EPISKIN, EpiDerm, and Rat Skin Transcutaneous Electrical Resistance Assay
Dermal corrosives are substances that can cause burns or permanent scarring to the skin. ICCVAM has recommended that three in vitro methods may be used for identifying potential dermal corrosives. These methods are used in a weight-of-evidence approach as part of an integrated testing scheme. In this approach, positive in vitro corrosivity responses can be used for classification and labeling without further testing.
ICCVAM Test Method Evaluation Report
ICCVAM Evaluation of EPISKIN™, EpiDerm™ (EPI-200), and the Rat Skin Transcutaneous Electrical Resistance (TER) Assay: In Vitro Test Methods for Assessing the Dermal Corrosivity Potential of Chemicals
(NIH Publication No. 02-4502, June 2002)
Regulatory agencies require testing to identify dermal corrosives. Results of these tests are used to label substances so that users can take appropriate safety precautions; to determine appropriate packaging requirements; and to develop safe handling procedures for chemical spills.
The European Centre for the Evaluation of Alternative Methods (ECVAM, now known as EURL ECVAM) conducted validation studies of the suitability of three in vitro methods for identification of substances with the potential to cause human skin corrosion.
- The EpiDerm™ and EPISKIN™ test methods use cultured cells in a three-dimensional matrix that simulates the structure of human skin. The tests measure cell viability following treatment to assess the potential of a test substance to cause dermal corrosion.
- The rat skin transcutaneous electrical resistance assay assesses damage caused by a test substance to intact rat skin by measuring a decrease in electrical resistance.
ECVAM concluded that these methods were able to distinguish between corrosive and noncorrosive substances for all of the classes considered. In 2000, subsequent to the ECVAM recommendation, the European Union accepted these methods for corrosivity testing. ICCVAM based its recommendations on these methods on the ECVAM studies and other available data.
OECD Acceptance of In Vitro Methods for Identification of Potential Skin Corrosives
These in vitro assays are accepted internationally via test guidelines issued by the Organisation for International Co-operation and Development (OECD). Human skin model test methods such as EPISKIN™ and EpiDerm™ are described in OECD Test Guideline 431. The rat skin transcutaneous electrical resistance assay is described in OECD Test Guideline 430.
ICCVAM Background Review Document and Related References
- ICCVAM Background Review Document: EPISKIN™, EpiDerm™, and Rat Skin Transcutaneous Electrical Resistance (TER): In Vitro Test Methods for Assessing the Dermal Corrosivity Potential of Chemicals (August 2001)
- European Centre for the Validation of Alternative Methods (ECVAM): Statement on the Scientific Validity of the EPISKIN™ Test (March 1998)
- INVITTOX Protocol for the EPISKIN™ Test (updated October 2002)