Human 3-D Epidermis Model in Vitro Phototoxicity Test

Method Description

The test method is based on the commercially available EpiDerm™ model, a reconstructed human epidermal (RhE) model grown from human-derived epidermal keratinocytes, which are cultured to form a multilayered and highly differentiated model of the human epidermis. The SOP has been developed on the basis of the Skin2 test in 1997 and method validation conducted during 1997-1999. A follow-up study has been performed during 2002-2005 to access whether the method can also address the potency of the topically applied photo-toxins. The Phototoxicity of chemicals is assessed by the measurement cytotoxic response of irradiated and non-irradiated RhE model. The method can be used as stand-alone or in combination with OECD TG 432 and other assays depending on the outcomes and regulatory schemes. The test was accepted in 2015 into the ICH Guideline S10 Photosafety evaluation of pharmaceuticals.