Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDermâ¢

Article ID	Journal	Published Year	Pages	File Type
8553981	Toxicology in Vitro	2018	30 Pages	PDF

Abstract

We conclude that a modified RhE skin irritation test has the potential to address the skin irritation potential of the medical devices. Standardization and focus on the technical issues is essential for accurate prediction.

Keywords

ET50 SDS Technical Committee EpiDerm RHE SOP DPBS OECD MTT Lactic acid Heptanoic acid Reconstructed human epidermis Reconstructed epidermis ISO Medical devices Skin irritation Management team In vitro test guideline standard operating procedure Sesame oil the Organisation for Economic Co-operation and Development sodium dodecyl sulphate Dulbecco's phosphate buffered saline Vehicle control negative control positive controls

Related Topics

Life Sciences Environmental Science Health, Toxicology and Mutagenesis

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Pre-validation of an in vitro skin irritation test for medical devices using the reconstructed human tissue model EpiDermâ¢

Authors

Kandarova Helena, Willoughby Jamin A., De Jong Wim H., Letasiova Silvia, Milasova Tatiana, Bachelor Michael A., Breyfogle Bridget, Yuki Handa, De la Fonteyne Liset, Coleman Kelly P.,