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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. It...
In the present study, three laboratories independently compared percutaneous absorption and distribution of 4-n-butylresorcinol, using human skin from five donors. Each laboratory used the same protocol for percutaneous absorption studies but different LC–MS/MS analytical methods to quantify the test compound. All laboratories respected the mass balance criteria (i.e. 100±15%; average 96.5–102% of...
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