Skin Irritation

Download a printable version of this document here (A4 or 8.5×11).

IN VITRO METHODS FOR PREDICTING SKIN IRRITATION AND CORROSION

MethodPrinciple of the TestRHE Model (If Applicable)Applicability DomainGHS Categorisation
OECD TG 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test MethodTest substance is applied to a 3-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)
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 MethodTest substance is applied topically to a 3-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 CorrosionTest 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/AApplicable 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.

References