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The EpiDerm™ in vitro skin corrosivity test demonstrates high accuracy and reproducibility for predicting chemical skin corrosivity. This validated method offers a reliable alternative for regulatory safety assessments.

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Area of Science:

  • Toxicology and Ecotoxicology
  • In Vitro Toxicology
  • Dermatology

Background:

  • Previous ECVAM (European Centre for the Validation of Alternative Methods) validation studies highlighted the need for reliable in vitro skin corrosivity tests.
  • The Skin2™ and EPISKIN™ human skin models showed promise, but the Skin2™ model's production ceased during validation.
  • A need existed to validate another commercially available human skin model, EpiDerm™, for predicting skin corrosivity.

Purpose of the Study:

  • To prevalidate and refine the EpiDerm™ human skin model assay for predicting skin corrosivity.
  • To assess the reproducibility and predictivity of the EpiDerm™ assay according to the ECVAM prevalidation scheme.
  • To develop and validate a prediction model for classifying chemical skin corrosivity using the EpiDerm™ assay.

Main Methods:

  • A simplified EpiDerm™ test protocol was developed, initially using a 3-minute chemical exposure and cytotoxicity endpoint.
  • The protocol was refined through multiple phases, including establishing Standard Operating Procedures (SOPs), acceptance criteria, and quality assurance measures (GLP).
  • A final blind trial involving three laboratories tested 24 chemicals using refined exposure times (3 minutes and 1 hour) and a hierarchical prediction model (PM2).

Main Results:

  • Initial testing with a 3-minute exposure showed low sensitivity (65%) but high specificity (88%).
  • Extended exposure times (1 hour) significantly improved test sensitivity.
  • The final refined protocol and prediction model (PM2) achieved a balanced predictivity of 88% sensitivity and 86% specificity in a blind trial.

Conclusions:

  • The EpiDerm™ skin corrosivity test is a scientifically valid and reproducible in vitro method for predicting skin corrosivity across a wide spectrum of chemicals.
  • The validated test protocol and prediction model meet high predictivity standards, suitable for regulatory use (e.g., Annex V of the EU Dangerous Substances Directive).
  • The EpiDerm™ assay demonstrated excellent performance for classifying various chemical types, including organic and inorganic acids/bases, neutral organics, electrophiles, and phenols.