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EpiDerm™ (EPI-200) and EPISKIN™ are three-dimensional reconstructed human skin models
that use cell viability as a measure of corrosivity following topical exposure of
a test substance. In the
rat skin transcutaneous electrical resistance assay, corrosive materials are identified by the ability to produce a loss of normal
stratum corneum integrity and barrier function in intact rat skin, which is based on a
reduction of transcutaneous electrical resistance
below a predetermined threshold level.
The European Centre for the Evaluation of Alternative Methods (ECVAM) conducted
validation studies of the suitability of these 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 non-corrosive chemicals
for all of the chemical classes considered. In 2000, subsequent to the ECVAM
recommendation, the European Union accepted these methods for corrosivity testing.
In 2001, ICCVAM conducted an evaluation of the ECVAM studies and all other available
data on these assays, and recommended that they may be used for assessing the dermal
corrosion potential of chemicals in a weight-of-evidence approach in an integrated
testing scheme. In this approach, positive in vitro corrosivity responses do not
generally require further testing and can be used for classification and labeling.
OECD Guidelines for the Testing of Chemicals
In vitro human skin model test methods such as EPISKIN™ and EpiDerm™
are accepted internationally via OECD Test Guideline 431
View on OECD website
The rat TER test method
is accepted internationally via OECD Test Guideline 430
View on OECD website
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)
View report table of contents as webpage
EPISKIN™, EpiDerm™, and Rat Skin Transcutaneous
Electrical Resistance (TER): In Vitro Test Methods for Assessing the Dermal Corrosivity
Potential of Chemicals (August 2001)
Related References
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)
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