{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T03:08:56Z","timestamp":1775012936342,"version":"3.50.1"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,10,28]],"date-time":"2023-10-28T00:00:00Z","timestamp":1698451200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP20mk0101131"],"award-info":[{"award-number":["JP20mk0101131"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["analyticalsciencejournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Applied Toxicology"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The Epidermal Sensitization Assay (EpiSensA) is a reconstructed human epidermis (RhE)\u2010based gene expression assay for predicting the skin sensitization potential of chemicals. Since the RhE model is covered by a stratified stratum corneum, various kinds of test chemicals, including lipophilic ones and pre\u2010\/pro\u2010haptens, can be tested with a route of exposure akin to an in vivo assay and human exposure. This article presents the results of a formally managed validation study of the EpiSensA that was carried out by three participating laboratories. The purpose of this validation study was to assess transferability of the EpiSensA to new laboratories along with its within\u2010 (WLR) and between\u2010laboratory reproducibility (BLR). The validation study was organized into two independent stages. As demonstrated during the first stage, where three sensitizers and one non\u2010sensitizer were correctly predicted by all participating laboratories, the EpiSensA was successfully transferred to all three participating laboratories. For Phase I of the second stage, each participating laboratory performed three experiments with an identical set of 15 coded test chemicals resulting in WLR of 93.3%, 93.3%, and 86.7%, respectively. Furthermore, when the results from the 15 test chemicals were combined with those of the additional 12 chemicals tested in Phase II of the second stage, the BLR for 27 test chemicals was 88.9%. Moreover, the predictive capacity among the three laboratories showed 92.6% sensitivity, 63.0% specificity, 82.7% accuracy, and 77.8% balanced accuracy based on murine local lymph node assay (LLNA) results. Overall, this validation study concluded that EpiSensA is easily transferable and sufficiently robust for assessing the skin sensitization potential of chemicals.<\/jats:p>","DOI":"10.1002\/jat.4559","type":"journal-article","created":{"date-parts":[[2023,10,28]],"date-time":"2023-10-28T05:34:39Z","timestamp":1698471279000},"page":"510-525","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The inter\u2010laboratory validation study of EpiSensA for predicting skin sensitization potential"],"prefix":"10.1002","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8778-1951","authenticated-orcid":false,"given":"Hideyuki","family":"Mizumachi","sequence":"first","affiliation":[{"name":"R&amp;D Safety Science Research Kao Corporation  2606 Akabane, Ichikai\u2010Machi Haga\u2010Gun Tochigi 321\u20103497 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mika","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Food and Drug Safety Center Hatano Research Institute  729\u20105 Ochiai Hadano Kanagawa 257\u20108523 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mayu","family":"Ikezumi","sequence":"additional","affiliation":[{"name":"Food and Drug Safety Center Hatano Research Institute  729\u20105 Ochiai Hadano Kanagawa 257\u20108523 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michika","family":"Kajiwara","sequence":"additional","affiliation":[{"name":"Food and Drug Safety Center Hatano Research Institute  729\u20105 Ochiai Hadano Kanagawa 257\u20108523 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michiyo","family":"Yasuda","sequence":"additional","affiliation":[{"name":"Food and Drug Safety Center Hatano Research Institute  729\u20105 Ochiai Hadano Kanagawa 257\u20108523 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2300-1618","authenticated-orcid":false,"given":"Makoto","family":"Mizuno","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories KOS\u00c9 Corporation  48\u201018 Sakae\u2010cho, Kita\u2010ku Tokyo 114\u20100005 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1488-4292","authenticated-orcid":false,"given":"Noriyasu","family":"Imai","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories KOS\u00c9 Corporation  48\u201018 Sakae\u2010cho, Kita\u2010ku Tokyo 114\u20100005 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Megumi","family":"Sakuma","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories KOS\u00c9 Corporation  48\u201018 Sakae\u2010cho, Kita\u2010ku Tokyo 114\u20100005 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Momoko","family":"Shibata","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories KOS\u00c9 Corporation  48\u201018 Sakae\u2010cho, Kita\u2010ku Tokyo 114\u20100005 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shin\u2010ichi","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Safety Research Science Laboratory LION Corporation  100 Tajima Odawara\u2010shi Kanagawa 256\u20100811 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junko","family":"Motoyama","sequence":"additional","affiliation":[{"name":"Safety Research Science Laboratory LION Corporation  100 Tajima Odawara\u2010shi Kanagawa 256\u20100811 Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Basketter","sequence":"additional","affiliation":[{"name":"DABMEB Consultancy Ltd., Kingswood  Gloucestershire GL12 8RN UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chantra","family":"Eskes","sequence":"additional","affiliation":[{"name":"Services and Consultation on Alternative Methods (SeCAM) Magliaso, Switzerland and Swiss 3R Competence Centre (3RCC)  Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian","family":"Hoffmann","sequence":"additional","affiliation":[{"name":"seh consulting + services  Stembergring 15 Paderborn 33106 Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David M.","family":"Lehmann","sequence":"additional","affiliation":[{"name":"Office of Research and Development US Environmental Protection Agency  109 T.W. 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