{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T01:38:42Z","timestamp":1790645922916,"version":"4.1.0"},"reference-count":39,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-017"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-037"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-012"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-029"},{"start":{"date-parts":[[2021,5,1]],"date-time":"2021-05-01T00:00:00Z","timestamp":1619827200000},"content-version":"stm-asf","delay-in-days":0,"URL":"https:\/\/doi.org\/10.15223\/policy-004"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Toxicology Letters"],"published-print":{"date-parts":[[2021,5]]},"DOI":"10.1016\/j.toxlet.2021.01.024","type":"journal-article","created":{"date-parts":[[2021,2,5]],"date-time":"2021-02-05T05:51:04Z","timestamp":1612504264000},"page":"59-67","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":7,"special_numbering":"C","title":["\u2018Site of contact genotoxicity\u2019 assessment for implants - Potential use of single cell gel electrophoresis in biocompatibility testing of medical devices"],"prefix":"10.1016","volume":"341","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9058-6783","authenticated-orcid":false,"given":"T.S.","family":"Kumaravel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"Brabu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Parthiban","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.S.","family":"Murugan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.N.","family":"Jha","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.toxlet.2021.01.024_bib0005","doi-asserted-by":"crossref","first-page":"949","DOI":"10.1007\/s00204-013-1070-0","article-title":"The essential comet assay: a comprehensive guide to measuring DNA damage and repair","volume":"87","author":"Azqueta","year":"2013","journal-title":"Arch. Toxicol."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0010","series-title":"Biomaterials Science, An Introduction to Materials in Medicine.","first-page":"791","article-title":"Systemic and immune toxicity of implanted materials","author":"Barchowsky","year":"2020"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0015","doi-asserted-by":"crossref","first-page":"1037","DOI":"10.1039\/C4TX00198B","article-title":"Biocompatibility studies on lanthanum oxide nanoparticles","volume":"4","author":"Brabu","year":"2015","journal-title":"Toxicol. Res."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0020","doi-asserted-by":"crossref","first-page":"503146","DOI":"10.1016\/j.mrgentox.2020.503146","article-title":"Guidance for publishing comet assay results","volume":"854-855","author":"Brunborg","year":"2020","journal-title":"Mutat. Res."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0025","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1016\/j.mrgentox.2006.08.011","article-title":"Fourth international workgroup on genotoxicity testing: results of the in vivo Comet assay workgroup","volume":"627","author":"Burlinson","year":"2007","journal-title":"Mutat. Res."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0030","doi-asserted-by":"crossref","first-page":"5","DOI":"10.21037\/aoj.2019.10.01","article-title":"Local and systemic consequences of metal-on-metal hip resurfacing implants","volume":"5","author":"Campbell","year":"2020","journal-title":"Ann. Jt."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0035","doi-asserted-by":"crossref","first-page":"152","DOI":"10.2106\/00004623-195941010-00018","article-title":"Assay of foreign-body reaction","volume":"41A","author":"Cohen","year":"1959","journal-title":"J. Bone Jt. Surg."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0040","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1093\/mutage\/geu079","article-title":"The comet assay: a heavenly method!","volume":"30","author":"Collins","year":"2015","journal-title":"Mutagenesis"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0045","unstructured":"Comet assay interest group. www.cometassay.com. Accessed 25 Jul 2020."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0050","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1016\/j.pnpbp.2017.06.036","article-title":"The interplay between inflammation, oxidative stress, DNA damage, DNA repair and mitochondrial dysfunction in depression","volume":"80","author":"Czarny","year":"2018","journal-title":"Prog. Neuropsychopharmacol. Biol. Psychiatry"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0055","doi-asserted-by":"crossref","first-page":"1292","DOI":"10.1080\/15287394.2014.935540","article-title":"Genotoxicity and DNA repair processes of zinc oxide nanoparticles","volume":"77","author":"Demir","year":"2014","journal-title":"J. Toxicol. Environ. Health A"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0060","doi-asserted-by":"crossref","first-page":"535","DOI":"10.1016\/j.cpm.2019.06.001","article-title":"Implantable materials update","volume":"36","author":"Dux","year":"2019","journal-title":"Clin. Podiatr. Med. Surg."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0065","doi-asserted-by":"crossref","first-page":"e05708","DOI":"10.2903\/j.efsa.2019.5708","article-title":"Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment","volume":"17","author":"EFSA Scientific Committee","year":"2019","journal-title":"EFSA J."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0070","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1016\/j.mrgentox.2011.12.003","article-title":"Characterization of synthesized silver nanoparticles and assessment of its genotoxicity potentials using the alkaline comet assay","volume":"742","author":"Flower","year":"2012","journal-title":"Mutat. Res."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0075","series-title":"Biomaterials, Medical Devices, and Combination Products: Biocompatibility Testing and Safety Assessment Hardcover","author":"Gad","year":"2016"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0080","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1016\/j.toxlet.2009.03.016","article-title":"Literature review on the genotoxicity, reproductive toxicity, and carcinogenicity of ethyl methanesulfonate","volume":"190","author":"Gocke","year":"2009","journal-title":"Toxicol. Lett."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0085","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1002\/em.21863","article-title":"Evaluation of the Pig-a, micronucleus, and comet assay endpoints in a 28-day study with ethyl methanesulfonate","volume":"55","author":"Gunther","year":"2014","journal-title":"Environ. Mol. Mutagen."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0090","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1093\/mutage\/18.1.45","article-title":"Recommendations for conducting the in vivo alkaline Comet assay. 4th international comet assay workshop","volume":"18","author":"Hartmann","year":"2003","journal-title":"Mutagenesis"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0095","series-title":"Biological Evaluation of Medical Devices \u2013 Part 17, Establishment of Allowable Limits for Leachable Substances","author":"ISO","year":"2002"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0100","series-title":"Biological Evaluation of Medical Devices \u2013 Part 5, Tests for in Vitro Cytotoxicity","author":"ISO","year":"2009"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0105","series-title":"Biological Evaluation of Medical Devices \u2013 Part 12, Sample Preparation and Reference Materials","author":"ISO","year":"2012"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0110","series-title":"Biological Evaluation of Medical Devices \u2013 Part 3, Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity","author":"ISO","year":"2014"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0115","series-title":"Biological Evaluation of Medical Devices \u2013 Part 33, Guidance on Tests to Evaluate Genotoxicity - Supplement to ISO 10993-3","author":"ISO","year":"2015"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0120","series-title":"Biological Evaluation of Medical Devices \u2013 Part 6, Tests for Local Effects After Implantation","author":"ISO","year":"2016"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0125","series-title":"Biological Evaluation of Medical Devices \u2013 Part 1, Evaluation and Testing Within a Risk Management Process","author":"ISO","year":"2018"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0130","series-title":"Biological Evaluation of Medical Devices \u2013 Part 18, Chemical Characterization of Medical Device Materials Within a Risk Management Process","author":"ISO","year":"2020"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0135","series-title":"Biological Evaluation of Medical Devices \u2014 Application of the Threshold of Toxicological Concern (TTC) for Assessing Biocompatibility of Medical Device Constituents","author":"ISO\/TS","year":"2019"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0140","doi-asserted-by":"crossref","first-page":"25","DOI":"10.1039\/C8TX00248G","article-title":"Biocompatibility studies on cerium oxide nanoparticles \u2013 combined study for local effects, systemic toxicity and genotoxicity via implantation route","volume":"8","author":"Kalyanaraman","year":"2019","journal-title":"Toxicol. Res."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0145","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1016\/j.mrgentox.2006.03.002","article-title":"Reliable Comet assay measurements for detecting DNA damage induced by ionising radiation and chemicals","volume":"605","author":"Kumaravel","year":"2006","journal-title":"Mutat. Res."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0150","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1016\/j.mrrev.2014.09.001","article-title":"Oxidative stress and inflammation generated DNA damage by exposure to air pollution particles","volume":"762","author":"M\u00f8ller","year":"2014","journal-title":"Mutat. Res. Rev. Mutat. Res."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0155","series-title":"Integrated Safety and Risk Assessment for Medical Devices and Combination Products","first-page":"441","article-title":"Toxicity of Common extractables and leachables of medical devices","author":"Nappier","year":"2019"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0160","series-title":"Implantable Sensor Systems for Medical Applications, A Volume in Woodhead Publishing Series in Biomaterials","first-page":"3","article-title":"Materials for implantable systems","author":"Neves","year":"2013"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0165","series-title":"Guidelines for the Testing of Chemicals, Section 4 \u2013 Health Effects. Test No. 489: in Vivo Mammalian Alkaline Comet Assay","author":"OECD","year":"2016"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0170","series-title":"Guidelines for the Testing of Chemicals, Section 4 \u2013 Health Effects. Test No. 473: in Vitro Mammalian Chromosomal Aberration Test","author":"OECD","year":"2016"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0175","series-title":"Guidelines for the Testing of Chemicals, Section 4 \u2013 Health Effects. Test No. 471: Bacterial Reverse Mutation Test","author":"OECD","year":"2020"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0180","doi-asserted-by":"crossref","first-page":"780","DOI":"10.1016\/j.jpba.2007.11.013","article-title":"Development and validation of GC\u2013MS method for the determination of methyl methanesulfonate and ethyl methanesulfonate in imatinib mesylate","volume":"46","author":"Ramakrishna","year":"2008","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0185","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1016\/0165-1110(84)90007-1","article-title":"A review of the genetic effects of ethyl methanesulfonate","volume":"134","author":"Sega","year":"1984","journal-title":"Mutat. Res. Rev. Genet. Toxicol."},{"key":"10.1016\/j.toxlet.2021.01.024_bib0190","author":"U.S. Department of health and human services","year":"2016"},{"key":"10.1016\/j.toxlet.2021.01.024_bib0195","series-title":"Center for Devices and Radiological Health. Biological Responses to Metal Implants","author":"U.S. Food and drug administration","year":"2019"}],"container-title":["Toxicology Letters"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0378427421000333?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0378427421000333?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T05:22:00Z","timestamp":1759900920000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0378427421000333"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5]]},"references-count":39,"alternative-id":["S0378427421000333"],"URL":"https:\/\/doi.org\/10.1016\/j.toxlet.2021.01.024","relation":{},"ISSN":["0378-4274"],"issn-type":[{"value":"0378-4274","type":"print"}],"subject":[],"published":{"date-parts":[[2021,5]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"\u2018Site of contact genotoxicity\u2019 assessment for implants - Potential use of single cell gel electrophoresis in biocompatibility testing of medical devices","name":"articletitle","label":"Article Title"},{"value":"Toxicology Letters","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.toxlet.2021.01.024","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2021 Elsevier B.V. All rights reserved.","name":"copyright","label":"Copyright"}]}}