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IN VITRO METHODS FOR PREDICTING SKIN IRRITATION AND CORROSION
| Method | Principle of the Test | RHE Model (If Applicable) | Applicability Domain | GHS Categorisation |
|---|---|---|---|---|
| OECD TG 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method | The test substance is applied to a three-dimensional reconstructed human epidermis (RhE) model. Following exposure and a post-exposure incubation period, the vital dye MTT is added and cell viability determined. Optional histology may also be conducted to gain further information. | ⇨ EpiSkin™ (L’Oréal, France) ⇨ EpiDerm™ (MatTek, US) ⇨ SkinEthic™ (L’Oréal, France) ⇨ LabCyte EPI-MODEL24 (J-TEC, Japan) ⇨ epiCS® (Phenion, Germany) ⇨ Skin+™ (Sterlab, France) ⇨ KeraSkin™ SIT (Biosolution Co, Republic of Korea) | Applicable to solids, semi-solids, liquids, waxes, and mixtures. | Discriminates skin irritants (Cat 2) from substances not classified for skin irritation (No Cat.). Materials that test positive should be tested for skin corrosion (bottom-up approach). |
| OECD TG 431: In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Method | The test substance is applied topically to a three dimensional RhE model. Corrosive chemicals are able to penetrate the tissue and are cytotoxic to cells in the underlying layers. Cell viability is measured using the vital dye MTT. | ⇨ EpiSkin™ (L’Oréal, France) ⇨ EpiDerm™ (MatTek, US) ⇨ SkinEthic™ (L’Oréal, France) ⇨ epiCS® (Phenion, Germany) ⇨ LabCyte EPI-MODEL24 (J-TEC, Japan) | Applicable to solids, semi-solids, liquids, waxes, and mixtures. | Discriminates non-corrosive substances from corrosive substances (Cat 1) and allows subcategorisation into 1A or 1B and 1C together. Materials that test negative should be tested for skin irritation (top-down approach). |
| OECD TG 435: In Vitro Membrane Barrier Test Method for Skin Corrosion | The test substance is applied to the surface of an artificial membrane barrier designed to respond in a manner similar to skin in vivo. The time taken for the test substance to penetrate the barrier predicts corrosivity. | N/A | Applicable to solids, liquids, and emulsions. Aqueous chemicals with a pH in the range of 4.5 to 8.5 may not qualify for testing. | Discriminates non-corrosive substances from corrosive substances and allows full subcategorisation into 1A, 1B, and 1C. |
Additional Reading
- Organisation for Economic Co-operation and Development. 2014. New guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation. Series on Testing and Assessment, No 203.
- European Chemicals Agency. 2017. Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. Version 6.0. See R.7.2.
- PETA Science Consortium International. In vitro methods for skin irritation and corrosion testing. Training tool.