National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/40196

EPISKIN, EpiDerm, and Rat Skin Transcutaneous Electrical Resistance Assay


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)
View PDF of complete report

Background

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.

  • 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 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.

OECD Acceptance of In Vitro Methods for Identification of Potential Skin Corrosives

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)

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)

NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.