination and Policy (received Jan. 3, 2000)
- National Institute for Occupational Safety and Health
- Response from Linda Rosenstock, M.D., M.P.H., Director (received Dec. 13, 1999)
Other Related Documents and Sites
Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals Test Guideline 435
In vitro membrane barrier methods such as Corrositex® are accepted internationally via OECD Test Guideline 435.
InVitro International's Corrositex® Site
SAMPLE PROTOCOL: "Corrositex® - A Validated and Accepted Dermal Corrosion Test Method for Classifying Substances According to the UN Packing Groups" (October 2003)