{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T18:03:52Z","timestamp":1760551432929},"reference-count":37,"publisher":"Japanese Society of Toxicology","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Toxicol. Sci."],"published-print":{"date-parts":[[2021]]},"DOI":"10.2131\/jts.46.235","type":"journal-article","created":{"date-parts":[[2021,4,30]],"date-time":"2021-04-30T22:14:30Z","timestamp":1619820870000},"page":"235-248","source":"Crossref","is-referenced-by-count":1,"title":["Enhancing between-facility reproducibility of the SH test as an &lt;i&gt;in vitro&lt;\/i&gt; skin sensitization test by the improved test method"],"prefix":"10.2131","volume":"46","author":[{"given":"Noriyasu","family":"Imai","sequence":"first","affiliation":[{"name":"Safety and Analytical Research Laboratories, KOS\u00c9 Corporation"},{"name":"Graduate School of Environment and Information Sciences, Yokohama National University"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Midori","family":"Takeyoshi","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories, KOS\u00c9 Corporation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sakiko","family":"Aizawa","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories, KOS\u00c9 Corporation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mika","family":"Tsurumaki","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories, KOS\u00c9 Corporation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaharu","family":"Kurosawa","sequence":"additional","affiliation":[{"name":"Safety and Analytical Research Laboratories, KOS\u00c9 Corporation"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akemi","family":"Toyoda","sequence":"additional","affiliation":[{"name":"Frontier Research Center, POLA Chemical Industries, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maki","family":"Sugiyama","sequence":"additional","affiliation":[{"name":"Frontier Research Center, POLA Chemical Industries, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaoru","family":"Kasahara","sequence":"additional","affiliation":[{"name":"Frontier Research Center, POLA Chemical Industries, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morihiko","family":"Hirota","sequence":"additional","affiliation":[{"name":"Shiseido Global Innovation Center"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinichi","family":"Ogata","sequence":"additional","affiliation":[{"name":"Graduate School of Environment and Information Sciences, Yokohama National University"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"898","reference":[{"key":"1","doi-asserted-by":"crossref","unstructured":"Adler, S., Basketter, D., Creton, S., Pelkonen, O., van Benthem, J., Zuang, V., Andersen, K. E., Angers-Loustau, A., Aptula, A., Bal-Price, A., Benfenati, E., Bernauer, U., Bessems, J., Bois, F.Y., Boobis, A., Brandon, E., Bremer, S., Broschard, T., Casati, S., Coecke, S., Corvi, R., Cronin, M., Daston, G., Dekant, W., Felter, S., Grignard, E., Gundert-Remy, U., Heinonen, T., Kimber, I., Kleinjans, J., Komulainen, H., Kreiling, R., Kreysa, J., Batista, Leite, S., Loizou, G., Maxwell, G., Mazzatorta, P., Munn, S., Pfuhler, S., Phrakonkham, P., Piersma, A., Poth, A., Prieto, P., Repetto, G., Rogiers, V., Schoeters, G., Schwarz, M., Serafimova, R., T\u00e4hti, H., Testai, E., van Delft, J., van Loveren, H., Vinken, M., Worth, A. and Zaldivar, J.M. (2011): Alternative (non-animal) methods for cosmetics testing: current status and future prospects-2010. Arch. Toxicol., <b>85<\/b>, 367-485.","DOI":"10.1007\/s00204-011-0693-2"},{"key":"2","doi-asserted-by":"crossref","unstructured":"Aiba, S., Manome, H., Nakagawa, S., Mollah, Z.U., Mizuashi, M., Ohtani, T., Yoshino, Y. and Tagami, H. (2003): p38 Mitogen-activated protein kinase and extracellular signal-regulated kinases play distinct roles in the activation of dendritic cells by two representative haptens, NiCl<sub>2<\/sub> and 2,4-dinitrochlorobenzene. J. Invest. Dermatol., <b>120<\/b>, 390-399.","DOI":"10.1046\/j.1523-1747.2003.12065.x"},{"key":"3","doi-asserted-by":"crossref","unstructured":"Ashikaga, T., Yoshida, Y., Hirota, M., Yoneyama, K., Itagaki, H., Sakaguchi, H., Miyazawa, M., Ito, Y., Suzuki, H. and Toyoda, H. (2006): Development of an <i>in vitro<\/i> skin sensitization test using human cell lines: the human Cell Line Activation Test (h-CLAT). I. Optimization of the h-CLAT protocol. Toxicol. In Vitro, <b>20<\/b>, 767-773.","DOI":"10.1016\/j.tiv.2005.10.012"},{"key":"4","unstructured":"Council of the European Union and European Parliament. (2003): Directive 2003\/15\/EC of the European Parliament and of the council of 27 February 2003 amending Council Directive 76\/768\/EEC on the approximation of the laws of the Member States relating to cosmetic products. Official Journal, <b>L66<\/b>, 26-35."},{"key":"5","doi-asserted-by":"crossref","unstructured":"dos Santos, G.G., Reinders, J., Ouwehand, K., Rustemeyer, T., Scheper, R.J. and Gibbs, S. (2009): Progress on the development of human <i>in vitro<\/i> dendritic cell based assays for assessment of the sensitizing potential of a compound. Toxicol. Appl. Pharmacol., <b>236<\/b>, 372-382.","DOI":"10.1016\/j.taap.2009.02.004"},{"key":"6","unstructured":"ESAC. (2016): ESAC opinion on the BASF-coordinated performance ptandards-based validation of the LuSens test method for skin sensitisation testing, Publications Office of the European Union."},{"key":"7","unstructured":"EURL-ECVAM. (2013): EC EURL-ECVAM recommendation on the Direct Peptide Reactivity Assay (DPRA) for the skin sensitisation testing. Publications Office of the European Union."},{"key":"8","unstructured":"EURL-ECVAM. (2014): EURL-ECVAM recommendation on the KeratinoSens<sup>TM<\/sup> assay for skin sensitisation testing. Publications Office of the European Union."},{"key":"9","doi-asserted-by":"crossref","unstructured":"Fujita, M., Yamamoto, Y., Tahara, H., Kasahara, T., Jimbo, Y. and Hioki, T. (2014): Development of a prediction method for skin sensitization using novel cysteine and lysine derivatives. J. Pharmacol. Toxicol. Methods, <b>70<\/b>, 94-105.","DOI":"10.1016\/j.vascn.2014.06.001"},{"key":"10","doi-asserted-by":"crossref","unstructured":"Gerberick, G.F., Vassallo, J.D., Bailey, R.E., Chaney, J.G., Morrall, S.W. and Lepoittevin, J.P. (2004): Development of a peptide reactivity assay for screening contact allergens. Toxicol. Sci., <b>81<\/b>, 332-343.","DOI":"10.1093\/toxsci\/kfh213"},{"key":"11","doi-asserted-by":"crossref","unstructured":"Gerberick, G.F., Vassallo, J.D., Foertsch, L.M., Price, B.B., Chaney, J.G. and Lepoittevin, J.P. (2007): Quantification of chemical peptide reactivity for screening contact allergens: a classification tree model approach. Toxicol. Sci., <b>97<\/b>, 417-427.","DOI":"10.1093\/toxsci\/kfm064"},{"key":"12","doi-asserted-by":"crossref","unstructured":"Hirota, M., Fukui, S., Okamoto, K., Kurotani, S., Imai, N., Fujishiro, M., Kyotani, D., Kato, Y., Kasahara, T., Fujita, M., Toyoda, A., Sekiya, D., Watanabe, S., Seto, H., Takenouchi, O., Ashikaga, T. and Miyazawa, M. (2015): Evaluation of combinations of <i>in vitro<\/i> sensitization test descriptors for the artificial neural network-based risk assessment model of skin sensitization. J. Appl. Toxicol., <b>35<\/b>, 1333-1347.","DOI":"10.1002\/jat.3105"},{"key":"13","doi-asserted-by":"crossref","unstructured":"Hirota, M., Kouzuki, H., Ashikaga, T., Sono, S., Tsujita, K., Sasa, H. and Aiba, S. (2013): Artificial neural network analysis of data from multiple <i>in vitro<\/i> assays for prediction of skin sensitization potency of chemicals. Toxicol. In Vitro, <b>27<\/b>, 1233-1246.","DOI":"10.1016\/j.tiv.2013.02.013"},{"key":"14","doi-asserted-by":"crossref","unstructured":"Hirota, M., Motoyama, A., Suzuki, M., Yanagi, M., Kitagaki, M., Kouzuki, H., Hagino, S., Itagaki, H., Sasa, H., Kagatani, S. and Aiba, S. (2010): Changes of cell-surface thiols and intracellular signaling in human monocytic cell line THP-1 treated with diphenylcyclopropenone. J. Toxicol. Sci., <b>35<\/b>, 871-879.","DOI":"10.2131\/jts.35.871"},{"key":"15","doi-asserted-by":"crossref","unstructured":"Hirota, M., Suzuki, M., Hagino, S., Kagatani, S., Sasaki, Y., Aiba, S. and Itagaki, H. (2009): Modification of cell-surface thiols elicits activation of human monocytic cell line THP-1: possible involvement in effect of haptens 2,4-dinitrochlorobenzene and nickel sulfate. J. Toxicol. Sci., <b>34<\/b>, 139-150.","DOI":"10.2131\/jts.34.139"},{"key":"16","unstructured":"ICCVAM. (1999): The murine local lymph lode assay: A test method for assessing the allergic contact dermatitis potential of chemicals\/compounds, The results of an independent peer review evaluation coordinated by the interagency coordinating committee on the validation of alternative methods (ICCVAM) and the national toxicology program interagency center for the evaluation of alternative toxicological methods (NICEATM), NIH Publication No. 99-4494, Research Triangle Park, NC: National Institute of Environmental Health Sciences."},{"key":"17","doi-asserted-by":"crossref","unstructured":"Narita, K., Ishii, Y., Vo, P.T., Nakagawa, F., Ogata, S., Yamashita, K., Kojima, H. and Itagaki, H. (2018): Improvement of human cell line activation test (h-CLAT) using short-time exposure methods for prevention of false-negative results. J. Toxicol. Sci., <b>43<\/b>, 229-240.","DOI":"10.2131\/jts.43.229"},{"key":"18","doi-asserted-by":"crossref","unstructured":"Narita, K., Vo, P.T., Yamamoto, K., Kojima, H. and Itagaki, H. (2017): Preventing false-negatives in the <i>in vitro<\/i> skin sensitization testing of acid anhydrides using interleukin-8 release assays. Toxicol. In Vitro, <b>42<\/b>, 69-75.","DOI":"10.1016\/j.tiv.2017.04.008"},{"key":"19","doi-asserted-by":"crossref","unstructured":"Natsch, A. (2010): The Nrf2-Keap1-ARE toxicity pathway as a cellular sensor for skin sensitizers--functional relevance and a hypothesis on innate reactions to skin sensitizers. Toxicol. Sci., <b>113<\/b>, 284-292.","DOI":"10.1093\/toxsci\/kfp228"},{"key":"20","doi-asserted-by":"crossref","unstructured":"Natsch, A. and Emter, R. (2008): Skin sensitizers induce antioxidant response element dependent genes: application to the <i>in vitro<\/i> testing of the sensitization potential of chemicals. Toxicol. Sci., <b>102<\/b>, 110-119.","DOI":"10.1093\/toxsci\/kfm259"},{"key":"21","unstructured":"OECD. (2010): Test Guideline No. 429. Skin sensitisation: local lymph node assay. In: OECD Guidelines for the Testing of Chemicals), Organisation for Economic Cooperation and Development, Paris."},{"key":"22","unstructured":"OECD. (2012a): The adverse outcome pathway for skin sensitisation initiated by covalent binding to proteins. Part 1: Scientific evidence. In: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"23","unstructured":"OECD. (2012b): The adverse outcome pathway for skin sensitisation initiated by covalent binding to proteins. Part 2: Use of the AOP to develop chemical categories and integrated assessment and testing approaches. In: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"24","unstructured":"OECD. (2015a): Performance standards for assessment of proposed similar or modified <i>in vitro<\/i> skin sensitisation ARE-NRF2 luciferase test methods. In: OECD Environment, Health and Safety Publications: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"25","unstructured":"OECD. (2015b): Performance standards for the assessment of proposed similar or modified <i>in vitro<\/i> reconstructed human epidermis (RhE) test methods for skin irritation testing as described in TG 439. In: OECD Environment, Health and Safety Publications: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"26","unstructured":"OECD. (2016a): Annex I: Case studies to the guidance document on the reporting of defined approaches and individual information sources to be used within integrated approaches to testing and assessment (IATA) for skin sensitisation. In: OECD Environment, Health and Safety Publications: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"27","unstructured":"OECD. (2016b): Guidance document for the reporting of defined approaches and individual information sources to be used within integrated approaches to testing and assessment (IATA) for skin sensitisation. In: OECD Environment, Health and Safety Publications: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"28","unstructured":"OECD. (2016c): Guidance document for the use of adverse outcome pathways in developing integrated approaches to testing and assessment (IATA). In: OECD Environment, Health and Safety Publications: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"29","unstructured":"OECD. (2018a): Test Guideline No. 442D. <i>In vitro<\/i> skin sensitisation assays addressing the key event on keratinocyte activation. In: OECD Guidelines for the Testing of Chemicals), Organisation for Economic Cooperation and Development, Paris."},{"key":"30","unstructured":"OECD. (2018b): Test Guideline No. 442E. <i>In vitro<\/i> skin sensitisation assays addressing the key event on activation of dendritic cells on the adverse outcome pathway for skin sensitisation. In: OECD Guidelines for the Testing of Chemicals), Organisation for Economic Cooperation and Development, Paris."},{"key":"31","unstructured":"OECD. (2019a): Performance standards for the assessment of proposed similar or modified <i>in vitro<\/i> skin sensitisation DPRA and ADRA test methods. In: OECD Environment, Health and Safety Publications: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"32","unstructured":"OECD. (2019b): Report of the peer review panel on the validation of the amino acid derivative reactivity assay (ADRA). In: Series on Testing &amp; Assessment), Organisation for Economic Cooperation and Development, Paris."},{"key":"33","unstructured":"OECD. (2019c): Test Guideline No. 442C. Key-event-based test guideline for <i>In chemico<\/i> skin sensitisation assays addressing the adverse outcome pathway key event on covalent binding to proteins. In: OECD Guidelines for the Testing of Chemicals), Organisation for Economic Cooperation and Development, Paris."},{"key":"34","doi-asserted-by":"crossref","unstructured":"Ramirez, T., Mehling, A., Kolle, S.N., Wruck, C.J., Teubner, W., Eltze, T., Aumann, A., Urbisch, D., van Ravenzwaay, B. and Landsiedel, R. (2014): LuSens: a keratinocyte based ARE reporter gene assay for use in integrated testing strategies for skin sensitization hazard identification. Toxicol. In Vitro, <b>28<\/b>, 1482-1497.","DOI":"10.1016\/j.tiv.2014.08.002"},{"key":"35","unstructured":"Sakaguchi, H., Ashikaga, T., Miyazawa, M., Yoshida, Y., Ito, Y., Yoneyama, K., Hirota, M., Itagaki, H., Toyoda, H. and Suzuki, H. (2006): Development of an <i>in vitro<\/i> skin sensitization test using human cell lines; human Cell Line Activation Test (h-CLAT). II. An inter-laboratory study of the h-CLAT. Toxicol. In Vitro, <b>20<\/b>, 774-784."},{"key":"36","doi-asserted-by":"crossref","unstructured":"Suzuki, M., Hirota, M., Hagino, S., Itagaki, H. and Aiba, S. (2009): Evaluation of changes of cell-surface thiols as a new biomarker for <i>in vitro<\/i> sensitization test. Toxicol. In Vitro, <b>23<\/b>, 687-696.","DOI":"10.1016\/j.tiv.2009.02.002"},{"key":"37","doi-asserted-by":"crossref","unstructured":"Urbisch, D., Mehling, A., Guth, K., Ramirez, T., Honarvar, N., Kolle, S., Landsiedel, R., Jaworska, J., Kern, P.S., Gerberick, F., Natsch, A., Emter, R., Ashikaga, T., Miyazawa, M. and Sakaguchi, H. (2015): Assessing skin sensitization hazard in mice and men using non-animal test methods. Regul. Toxicol. Pharmacol., <b>71<\/b>, 337-351.","DOI":"10.1016\/j.yrtph.2014.12.008"}],"container-title":["The Journal of Toxicological Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/jts\/46\/5\/46_235\/_pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T03:42:49Z","timestamp":1619840569000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.jstage.jst.go.jp\/article\/jts\/46\/5\/46_235\/_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021]]},"references-count":37,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.2131\/jts.46.235","relation":{},"ISSN":["0388-1350","1880-3989"],"issn-type":[{"value":"0388-1350","type":"print"},{"value":"1880-3989","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021]]}}}