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Pre-validation of S...
Pre-validation of SENS-IS assay for in vitro skin sensitization of medical devices
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- Pellevoisin, C. (författare)
- EPISKIN, Sweden
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- Cottrez, F. (författare)
- ImmunoSearch, France
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- Johansson, Jenny (författare)
- RISE,Certifiering
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- Pedersen, E. (författare)
- RISE
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- Coleman, K. (författare)
- Medtronic plc, USA
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- Groux, H. (författare)
- ImmunoSearch, France
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(creator_code:org_t)
- Elsevier Ltd, 2021
- 2021
- Engelska.
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Ingår i: Toxicology in Vitro. - : Elsevier Ltd. - 0887-2333 .- 1879-3177. ; 71
- Relaterad länk:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- 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.
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- art (ämneskategori)
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