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This study explored the utility of epidermal sensitization assay (EpiSensA) to evaluate the sensitization potential of complex and\/or \u201cdifficult to test\u201d chemicals. Assay performance was evaluated by testing a set of 20 test chemicals including 10 methacrylate esters, 5 silicone\u2010based compounds, 3 crop protection formulations, and 2 surfactant mixtures; each had prior in vivo data plus some <jats:italic>in silico<\/jats:italic> and in vitro data. Using the weight of evidence (WoE) assessments by REACH Lead Registrants, 14 of these chemicals were sensitizers and, six were nonsensitizers based on in vivo studies (local lymph node assay [LLNA] and\/or guinea pig studies). The EpiSensA correctly predicted 16\/20 materials with three test materials as false positive and one silane as false negative. This silane, classified as weak sensitizer via LLNA, also gave a \u201cfalse negative\u201d result in the KeratinoSens\u2122 assay. Overall, consistent with prior evaluations, the EpiSensA demonstrated an accuracy level of 80% relative to available in vivo WoE assessments. In addition, potency classification based on the concentration showing positive marker gene expression of EpiSensA was performed. The EpiSensA correctly predicted the potency for all seven sensitizing methacrylates classified as weak potency via LLNA (EC3 \u2265 10%). In summary, EpiSensA could identify dermal sensitization potential of these test substances and mixtures, and continues to show promise as an in vitro alternative method for dermal sensitization.<\/jats:p>","DOI":"10.1002\/jat.4076","type":"journal-article","created":{"date-parts":[[2020,10,30]],"date-time":"2020-10-30T04:38:01Z","timestamp":1604032681000},"page":"915-927","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Characterization of dermal sensitization potential for industrial or agricultural chemicals with EpiSensA"],"prefix":"10.1002","volume":"41","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  Tochigi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew J.","family":"LeBaron","sequence":"additional","affiliation":[{"name":"Toxicology &amp; Environmental Research &amp; Consulting Dow Chemical Company  Midland Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raja S.","family":"Settivari","sequence":"additional","affiliation":[{"name":"Corteva Agriscience, Haskell R&amp;D Center  Newark Delaware USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaaki","family":"Miyazawa","sequence":"additional","affiliation":[{"name":"R&amp;D, Safety Science Research Kao Corporation  Tochigi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary Sue","family":"Marty","sequence":"additional","affiliation":[{"name":"Toxicology &amp; Environmental Research &amp; Consulting Dow Chemical Company  Midland Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hitoshi","family":"Sakaguchi","sequence":"additional","affiliation":[{"name":"R&amp;D, Safety Science Research Kao Corporation  Tochigi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,10,30]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0278-6915(97)00158-0"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/jat.1545"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2012.05.013"},{"key":"e_1_2_7_5_1","unstructured":"Dow Chemical\/MPA. 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