Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8554000 | Toxicology in Vitro | 2018 | 24 Pages |
Abstract
Several irritants were used in the in vitro irritation medical device round robin. The objective of this study was to verify their irritation potential using the human patch test (HPT), an in vitro assay, and in vivo data. The irritants were lactic acid (LA), heptanoic acid (HA), sodium dodecyl sulfate (SDS), Genapol® X-80 (GP), and Y-4 polymer. Dilute saline and sesame seed oil (SSO) solutions of each were evaluated using a 4 and 18â¯h HPT and the EpiDerm⢠SIT-MD RhE assay; results were then compared to existing rabbit skin irritation test data. Results from the 4â¯h HPT were negative in most cases except for GP and SDS, while the 18â¯h HPT also identified some LA, HA, and GP samples as irritants. EpiDerm⢠SIT-MD correctly identified all irritants except GP in SSO due to limited solubility. Data from cutaneous rabbit irritation tests were negative, while all intracutaneous results were strongly or weakly positive except for the most dilute GP solutions. These findings indicate that EpiDerm⢠SIT-MD results correlate with those from the rabbit intracutaneous test and confirm that RhE assays are suitable replacements for animals in evaluating the tissue irritation potential of medical devices.
Keywords
Non-irritantMDSSDSDPBSSOPRHEMTTv/vw/vLactic acidHeptanoic acidReconstructed human epidermisISOMedical devicesSkin irritationIrritantvolume/volumestandard operating procedureInternational Organization for Standardizationsodium dodecyl sulfateDulbecco's phosphate buffered salineweight/volumeoptical densityVehicle controlPositive controlnegative control
Related Topics
Life Sciences
Environmental Science
Health, Toxicology and Mutagenesis
Authors
Helena Kandárová, Hana Bendova, Silvia Letasiova, Kelly P. Coleman, Wim H. De Jong, Dagmar JÃrova,