Show simple item record

dc.contributor.authorKandárová, Helena
dc.contributor.authorBendova, Hana
dc.contributor.authorLetasiova, Silvia
dc.contributor.authorColeman, Kelly P
dc.contributor.authorDe Jong, Wim H
dc.contributor.authorJírova, Dagmar
dc.date.accessioned2018-02-27T13:46:13Z
dc.date.available2018-02-27T13:46:13Z
dc.date.issued2018-02-17
dc.identifier.citationEvaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol. 2018 Toxicol In Vitroen
dc.identifier.issn1879-3177
dc.identifier.pmid29462660
dc.identifier.doi10.1016/j.tiv.2018.02.009
dc.identifier.urihttp://hdl.handle.net/10029/621461
dc.description.abstractSeveral 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 18 h HPT and the EpiDerm™ SIT-MD RhE assay; results were then compared to existing rabbit skin irritation test data. Results from the 4 h HPT were negative in most cases except for GP and SDS, while the 18 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.
dc.language.isoenen
dc.titleEvaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol.en
dc.typeArticleen
dc.identifier.journalToxicol in Vitro 2018; advance online publication (ahead of print)en
html.description.abstractSeveral 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 18 h HPT and the EpiDerm™ SIT-MD RhE assay; results were then compared to existing rabbit skin irritation test data. Results from the 4 h HPT were negative in most cases except for GP and SDS, while the 18 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.


Files in this item

Thumbnail
Name:
Publisher version

This item appears in the following Collection(s)

Show simple item record