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    Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol.

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    Authors
    Kandárová, Helena
    Bendova, Hana
    Letasiova, Silvia
    Coleman, Kelly P
    De Jong, Wim H
    Jírova, Dagmar
    Type
    Article
    Language
    en
    
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    Title
    Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol.
    Published in
    Toxicol in Vitro 2018; advance online publication (ahead of print)
    Publiekssamenvatting
    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 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.
    DOI
    10.1016/j.tiv.2018.02.009
    PMID
    29462660
    URI
    http://hdl.handle.net/10029/621461
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.tiv.2018.02.009
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