Q3 · MEDICINE
Article
Author: De Jong, Wim H ; Pescio, Paolo ; Briotet, Damien ; Kim, Kwang-Mahn ; Haishima, Yuji ; Meloni, Marisa ; De La Fonteyne, Liset J J ; Turley, Audrey P ; Miyajima, Atsuko ; Rollins, Thor S ; Letasiova, Silvia ; Kandárová, Helena ; Kwon, Jae Sung ; Christiano, Nicholas ; Hofman-Hüther, Hana ; Sawyer, Anita ; Skoog, Shelby ; Parker, Sherry ; Lee, Michelle ; Willoughby, Jamin ; Zdawczyk, Austin ; Bachelor, Michael ; Julius, Conrad ; Fant, Kristina ; Videau, Christelle ; Tornier, Carine ; Kato, Reiko ; Hoffmann, Sebastian ; Pellevoisin, Christian ; Schatz, Timothy ; Coleman, Kelly P ; Gehrke, Helge ; Rollins, Beau
Assessment of skin irritation is an essential component of the safety evaluation of medical devices.OECD Test Guideline 439 describes the use of reconstructed human epidermis (RhE) as an in vitro test system for classification of skin irritation by neat chems.An international round robin study was conducted to evaluate the RhE method for determination of skin irritant potential of medical device extractsFour irritant polymers and three non-irritant controls were obtained or developed that had demonstrated their suitability to act as pos. or neg. test samples.The RhE tissues (EpiDerm and SkinEthic RHE) were dosed with 100μL aliquots of either saline or sesame oil extractIncubation times were 18h (EpiDerm) and 24h (SkinEthic RHE).Cell viability reduction >50% was indicative of skin irritation.Both the EpiDerm and SkinEthic RHE tissues were able to correctly identify virtually all of the irritant polymer samples either in the saline, sesame oil or both solvent extractsThe authors' results indicate that RhE tissue models can detect the presence of strong skin irritants at low levels in dilute medical device polymer extractsTherefore, these models may be suitable replacements for the rabbit skin irritation test to support the biol. evaluation of medical devices.