Guideline of Alternative Animal Testing Methods for Cosmetics: Phototoxicity Test Using Reconstructed Human Epidermis

This guideline details an in-vitro alternative test method, the Reconstructed Human Epidermis Phototoxicity Test (RhE PT), for identifying the phototoxic potential of substances intended for topical application on the skin. The method assesses the relative reduction in cell viability in a reconstructed human epidermis (RhE) model after exposure to a test substance, with and without irradiation from a simulated solar light source. The guideline includes two validated test methods using commercially available RhE models: EpiDerm™ Phototoxicity Test (PT) and KeraSkin™ Phototoxicity Assay (PA). Cell viability is quantitatively measured using the MTT assay.

Contents

Part I: Summary

1. Overview

2. Test Principle

3. Limitations and Considerations

4. Test Method

5. Acceptance Criteria

6. Result Interpretation and Prediction Model

7. Test Results and Reporting

Part II: Translation (OECD TG 498)

Part III: Original Text