Sensitization potential of medical devices detected by in vitro and in vivo methods

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F75010330%3A_____%2F21%3A00013476" target="_blank" >RIV/75010330:_____/21:00013476 - isvavai.cz</a>

Alternative codes found

RIV/61989592:15110/21:73611175

Result on the web

<a href="https://www.altex.org/index.php/altex/article/view/2017" target="_blank" >https://www.altex.org/index.php/altex/article/view/2017</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.14573/altex.2008142" target="_blank" >10.14573/altex.2008142</a>

Result language

angličtina

Original language name

Sensitization potential of medical devices detected by in vitro and in vivo methods

Original language description

Medical devices must be tested before marketing in accordance with ISO EN 10993-10 in order to avoid skin sensitization. This standard predominantly refers to the in vivo test but does not exclude the use of in vitro methods that have been sufficiently technically and scientifically validated for medical device testing. It is foreseen that, due to the complexity of the sensitization endpoint, a combination of several methods will be needed to address all key events occurring in the sensitization process. The objective of this pilot study was to evaluate the sensitization potential of selected medical devices using a combination of in chemico (DPRA, OECD TG 442C) and in vitro (LuSens, OECD TG 442D) methods in comparison with the in vivo (LLNA DA, OECD TG 442A) method and to suggest a possible testing strategy for the safety assessment of medical device extracts. Overall, one of the 42 tested samples exhibited positive results in all employed test methods, while 33 samples were predicted as non-sensitizing in all three performed methods. This study demonstrated good agreement between in vitro and in vivo results regarding non-sensitizing samples; however, some discrepancies in positive classification were recorded. A testing strategy is suggested in which negative results are accepted and any positive results in the in chemico or in vitro tests are followed up with a third in vitro test and evaluated in accordance with the "2 out of 3 approach". This strategy may reduce and replace animal use for testing the sensitization potential of medical devices.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30108 - Toxicology

Project

<a href="/en/project/EF16_019%2F000860" target="_blank" >EF16_019/000860: International competitiveness of NIPH in research, development and education in alternative toxicological methods.</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2021

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

ALTEX - Alternatives to Animal Experimentation

ISSN

1868-596X

e-ISSN

1868-8551

Volume of the periodical

38

Issue of the periodical within the volume

3

Country of publishing house

DE - GERMANY

Number of pages

12

Pages from-to

419-430

UT code for WoS article

000675218200004

EID of the result in the Scopus database

2-s2.0-85112126966