Background: We have characterized a new reconstructed full-thickness skin model, T-Skin™, compared to normal human skin (NHS) and evaluated its use in testing anti-aging compounds.
Methods: The structure and layer-specific markers were compared with NHS using histological and immunohistological staining. In anti-aging experiments, T-Skin was exposed to retinol (10 µM) or vitamin C (200 µM) for 5 days, followed by immunohistological staining evaluation.
According to ISO 10993 standards for biocompatibility of medical devices, skin irritation is one of the three toxicological endpoints to be always addressed in a biological risk assessment. This work presents a new protocol to assess this endpoint in vitro rather than in vivo. The protocol was adapted to medical devices extracts from the OECD TG 439 with the SkinEthic™ RHE model as test system.
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