{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T23:11:33Z","timestamp":1781737893983,"version":"3.54.5"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T00:00:00Z","timestamp":1692835200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T00:00:00Z","timestamp":1692835200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000066","name":"National Institute of Environmental Health Sciences","doi-asserted-by":"publisher","award":["HHSN273201500010C"],"award-info":[{"award-number":["HHSN273201500010C"]}],"id":[{"id":"10.13039\/100000066","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000066","name":"National Institute of Environmental Health Sciences","doi-asserted-by":"publisher","award":["HHSN273201500010C"],"award-info":[{"award-number":["HHSN273201500010C"]}],"id":[{"id":"10.13039\/100000066","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000066","name":"National Institute of Environmental Health Sciences","doi-asserted-by":"publisher","award":["HHSN273201500010C"],"award-info":[{"award-number":["HHSN273201500010C"]}],"id":[{"id":"10.13039\/100000066","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000066","name":"National Institute of Environmental Health Sciences","doi-asserted-by":"publisher","award":["HHSN273201500010C"],"award-info":[{"award-number":["HHSN273201500010C"]}],"id":[{"id":"10.13039\/100000066","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000066","name":"National Institute of Environmental Health Sciences","doi-asserted-by":"publisher","award":["HHSN273201500010C"],"award-info":[{"award-number":["HHSN273201500010C"]}],"id":[{"id":"10.13039\/100000066","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Bundesinstitut f\u00fcr Risikobewertung (BfR)"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arch Toxicol"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Critical to the evaluation of non-animal tests are reference data with which to assess their relevance. Animal data are typically used because they are generally standardized and available. However, when regulatory agencies aim to protect human health, human reference data provide the benefit of not having to account for possible interspecies variability. To support the evaluation of non-animal approaches for skin sensitization assessment, we collected data from 2277 human predictive patch tests (HPPTs), i.e., human repeat insult patch tests and human maximization tests, for skin sensitization from 1555 publications. We recorded protocol elements and positive or negative outcomes, developed a scoring system to evaluate each test for reliability, and calculated traditional and non-traditional dose metrics. We also traced each test result back to its original report to remove duplicates. The resulting database, which contains information for 1366 unique substances, was characterized for physicochemical properties, chemical structure categories, and protein binding mechanisms. This database is publicly available on the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods website and in the Integrated Chemical Environment to serve as a resource for additional evaluation of alternative methods and development of new approach methodologies for skin sensitization assessments.<\/jats:p>","DOI":"10.1007\/s00204-023-03530-3","type":"journal-article","created":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T14:06:33Z","timestamp":1692885993000},"page":"2825-2837","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["A database of human predictive patch test data for skin sensitization"],"prefix":"10.1007","volume":"97","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4112-7484","authenticated-orcid":false,"given":"Judy","family":"Strickland","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8021-0977","authenticated-orcid":false,"given":"Jaleh","family":"Abedini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8575-9547","authenticated-orcid":false,"given":"David G.","family":"Allen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9781-9842","authenticated-orcid":false,"given":"John","family":"Gordon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2650-4392","authenticated-orcid":false,"given":"Victoria","family":"Hull","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7914-3682","authenticated-orcid":false,"given":"Nicole C.","family":"Kleinstreuer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9915-7275","authenticated-orcid":false,"given":"Hon-Sum","family":"Ko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9912-0322","authenticated-orcid":false,"given":"Joanna","family":"Matheson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9655-681X","authenticated-orcid":false,"given":"Hermann-Josef","family":"Thierse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3550-5602","authenticated-orcid":false,"given":"James","family":"Truax","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8900-8209","authenticated-orcid":false,"given":"Jens T.","family":"Vanselow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5636-8152","authenticated-orcid":false,"given":"Matthias","family":"Herzler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,8,24]]},"reference":[{"key":"3530_CR1","doi-asserted-by":"publisher","first-page":"100184","DOI":"10.1016\/j.comtox.2021.100184","volume":"20","author":"JA Abedini","year":"2021","unstructured":"Abedini JA, Cook B, Bell S, Chang X, Choksi N, Daniel AB, Hines D, Karmaus AL, Mansouri K, McAfee E, Phillips J, Rooney J, Sprankle CS, Allen D, Casey W, Kleinstreuer N (2021) Application of new approach methodologies: ICE tools to support chemical evaluations. Comput Toxicol 20:100184. https:\/\/doi.org\/10.1016\/j.comtox.2021.100184","journal-title":"Comput Toxicol"},{"key":"3530_CR2","doi-asserted-by":"publisher","first-page":"452","DOI":"10.1038\/533452a","volume":"533","author":"M Baker","year":"2016","unstructured":"Baker M (2016) 1500 scientists lift the lid on reproducibility. Nature 533:452\u2013454. https:\/\/doi.org\/10.1038\/533452a","journal-title":"Nature"},{"issue":"2","key":"3530_CR3","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1111\/cod.13252","volume":"81","author":"NH Bennike","year":"2019","unstructured":"Bennike NH, Heisterberg MS, White IR, Mahler V, Silvestre-Salvador JF, Gim\u00e9nez-Arnau A, Johansen JD (2019) Quality of life and disease severity in dermatitis patients with fragrance allergy-A cross-sectional European questionnaire study. Contact Derm 81(2):89\u201396. https:\/\/doi.org\/10.1111\/cod.13252","journal-title":"Contact Derm"},{"issue":"4","key":"3530_CR4","doi-asserted-by":"publisher","first-page":"275","DOI":"10.1016\/0278-6915(91)90025-3","volume":"29","author":"PA Botham","year":"1991","unstructured":"Botham PA, Basketter DA, Maurer T, Mueller D, Potokar M, Bontinck WJ (1991) Skin sensitization\u2013a critical review of predictive test methods in animals and man. Food Chem Toxicol 29(4):275\u2013286. https:\/\/doi.org\/10.1016\/0278-6915(91)90025-3","journal-title":"Food Chem Toxicol"},{"key":"3530_CR6","unstructured":"European Chemicals Agency (ECHA) (2022a) REACH\u2013registration, evaluation, authorisation and restriction of chemicals regulation. Registered substances factsheets. Available: https:\/\/echa.europa.eu\/information-on-chemicals\/registered-substances"},{"key":"3530_CR7","doi-asserted-by":"publisher","unstructured":"European Chemicals Agency (ECHA) (2022b) Universe of registered substances. Available: https:\/\/echa.europa.eu\/universe-of-registered-substancesGriffith JF. 1969. Predictive and diagnostic testing for contact sensitization. Toxicol Appl Pharm 14:90\u2013102. https:\/\/doi.org\/10.1016\/S0041-008X(69)80014-1","DOI":"10.1016\/S0041-008X(69)80014-1"},{"key":"3530_CR8","volume-title":"ICCVAM test method evaluation report: usefulness and limitations of the murine local lymph node assay for potency categorization of chemicals causing allergic contact dermatitis in humans","author":"ICCVAM","year":"2011","unstructured":"ICCVAM (2011) ICCVAM test method evaluation report: usefulness and limitations of the murine local lymph node assay for potency categorization of chemicals causing allergic contact dermatitis in humans. National Institute of Environmental Health Sciences. NIH Publication No.11-7709, Research Triangle Park, NC"},{"key":"3530_CR10","doi-asserted-by":"publisher","first-page":"3797536","DOI":"10.1155\/2019\/3797536","volume":"2019","author":"H Kalboussi","year":"2019","unstructured":"Kalboussi H, Kacem I, Aroui H, El Maalel O, Maoua M, Brahem A, El Guedri S, Chatti S, Ghariani N, Mrizak N (2019) Impact of allergic contact dermatitis on the quality of life and work productivity. Dermatol Res Pract 2019:3797536. https:\/\/doi.org\/10.1155\/2019\/3797536","journal-title":"Dermatol Res Pract"},{"issue":"1","key":"3530_CR11","doi-asserted-by":"publisher","first-page":"39","DOI":"10.1016\/j.yrtph.2008.01.010","volume":"52","author":"I Kimber","year":"2008","unstructured":"Kimber I, Dearman RJ, Basketter DA, Ryan CA, Gerberick GF, McNamee PM, Lalko J, Api AM (2008) Dose metrics in the acquisition of skin sensitization: thresholds and importance of dose per unit area. Regul Toxicol Pharmacol 52(1):39\u201345. https:\/\/doi.org\/10.1016\/j.yrtph.2008.01.010","journal-title":"Regul Toxicol Pharmacol"},{"issue":"5","key":"3530_CR13","doi-asserted-by":"publisher","first-page":"393","DOI":"10.1038\/jid.1966.160","volume":"47","author":"AM Kligman","year":"1966","unstructured":"Kligman AM (1966a) The identification of contact allergens by human assay: III. The maximization test: a procedure for screening and rating contact sensitizers. J Invest Dermatol 47(5):393\u2013409","journal-title":"J Invest Dermatol"},{"issue":"5","key":"3530_CR14","doi-asserted-by":"publisher","first-page":"369","DOI":"10.1038\/jid.1966.158","volume":"47","author":"AM Kligman","year":"1966","unstructured":"Kligman AM (1966b) The identification of contact allergens by human assay: I. A critique of standard methods. J Invest Dermatol 47(5):369\u2013374. https:\/\/doi.org\/10.1038\/jid.1966.158","journal-title":"J Invest Dermatol"},{"issue":"5","key":"3530_CR15","doi-asserted-by":"publisher","first-page":"375","DOI":"10.1038\/jid.1966.159","volume":"47","author":"AM Kligman","year":"1966","unstructured":"Kligman AM (1966c) The identification of contact allergens by human assay: II factors influencing the induction and measurement of allergic contact dermatitis. J Invest Dermatol 47(5):375\u2013392. https:\/\/doi.org\/10.1038\/jid.1966.159","journal-title":"J Invest Dermatol"},{"key":"3530_CR17","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1186\/s13321-018-0263-1","volume":"10","author":"K Mansouri","year":"2018","unstructured":"Mansouri K, Grulke CM, Judson RS, Williams AJ (2018) OPERA models for predicting physicochemical properties and environmental fate endpoints. J Cheminform 10:10. https:\/\/doi.org\/10.1186\/s13321-018-0263-1","journal-title":"J Cheminform"},{"issue":"7","key":"3530_CR20","doi-asserted-by":"publisher","first-page":"e0254090","DOI":"10.1371\/journal.pone.0254090","volume":"16","author":"NC Nelson","year":"2021","unstructured":"Nelson NC, Ichikawa K, Chung J, Malik MM (2021) Mapping the discursive dimensions of the reproducibility crisis: a mixed methods analysis. PLoS\u00a0One 16(7):e0254090. https:\/\/doi.org\/10.1371\/journal.pone.0254090","journal-title":"PLoS\u00a0One"},{"key":"3530_CR21","volume-title":"Test No. 406: skin sensitisation; OECD guideline for testing of chemicals; Organisation for economic co-operation and development","author":"OECD","year":"1992","unstructured":"OECD (1992) Test No. 406: skin sensitisation; OECD guideline for testing of chemicals; Organisation for economic co-operation and development. OECD Publishing, Paris"},{"key":"3530_CR22","unstructured":"OECD (2021a) Guideline No. 497; Guideline on defined approaches for skin sensitisation; OECD guidelines for the testing of chemicals; organisation for economic co-operation and development. OECD Publishing, Paris. https:\/\/www.oecd-ilibrary.org\/environment\/guideline-no-497-defined-approaches-on-skin-sensitisation_b92879a4-enn"},{"key":"3530_CR23","unstructured":"OECD (2005) Guidance Document No. 34. Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment: OECD environment, health and safety publications, series on testing and assessment. ENV\/JM\/MONO(2005)10\/14 OECD Publishing, Paris"},{"key":"3530_CR24","doi-asserted-by":"publisher","unstructured":"OECD (2010) Test No. 429: Skin Sensitisation: local lymph node assay; OECD GUIDELINE FOR THE TESTING OF CHEMICALS; Organisation for economic co-operataion and development. OECD publishing: Paris. https:\/\/doi.org\/10.1787\/9789264071100-en","DOI":"10.1787\/9789264071100-en"},{"key":"3530_CR25","unstructured":"OECD (2016) OECD Series on testing and assessment No. 255. Guidance document on the reporting of defined approaches to be used within integrated approaches to testing and assessment. ENV\/JM\/MONO(2016)28. OECD Publishing, Paris"},{"key":"3530_CR26","unstructured":"OECD (2021b) Supporting document to the OECD guideline 497 on defined approaches for skin sensitisation. OECD Publishing, Paris. https:\/\/www.oecd.org\/officialdocuments\/publicdisplaydocumentpdf\/?cote=ENV\/CBC\/MONO(2021a)11&docLanguage=En"},{"key":"3530_CR27","unstructured":"OECD (2021c) The OECD QSAR Toolbox v4.5 [Online]. Paris: OECD. Available: https:\/\/www.oecd.org\/chemicalsafety\/risk-assessment\/oecd-qsar-toolbox.htm"},{"issue":"9","key":"3530_CR28","doi-asserted-by":"publisher","first-page":"1082","DOI":"10.1111\/ijd.15502","volume":"60","author":"OA Olusegun","year":"2021","unstructured":"Olusegun OA, Martincigh BS (2021) Allergic contact dermatitis: a significant environmental and occupational skin disease. Int J Dermatol 60(9):1082\u20131091. https:\/\/doi.org\/10.1111\/ijd.15502","journal-title":"Int J Dermatol"},{"issue":"1","key":"3530_CR29","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1016\/j.yrtph.2007.11.004","volume":"52","author":"VT Politano","year":"2008","unstructured":"Politano VT, Api AM (2008) The Research Institute for Fragrance Materials\u2019 human repeated insult patch test protocol. Reg Toxicol Pharmacol 52(1):35\u201338. https:\/\/doi.org\/10.1016\/j.yrtph.2007.11.004","journal-title":"Reg Toxicol Pharmacol"},{"key":"3530_CR30","unstructured":"R Core Team (2021) R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. https:\/\/www.R-project.org\/"},{"issue":"5","key":"3530_CR31","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1034\/j.1600-0536.2000.042005251.x","volume":"42","author":"MK Robinson","year":"2000","unstructured":"Robinson MK, Gerberick GF, Ryan CA, McNamee P, White IR, Basketter DA (2000) The importance of exposure estimation in the assessment of skin sensitization risk. Contact Derm 42(5):251\u2013259. https:\/\/doi.org\/10.1034\/j.1600-0536.2000.042005251.x","journal-title":"Contact Derm"},{"key":"3530_CR32","unstructured":"Scientific Committee on Cosmetic Products and Non-food Products (2000) Opinion concerning the predictive testing of potentially cutaneous sensiting cosmetic ingredients or mixtures of ingredients adopted by the SCCNFP during the 11th plenary session of 17 Feb 2000. https:\/\/ec.europa.eu\/health\/scientific_committees\/consumer_safety\/opinions\/sccnfp_opinions_97_04\/sccp_out102_en.htm"},{"key":"3530_CR35","volume-title":"Globally harmonized system of classification and labelling of chemicals (GHS\/ST\/SG\/AC.10\/30\/Rev.9). Health and environmental hazards","author":"UN","year":"2021","unstructured":"UN (2021) Globally harmonized system of classification and labelling of chemicals (GHS\/ST\/SG\/AC.10\/30\/Rev.9). Health and environmental hazards. United Nations Economic Commission for Europe, New York, NY"},{"key":"3530_CR37","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1186\/s13321-017-0247-6","volume":"9","author":"AJ Williams","year":"2017","unstructured":"Williams AJ, Grulke CM, Edwards J, McEachran AD, Mansouri K, Baker NC, Patlewicz G, Shah I, Wambaugh JF, Judson RS, Richard AM (2017) The CompTox Chemistry Dashboard: a community data resource for environmental chemistry. J Cheminform 9:61. https:\/\/doi.org\/10.1186\/s13321-017-0247-6","journal-title":"J Cheminform"},{"key":"3530_CR38","doi-asserted-by":"publisher","first-page":"510","DOI":"10.1021\/ci500667v","volume":"55","author":"C Yang","year":"2015","unstructured":"Yang C, Tarkhov A, Marusczyk J, Bienfait B, Gasteiger J, Kleinoeder T, Magdziarz T, Sacher O, Schwab CH, Schwoebel J, Terfloth L, Arvidson K, Richard A, Worth A, Rathman J (2015) New publicly available chemical query language, CSRML, to support chemotype representations for application to data mining and modeling. J Chem Inf Model 55:510\u2013528. https:\/\/doi.org\/10.1021\/ci500667v","journal-title":"J Chem Inf Model"},{"key":"3530_CR39","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1016\/j.comtox.2019.01.006","volume":"10","author":"D Yordanova","year":"2019","unstructured":"Yordanova D, Schultz TW, Kuseva C, Tankova K, Ivanova H, Dermen I, Pavlov T, Temelkov S, Chapkanov A, Georgiev M, Gissi A, Sobanski T, Mekenyan OG (2019) Automated and standardized workflows in the OECD QSAR Toolbox. Comput Toxicol 10:89\u2013104. https:\/\/doi.org\/10.1016\/j.comtox.2019.01.006","journal-title":"Comput Toxicol"}],"container-title":["Archives of Toxicology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00204-023-03530-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00204-023-03530-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00204-023-03530-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,15]],"date-time":"2023-09-15T08:04:35Z","timestamp":1694765075000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00204-023-03530-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,24]]},"references-count":30,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["3530"],"URL":"https:\/\/doi.org\/10.1007\/s00204-023-03530-3","relation":{},"ISSN":["0340-5761","1432-0738"],"issn-type":[{"value":"0340-5761","type":"print"},{"value":"1432-0738","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,24]]},"assertion":[{"value":"16 February 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 May 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"24 August 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"DGA, JA, JS, JT, and VH are employed by Inotiv, Inc., which was funded by the National Institute of Environmental Health Sciences for this work. The remaining authors, JG, NCK, HSK, JM, HJT, JTV, and MH, declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}