{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,3]],"date-time":"2025-10-03T13:12:00Z","timestamp":1759497120786},"reference-count":53,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2019,4,1]],"date-time":"2019-04-01T00:00:00Z","timestamp":1554076800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Regulatory Toxicology and Pharmacology"],"published-print":{"date-parts":[[2019,4]]},"DOI":"10.1016\/j.yrtph.2019.01.022","type":"journal-article","created":{"date-parts":[[2019,1,16]],"date-time":"2019-01-16T16:38:23Z","timestamp":1547656703000},"page":"106-112","update-policy":"http:\/\/dx.doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":3,"special_numbering":"C","title":["Consumer protection provided by the European medical device and cosmetic legislation for condoms and lubricants"],"prefix":"10.1016","volume":"103","author":[{"given":"B.","family":"Desmedt","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Vanhamme","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Vanhee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V.","family":"Rogiers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Deconinck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.yrtph.2019.01.022_bib2","series-title":"No 1003\/2014 of 18 September 2014 Amending Annex V to Regulation (EC) No 1223\/2009 of the European Parliament and of the Council on cosmetic products","first-page":"1","author":"Amendment","year":"2014"},{"key":"10.1016\/j.yrtph.2019.01.022_bib12","series-title":"2016\/1198 of 22 July 2016 Amending Annex V to Regulation (EC) No 1223\/2009 of the European Parliament and of the Council on Cosmetic Products","first-page":"22","author":"Amendment","year":"2016"},{"key":"10.1016\/j.yrtph.2019.01.022_bib13","first-page":"1","article-title":"Amending annex V to regulation (EC) No 1223\/2009 of the european parliament and of the council on cosmetic products","author":"Amendment 2017\/1224 of 6 July","year":"2017","journal-title":"Comm Regul"},{"key":"10.1016\/j.yrtph.2019.01.022_bib1","series-title":"SCCS\/1246\/09: opinion on Alkyl (C16, C18, C22) Trimethylammonium Chloride for Other Uses than as a Preservative. COLIPA n\u00b0 P72","first-page":"60","author":"European commission","year":"2009"},{"key":"10.1016\/j.yrtph.2019.01.022_bib3","doi-asserted-by":"crossref","first-page":"512","DOI":"10.1097\/OLQ.0b013e3181644669","article-title":"Mucosal irritation potential of personal lubricants relates to product osmolality as detected by the slug mucosal irritation assay","volume":"35","author":"Adriaens","year":"2008","journal-title":"Sex. Transm. Dis."},{"key":"10.1016\/j.yrtph.2019.01.022_bib4","doi-asserted-by":"crossref","first-page":"1285","DOI":"10.1016\/j.tiv.2008.02.018","article-title":"Successful prevalidation of the slug mucosal irritation test to assess the eye irritation potency of chemicals","volume":"22","author":"Adriaens","year":"2008","journal-title":"Toxicol. Vitro"},{"key":"10.1016\/j.yrtph.2019.01.022_bib5","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1016\/j.tiv.2005.10.002","article-title":"Organotypic human vaginal-ectocervical tissue model for irritation studies of spermicides, microbicides, and feminine-care products","volume":"20","author":"Ayehunie","year":"2006","journal-title":"Toxicol. Vitro"},{"key":"10.1016\/j.yrtph.2019.01.022_bib6","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1159\/000321065","article-title":"Contact sensitization in the anal and genital area","volume":"40","author":"Bauer","year":"2011","journal-title":"Top Appl Mucosa"},{"key":"10.1016\/j.yrtph.2019.01.022_bib7","doi-asserted-by":"crossref","first-page":"375","DOI":"10.1111\/j.1600-0536.1979.tb04908.x","article-title":"Human cutaneous vulvar reactivity to irritants","volume":"5","author":"Britz","year":"1979","journal-title":"Contact Dermatitis"},{"key":"10.1016\/j.yrtph.2019.01.022_bib8","volume":"195\u2013220","author":"Bromide","year":"1997"},{"key":"10.1016\/j.yrtph.2019.01.022_bib9","series-title":"Final Report on the Safety Assessment of Octoxynols","first-page":"59","volume":"23","author":"CIR","year":"2004"},{"key":"10.1016\/j.yrtph.2019.01.022_bib10","first-page":"2965","article-title":"Safety assessment of trimoniums as used in cosmetics","volume":"31","author":"CIR","year":"2012","journal-title":"Int. J. Toxicol."},{"key":"10.1016\/j.yrtph.2019.01.022_bib11","series-title":"Safety Assessment of Nonoxynols as Used in Cosmetics","first-page":"1","author":"CIR","year":"2016"},{"key":"10.1016\/j.yrtph.2019.01.022_bib14","unstructured":"Cosmetic Ingredient Review (CIR). Available online: http:\/\/www.cir-safety.org\/about [Accessed July 2018]."},{"key":"10.1016\/j.yrtph.2019.01.022_bib15","series-title":"Dermal Sensitization Quantitative Risk Assessment ( QRA ) for Fragrance Ingredients","first-page":"1","year":"2006"},{"key":"10.1016\/j.yrtph.2019.01.022_bib16","doi-asserted-by":"crossref","first-page":"82","DOI":"10.1016\/j.jpba.2013.04.020","article-title":"Development and validation of a fast chromatographic method for screening and quantification of legal and illegal skin whitening agents","volume":"83","author":"Desmedt","year":"2013","journal-title":"J. Pharmaceut. Biomed. Anal."},{"key":"10.1016\/j.yrtph.2019.01.022_bib17","doi-asserted-by":"crossref","first-page":"444","DOI":"10.1016\/j.talanta.2014.08.006","article-title":"HS-GC-MS method for the analysis of fragrance allergens in complex cosmetic matrices","volume":"131","author":"Desmedt","year":"2014","journal-title":"Talanta"},{"key":"10.1016\/j.yrtph.2019.01.022_bib18","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/j.jpba.2013.11.024","article-title":"Characterization of suspected illegal skin whitening cosmetics","volume":"90","author":"Desmedt","year":"2014","journal-title":"J. Pharmaceut. Biomed. Anal."},{"key":"10.1016\/j.yrtph.2019.01.022_bib19","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1097\/01.OLQ.0000118422.62336.FA","article-title":"The evaluation of the local tolerance of vaginal formulations, with or without nonoxynol-9, using the slug mucosal irritation test","volume":"31","author":"Dhondt","year":"2004","journal-title":"Sex. Transm. Dis."},{"key":"10.1016\/j.yrtph.2019.01.022_bib20","doi-asserted-by":"crossref","first-page":"159","DOI":"10.1111\/cod.12871","article-title":"Erythema of the penis after use of a latex condom \u2013 latex allergy or something else","volume":"78","author":"Dittmar","year":"2018","journal-title":"Contact Dermatitis"},{"key":"10.1016\/j.yrtph.2019.01.022_bib21","series-title":"Guidance on the Application of the CLP Criteria, Guidance to Regulation (EC) No 1272\/2008 on Classification, Labelling and Packaging (CLP) of Substances and Mixtures","first-page":"1","author":"ECHA","year":"2017"},{"key":"10.1016\/j.yrtph.2019.01.022_bib22","series-title":"The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients","author":"European Commission","year":"2016"},{"key":"10.1016\/j.yrtph.2019.01.022_bib23","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1007\/s00404-005-0732-4","article-title":"Vulvar susceptibility to contact irritants and allergens: a review","volume":"272","author":"Farage","year":"2005","journal-title":"Arch. Gynecol. Obstet."},{"key":"10.1016\/j.yrtph.2019.01.022_bib24","doi-asserted-by":"crossref","first-page":"201","DOI":"10.1111\/j.0105-1873.2004.00444.x","article-title":"The vulvar epithelium differs from the skin: implications for cutaneous testing to address topical vulvar exposures","volume":"51","author":"Farage","year":"2004","journal-title":"Contact Dermatitis"},{"key":"10.1016\/j.yrtph.2019.01.022_bib25","doi-asserted-by":"crossref","first-page":"140","DOI":"10.1111\/j.0105-1873.2003.00192.x","article-title":"Quantitative risk assessment for the induction of allergic contact dermatitis: uncertainty factors for mucosal exposures","volume":"49","author":"Farage","year":"2003","journal-title":"Contact Dermatitis"},{"key":"10.1016\/j.yrtph.2019.01.022_bib26","first-page":"25","volume":"3","author":"FDA, Code of Federal Regulations","year":"2015"},{"key":"10.1016\/j.yrtph.2019.01.022_bib27","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1016\/j.ad.2011.07.023","article-title":"Allergic contact dermatitis to benzocaine: the importance of concomitant positive patch test results","volume":"104","author":"Gonz\u00e1lez-Rodr\u00edguez","year":"2013","journal-title":"Actas Dermosifiliogr"},{"key":"10.1016\/j.yrtph.2019.01.022_bib28","series-title":"Guidance on the Application of the CLP Criteria","year":"2015"},{"key":"10.1016\/j.yrtph.2019.01.022_bib29","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1097\/01.qai.0000159671.25950.74","article-title":"In vitro and in vivo: the story of nonoxynol-9","volume":"39","author":"Hillier","year":"2005","journal-title":"JAIDS J Acquir Immune Defic Syndr"},{"key":"10.1016\/j.yrtph.2019.01.022_bib30","doi-asserted-by":"crossref","unstructured":"Hubert P, Nguyen-Huu J-J, Boulanger B, Chapuzet E, Cohen N, Compagnon P-A, et al..: Harmonization of strategies for the validation of quantitative analytical procedures. A SFSTP proposal--part III. J. Pharmaceut. Biomed. Anal. 45:82\u201396.","DOI":"10.1016\/j.jpba.2007.06.032"},{"key":"10.1016\/j.yrtph.2019.01.022_bib31","unstructured":"in Vitro Assessment of Personal Care Products for Vaginal Irritation Using 3D Tissue Constructs 2006;6:1996."},{"key":"10.1016\/j.yrtph.2019.01.022_bib32","article-title":"CON4EI: EpiOcularTM Eye Irritation Test (EpiOcularTMEIT) for hazard identification and labelling of eye irritating chemicals","volume":"1\u201313","author":"Kandarova","year":"2017","journal-title":"Toxicol. Vitro"},{"key":"10.1016\/j.yrtph.2019.01.022_bib33","series-title":"Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices","first-page":"1","volume":"4","year":"2009"},{"key":"10.1016\/j.yrtph.2019.01.022_bib34","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1111\/j.1600-0536.2008.01359.x","article-title":"Contact allergy to benzocaine in a condom","volume":"59","author":"Muratore","year":"2008","journal-title":"Contact Dermatitis"},{"key":"10.1016\/j.yrtph.2019.01.022_bib35","doi-asserted-by":"crossref","first-page":"996","DOI":"10.1007\/s13361-012-0353-7","article-title":"Detection of the spermicide nonoxynol-9 via GC-MS","volume":"23","author":"Musah","year":"2012","journal-title":"J. Am. Soc. Mass Spectrom."},{"key":"10.1016\/j.yrtph.2019.01.022_bib37","unstructured":"SCCS Opinion on the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2- methylisothiazolin-3(2H)-one. Sccs\/1238\/09 2013;3:1\u201332."},{"key":"10.1016\/j.yrtph.2019.01.022_bib38","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1097\/DER.0b013e318284da33","article-title":"Allergic contact dermatitis of the vulva","volume":"24","author":"O'Gorman","year":"2013","journal-title":"Dermatitis"},{"key":"10.1016\/j.yrtph.2019.01.022_bib39","doi-asserted-by":"crossref","first-page":"1080","DOI":"10.1016\/S0002-9378(99)70598-3","article-title":"Effects of multiple applications of benzalkonium chloride and nonoxynol 9 on the vaginal epithelium in the pigtailed macaque (Macaca nemestrina)","volume":"180","author":"Patton","year":"1999","journal-title":"Am. J. Obstet. Gynecol."},{"key":"10.1016\/j.yrtph.2019.01.022_bib40","doi-asserted-by":"crossref","first-page":"293","DOI":"10.1111\/j.1600-0536.1996.tb02203.x","article-title":"Sensitization to benzocaine on a condom","volume":"34","author":"Placucci","year":"1996","journal-title":"Contact Dermatitis"},{"key":"10.1016\/j.yrtph.2019.01.022_bib41","doi-asserted-by":"crossref","first-page":"337","DOI":"10.1016\/j.contraception.2015.11.008","article-title":"Engineering and characterization of simplified vaginal and seminal fluid simulants","volume":"93","author":"Rastogi","year":"2016","journal-title":"Contraception"},{"key":"10.1016\/j.yrtph.2019.01.022_bib42","unstructured":"EU regulation 1223\/2009 on cosmetic products, Official Journal of the European union 342\/59, p. 1-151."},{"key":"10.1016\/j.yrtph.2019.01.022_bib43","unstructured":"EU regulation 745\/2017 on medical devices, Official Journal of the European union 117\/145, p. 1-175."},{"key":"10.1016\/j.yrtph.2019.01.022_bib44","unstructured":"SCCNFP\/0522\/01, Concerning Salicylic Acid, SCCNFP\/0522\/01, Adopted during the 20th Plenary Meeting of 4 June 2002 Nov."},{"key":"10.1016\/j.yrtph.2019.01.022_bib45","series-title":"SCCS\/1564\/15, the SCCS's Notes of Guidance for the Testing of Cosmetic Substances and Their Safety Evaluation 9, Adopted during the 11th Plenary Meeting","author":"SCCS 2016","year":"2015"},{"key":"10.1016\/j.yrtph.2019.01.022_bib46","series-title":"P94 ) Submission II ( Sensitisation Only )","author":"Scientific Committee on Consumer Safety Opinion on Methylisothiazolinone ( MI )","year":"2013"},{"key":"10.1016\/j.yrtph.2019.01.022_bib47","series-title":"P94 ) Submission III ( Sensitisation Only )","author":"Scientific Committee on Consumer Safety Opinion on Methylisothiazolinone ( MI )","year":"2015"},{"key":"10.1016\/j.yrtph.2019.01.022_bib48","doi-asserted-by":"crossref","first-page":"137","DOI":"10.1016\/0887-2333(90)90035-R","article-title":"The in vitro percutaneous absorption of diquat: a species comparison","volume":"4","author":"Scott","year":"1990","journal-title":"Toxicol. Vitro"},{"key":"10.1016\/j.yrtph.2019.01.022_bib49","doi-asserted-by":"crossref","first-page":"407","DOI":"10.1016\/j.yrtph.2016.09.028","article-title":"Tiered application of the neutral red release and EpiOcularTM assays for evaluating the eye irritation potential of agrochemical formulations","volume":"81","author":"Settivari","year":"2016","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"10.1016\/j.yrtph.2019.01.022_bib50","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1016\/S1046-199X(99)90000-3","article-title":"A l0-year retrospective study on benzocaine allergy in the United Kingdom","volume":"10","author":"Sidhu","year":"1999","journal-title":"Am J contact Dermat"},{"key":"10.1016\/j.yrtph.2019.01.022_bib51","doi-asserted-by":"crossref","first-page":"170","DOI":"10.1016\/j.ijwd.2015.08.005","article-title":"Infection or allergy? The multifaceted nature of vulvar dermatoses","volume":"1","author":"Vij","year":"2015","journal-title":"Int J Women\u2019s Dermatology"},{"key":"10.1016\/j.yrtph.2019.01.022_bib52","first-page":"392","volume":"2","author":"Weber","year":"2005","journal-title":"The Development of Vaginal Microbicides for the Prevention of HIV Transmission"},{"key":"10.1016\/j.yrtph.2019.01.022_bib36","first-page":"p1","article-title":"WHO\/UNFPA, male latex Condom\u202f: specification, prequalification and guidelines for procurement","year":"2013","journal-title":"Revised"},{"key":"10.1016\/j.yrtph.2019.01.022_bib53","series-title":"CONRAD Technical Consultation on Nonoxynol-9","author":"WHO","year":"2001"}],"container-title":["Regulatory Toxicology and Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0273230019300224?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0273230019300224?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2022,9,10]],"date-time":"2022-09-10T11:30:22Z","timestamp":1662809422000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0273230019300224"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,4]]},"references-count":53,"alternative-id":["S0273230019300224"],"URL":"https:\/\/doi.org\/10.1016\/j.yrtph.2019.01.022","relation":{},"ISSN":["0273-2300"],"issn-type":[{"value":"0273-2300","type":"print"}],"subject":[],"published":{"date-parts":[[2019,4]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Consumer protection provided by the European medical device and cosmetic legislation for condoms and lubricants","name":"articletitle","label":"Article Title"},{"value":"Regulatory Toxicology and Pharmacology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.yrtph.2019.01.022","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2019 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}