EpiDerm™ In Vitro Dermal Corrosion Measurement
- Organotypic In Vitro Test Method Approved for Assessing Dermal Corrosivity by Both U.S. and European Regulators (Details)
- Cited By Dow Chemical Company as Having “Near-Perfect” in vivo-to-in vitro Concordance at Society of Toxicology 2007 Annual Meeting (Details)
- Guaranteed Reproducibility Based on 15 Years of Production Data (Details)
The EpiDerm Dermal Corrosion Measurement System, formally validated by both U.S. and EU regulators as a replacement for the Draize Rabbit Skin Test, predicts the skin corrosivity potential of a chemical using MatTek's EpiDerm in vitro human skin tissue equivalent, a three dimensional human epidermis model. The test is based on the well-documented fact that corrosive chemicals are cytotoxic to the stratum corneum of the epidermis after a short term exposure.
The potential for chemically-induced dermal corrosion<small>1</small> is an important consideration in establishing procedures for the safe handling, packing and transport of chemicals. Historically, dermal corrosion has been determined using the Draize Rabbit Skin Test.
The transition from in vivo methods (live rabbits) to validated in vitro methods to test chemicals for their dermal corrosivity is well underway. As part of this effort, chemical companies are correlating their historical in vivo test data with the EpiDerm Dermal Corrosion Measurement System. A recent example is the EpiDerm testing done by Dow Chemical Company, results of which were presented at the Society of Toxicology 2007 Annual Meeting. To quote from the Dow Chemical abstract, "In conclusion, EpiDerm™ gave near-perfect concordance with in vivo corrosivity data." (Click on this link to view the Dow abstract.)
EpiDerm Dermal Corrosion Test Overview
The test consists of topical application of the test material to the EpiDerm tissue for (a) 3 minutes and (b) 60 minutes, followed by immediate determination of the cytotoxic effect. Cytotoxicity is expressed using the widely accepted MTT ET-50 Tissue Viability Assay.
A detailed EpiDerm Dermal Corrosivity test protocol is available--please contact MatTek to receive a copy.
Below are histology slides of EpiDerm tissues treated with a negative control (distilled water) and a positive control (KOH) at the 2 time points in the dermal corrosivity protocol (3 minutes and 60 minutes).
Relevant Government Publications include:
ICCVAM Evaluation of EpiDerm™ (EPI-200): In Vitro Test Methods for Assessing Dermal Corrosivity Potential of Chemicals (NIH Pub. #02-4502)
U.S. Federal Register Citation
(Vol. 67, No. 147 / Wednesday, July 31, 2002 / Notices)
ECVAM - EpiDerm Approval Statement
ECVAM - EpiDerm Skin Corrosivity Test Protocol
In an August 2005 OECD publication, EpiDerm “performance…(using data of 3 min and 1 hr) was regarded as excellent as the measures exceeded the predefined acceptance criteria of the best possible outcome…”<small>2</small>
MatTek's highly reproducible EpiDerm System, in production for 15 years, consists of normal (non-transformed), human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. Also known generically as reconstructed human epidermis (RhE), EpiDerm has organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts and shipped world-wide as kits, containing 24 tissues on shipping agarose (Model EPI-200-CORR). Major companies on the EpiDerm user list include Clairol, Dow Chemical, Johnson & Johnson, Procter & Gamble, Revlon, SmithKline Beecham and Unilever.
EpiDerm Dermal Corrosion Technical References
Clicking on the link below will open a page that contains links to a number of technical references describing the development, characterization, and use of this innovative human dermal corrosion measurement system. (Click on the TR number highlighted in blue to review that technical reference.)
Link to ALL EpiDerm Dermal Corrosion Technical References
Key technical references (TR's) within that group include:
TR-461 - IN VITRO SKIN CORROSION TEST: LONG TERM REPRODUCIBILITY AND RELIABILITY FOR A REGULATORY ACCEPTED METHOD
TR-435 - COMPARISON OF CORROSITEX AND EPIDERM IN VITRO SKIN CORROSION SCREENING ASSAYS TO IN VIVO CORROSIVITY RESULTS
TR-237 - DEVELOPMENT OF AN IN VITRO METHOD FOR SKIN CORROSION TESTING
Extensive List of Materials Tested
Click on the link below to view representative list of the materials MatTek and others have tested using the EpiDerm tissue model.
Materials Tested using EpiDerm
Contact MatTek today to learn more about the EpiDerm In Vitro Dermal Corrosion Measurement System.
EpiDerm Reconstructed Human Epidermis (RhE) Data Sheet
EpiDerm Product Specifications
EpiDerm Technical References
1. Dermal Corrosion is generally defined as "the production of scarring usually as result of corrosive tissue destruction (necrosis) following the application of a substance". According to the majority of regulatory classification schemes used internationally, corrosion is defined as "full thickness destruction". Some regulations extend the definition to irreversible alterations of the skin.
Anon (1995). ECETOC Report No. 66: Skin Irritation and Corrosion: Chemicals reference data bank European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels, Belgium
2. “Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment”, OECD Environment, Health and Safety Publications Series on Test and Assessment, No. 34, 18 August 2005, ENV/JM/MONO(2005)14.