Proof of concept testing of a positive reference material for in vivo and in vitro sensitization testing of medical devices

In this study, polyurethane sheets containing 1  wt/wt % 2,4-dinitrochlorobenzene (DNCB-PU) were developed and evaluated as a positive reference material for skin sensitization tests. DNCB-PU sheet extracts prepared with sesame oil elicited positive sensitization responses for in vivo sensitization potential in the guinea pig maximization test and the local lymph node assay. Furthermore, DNCB-PU sheet extracts prepared with water and acetonitrile, 10% fetal bovine serum-containing medium, or sesame oil elicited positive sensitization responses as alternatives to animal testing based on the amino acid derivative reactivity assay, human cel l line activation test, and epidermal sensitization assay, respectively. These data suggest that the DNCB-PU sheet is an effective extractable positive reference material for in vivo and in vitro skin sensitization testing in medical devices. The formulation of this reference material will lead to t he development of safer medical devices that contribute to patient safety.

Source: Journal of Biomedical Materials Research Part B: Applied Biomaterials - February 9, 2024 Category: Materials Science Authors: Yusuke Okamoto, Chie Fukui, Toshio Kobayashi, Hisako Morioka, Hideyuki Mizumachi, Yoriko Inomata, Atsushi Kaneki, Masayuki Okada, Yuji Haishima, Eiichi Yamamoto, Yusuke Nomura Tags: RESEARCH ARTICLE Source Type: research