Evaluation of the medical devices benchmark materials in the controlled human patch testing and in the RhE in vitro skin irritation protocol
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu časopisecké články
PubMed
29462660
DOI
10.1016/j.tiv.2018.02.009
PII: S0887-2333(18)30046-8
Knihovny.cz E-zdroje
- Klíčová slova
- EpiDerm SIT-MD, Human patch test, ISO 10993-10, Medical devices, Skin irritation,
- MeSH
- alternativy testů na zvířatech MeSH
- benchmarking MeSH
- dodecylsíran sodný toxicita MeSH
- dráždivé látky toxicita MeSH
- králíci MeSH
- kůže účinky léků MeSH
- kyselina mléčná toxicita MeSH
- kyseliny heptylové toxicita MeSH
- lidé MeSH
- náplasťové testy metody MeSH
- polyethylenglykoly toxicita MeSH
- polyvinylchlorid toxicita MeSH
- reprodukovatelnost výsledků MeSH
- testy kožní dráždivosti metody MeSH
- zdravotnické prostředky * MeSH
- zvířata MeSH
- Check Tag
- králíci MeSH
- lidé MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- dodecylsíran sodný MeSH
- dráždivé látky MeSH
- genapol X 080 MeSH Prohlížeč
- kyselina mléčná MeSH
- kyseliny heptylové MeSH
- polyethylenglykoly MeSH
- polyvinylchlorid MeSH
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.
MatTek In vitro Life Science Laboratories Bratislava Slovak Republic
Medtronic Biomaterials Department Minneapolis MN USA
National Institute for Public Health and the Environment Bilthoven The Netherlands
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