Intra- and inter-laboratory reproducibility and accuracy of the LuSens assay: A reporter gene-cell line to detect keratinocyte activation by skin sensitizers

Toxicology in Vitro : an International Journal Published in Association with BIBRA
Tzutzuy RamirezRobert Landsiedel

Abstract

Several non-animal methods are now available to address the key events leading to skin sensitization as defined by the adverse outcome pathway. The KeratinoSens assay addresses the cellular event of keratinocyte activation and is a method accepted under OECD TG 442D. In this study, the results of an inter-laboratory evaluation of the "me-too" LuSens assay, a bioassay that uses a human keratinocyte cell line harboring a reporter gene construct composed of the rat antioxidant response element (ARE) of the NADPH:quinone oxidoreductase 1 gene and the luciferase gene, are described. Earlier in-house validation with 74 substances showed an accuracy of 82% in comparison to human data. When used in a battery of non-animal methods, even higher predictivity is achieved. To meet European validation criteria, a multicenter study was conducted in 5 laboratories. The study was divided into two phases, to assess 1) transferability of the method, and 2) reproducibility and accuracy. Phase I was performed by testing 8 non-coded test substances; the results showed a good transferability to naïve laboratories even without on-site training. Phase II was performed with 20 coded test substances (performance standards recommended by OECD, 2015). In t...Continue Reading

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Citations

Apr 18, 2016·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Coralie DumontSilvia Casati
Apr 14, 2016·Chemical Research in Toxicology·Daniel UrbischRobert Landsiedel
Apr 25, 2017·Environmental Sciences Europe·Sarah E CrawfordHarald F Krug
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Aug 6, 2016·Alternatives to Laboratory Animals : ATLA·Ursula G SauerRobert Landsiedel
Aug 21, 2019·Regulatory Toxicology and Pharmacology : RTP·Renato Ivan de ÁvilaMarize Campos Valadares
Jul 7, 2021·Immunology and Allergy Clinics of North America·Itai ChipindaPaul D Siegel
May 26, 2017·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Elodie ClouetPierre-Jacques Ferret

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