ICCVAM has recommended that three in vitro methods may be used for identifying potential dermal corrosives 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 02-4502, June 2002)
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Regulatory agencies require testing to identify dermal corrosives (substances that can cause burns or permanent scarring to the skin). Results of these tests are used to label chemicals 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) conducted validation studies of the suitability of three in vitro methods for identification of substances with the potential to cause human skin corrosion.
ECVAM concluded that these methods were able to distinguish between corrosive and noncorrosive chemicals for all of the chemical 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.
In vitro human skin model test methods such as EPISKIN™ and EpiDerm™ are accepted internationally via OECD Test Guideline 431. The rat TER test method is accepted internationally via OECD Test Guideline 430.
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). 1998. Statement on the Scientific Validity of the EPISKINTM Test
INVITTOX Protocol for the EPISKINTM Test (updated October 2002)