Pre-validation of SENS-IS assay for in vitro skin sensitization of medical devices.

Autor: Pellevoisin C; EPISKIN, 4, rue Alexander Fleming, Lyon, France. Electronic address: cpellevoisin@epiksin.com., Cottrez F; ImmunoSearch, Les Cyclades, Chemin de Camperousse, Grasse, France., Johansson J; RISE Research Institutes of Sweden AB, Borås, Sweden., Pedersen E; RISE Research Institutes of Sweden AB, Borås, Sweden., Coleman K; Medtronic plc, Minneapolis, MN, USA., Groux H; ImmunoSearch, Les Cyclades, Chemin de Camperousse, Grasse, France.
Jazyk: angličtina
Zdroj: Toxicology in vitro : an international journal published in association with BIBRA [Toxicol In Vitro] 2021 Mar; Vol. 71, pp. 105068. Date of Electronic Publication: 2020 Dec 08.
DOI: 10.1016/j.tiv.2020.105068
Abstrakt: According to ISO 10993-1:2018, the skin sensitization potential of all medical devices must be evaluated, and for this endpoint ISO 10993-10:2010 recommends the use of in vivo assays. The goal of the present study was to determine if the in vitro SENS-IS assay could be a suitable alternative to the current in vivo assays. The SENS-IS assay uses the Episkin Large and SkinEthic RHE reconstructed human epidermis models to evaluate marker genes. In our study, the SENS-IS assay correctly identified 13 sensitizers spiked in a non-polar solvent. In a subsequent analysis six medical device silicone samples previously impregnated with sensitizers were extracted with polar and non-polar solvents. The SENS-IS assay correctly identified five of these extracts, while a sixth extract, which contained the weak sensitizer phenyl benzoate, was classified as negative. However, when this extract was concentrated, or a longer exposure time was used, the assay was able to detect phenyl benzoate. The SENS-IS assay was transferred to a naïve laboratory which correctly identified sensitizers in six blinded silicone samples, including the one containing phenyl benzoate. In light of these results, we conclude that the SENS-IS assay is able to correctly identify the presence of sensitizers in medical devices extracts.
(Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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