{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T05:06:39Z","timestamp":1790658399668,"version":"4.1.0"},"reference-count":107,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2018,6,1]],"date-time":"2018-06-01T00:00:00Z","timestamp":1527811200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"funder":[{"DOI":"10.13039\/100000066","name":"NIEHS","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000066","id-type":"DOI","asserted-by":"crossref"}]},{"name":"NIH","award":["HHSN273201500010C"],"award-info":[{"award-number":["HHSN273201500010C"]}]}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Regulatory Toxicology and Pharmacology"],"published-print":{"date-parts":[[2018,6]]},"DOI":"10.1016\/j.yrtph.2018.03.003","type":"journal-article","created":{"date-parts":[[2018,3,5]],"date-time":"2018-03-05T23:07:33Z","timestamp":1520291253000},"page":"52-65","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":88,"special_numbering":"C","title":["International regulatory requirements for skin sensitization testing"],"prefix":"10.1016","volume":"95","author":[{"given":"Amber B.","family":"Daniel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4112-7484","authenticated-orcid":false,"given":"Judy","family":"Strickland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Allen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Casati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Val\u00e9rie","family":"Zuang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo\u00e3o","family":"Barroso","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurice","family":"Whelan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.J.","family":"R\u00e9gimbald-Krnel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajime","family":"Kojima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akiyoshi","family":"Nishikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hye-Kyung","family":"Park","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jong Kwon","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae Sung","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabella","family":"Delgado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3023-7247","authenticated-orcid":false,"given":"Ludmila","family":"Rios","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gangli","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Kleinstreuer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib1","first-page":"13","article-title":"Resolution RDC N\u00b0 10\/1999 on disposable hygienic products of 21 October 1999","volume":"204-E","author":"ANVISA","year":"1999","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib2","first-page":"29","article-title":"Resolution RDC N\u00b0 14\/2007 on new active ingredient of an antimicrobial pesticide for general use of 28 February 2007","volume":"43","author":"ANVISA","year":"2007","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib3","first-page":"42","article-title":"Resolution RDC N\u00b0 34\/2010 on active ingredient insecticide in a microbial pesticide for professional use of 16 August 2010","volume":"158","author":"ANVISA","year":"2010","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib4","first-page":"44","article-title":"Resolution RDC N\u00b0 35\/2010 on new active ingredient antimicrobial pesticide for general use of 16 August 2010","volume":"158","author":"ANVISA","year":"2010","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"key":"10.1016\/j.yrtph.2018.03.003_bib5","series-title":"Bras\u00edlia: Guidance for Safety Evaluation of Cosmetic Products","author":"ANVISA","year":"2012"},{"key":"10.1016\/j.yrtph.2018.03.003_bib6","series-title":"Bras\u00edlia: Guidance for Development of Non-clinical Studies to Assess Safety Pharmacology and Toxicology of Drugs","author":"ANVISA","year":"2013"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib7","first-page":"59","article-title":"Resolution RDC N\u00b0 19\/2013 on cosmetic insect repellents products of 10 April 2013","volume":"69","author":"ANVISA","year":"2013","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib8","first-page":"47","article-title":"Resolution RDC N\u00b0 15\/2015 on cosmetic products intended for children's use of 24 April 2015","volume":"78","author":"ANVISA","year":"2015","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib9","first-page":"44","article-title":"Resolution RDC N\u00b0 35\/2015 on acceptance of alternative methods of 7 August 2015","volume":"151","author":"ANVISA","year":"2015","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib10","first-page":"43","article-title":"Public Consultation Act N\u00b0 260\/2016 on toxicological evaluation of pesticide products to plant protection of 10 October 2016","volume":"196","author":"ANVISA","year":"2016","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib11","first-page":"44","article-title":"Public Consultation Act N\u00b0 262\/2016 on toxicological classification of pesticide products to plant protection of 10 October 2016","volume":"196","author":"ANVISA","year":"2016","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"key":"10.1016\/j.yrtph.2018.03.003_bib12","article-title":"Federal Law N\u00b0 6360\/1976 on household pesticides","author":"Brazil","year":"1976","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"key":"10.1016\/j.yrtph.2018.03.003_bib13","article-title":"Federal Law N\u00b0 7802\/1989 on pesticide products to plant protection","author":"Brazil","year":"1989","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"key":"10.1016\/j.yrtph.2018.03.003_bib14","first-page":"295","article-title":"Ordinance N\u00b0 1480\/1990 on disposable hygienic products of 31 December 1990","volume":"1","author":"Brazilian Ministry of Health","year":"1990","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"2","key":"10.1016\/j.yrtph.2018.03.003_bib17","doi-asserted-by":"crossref","first-page":"611","DOI":"10.1007\/s00204-017-2097-4","article-title":"Standardisation of defined approaches for skin sensitisation testing to support regulatory use and international adoption: position of the International Cooperation on Alternative Test Methods","volume":"92","author":"Casati","year":"2018","journal-title":"Arch. Toxicol."},{"key":"10.1016\/j.yrtph.2018.03.003_bib18","unstructured":"CFDA, Guide of cosmetics products import into Chinese Market, Undated, Available at: http:\/\/www.sfdachina.com\/info\/110-1.htm, Accessed 8 December 2016]."},{"key":"10.1016\/j.yrtph.2018.03.003_bib19","series-title":"The Technical Safety Standards for Cosmetics (2015) Will Come Into Effect by Dec 2016","author":"CIRS","year":"2016"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib20","first-page":"9","article-title":"Normative resolution N\u00b0 18\/2014 on alternative methods of 24 September 2014","volume":"185","author":"CONCEA","year":"2014","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib21","first-page":"4","article-title":"Normative resolution N\u00b0 31\/2016 on alternative methods of 19 August 2016","volume":"160","author":"CONCEA","year":"2016","journal-title":"Di\u00e1rio Oficial da Uni\u00e3o"},{"key":"10.1016\/j.yrtph.2018.03.003_bib23","series-title":"Recommended Procedures Regarding the CPSC's Policy on Animal Testing","author":"CPSC","year":"2012"},{"key":"10.1016\/j.yrtph.2018.03.003_bib24","first-page":"169","article-title":"Council Directive 76\/768\/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products","volume":"L262","author":"EC","year":"1976","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib25","first-page":"67","article-title":"Directive 2001\/83\/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use","volume":"L311","author":"EC","year":"2001","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib26","first-page":"26","article-title":"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","volume":"L66","author":"EC","year":"2003","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib27","first-page":"1","volume":"396","author":"EC","year":"2006","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib28","first-page":"1","article-title":"Commission regulation (EC) No 440\/2008 of 30 May 2008 laying down test methods pursuant to regulation (EC) No 1907\/2006 of the European Parliament and of the Council on the registration, evaluation, authorisation and restriction of chemicals (REACH)","volume":"L142","author":"EC","year":"2008","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib29","first-page":"1","volume":"L353","author":"EC","year":"2008","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib30","first-page":"1","article-title":"Regulation (EC) No 1107\/2009 concerning the placing of plant protection products on the market","volume":"L309","author":"EC","year":"2009","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib31","first-page":"59","article-title":"Regulation (EC) No 1223\/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products","volume":"L342","author":"EC","year":"2009","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib32","first-page":"1","article-title":"Regulation (EU) No 528\/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products","volume":"L167","author":"EC","year":"2012","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib33","first-page":"1","volume":"L93","author":"EC","year":"2013","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib34","first-page":"85","volume":"L93","author":"EC","year":"2013","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib35","first-page":"14","volume":"L255","author":"EC","year":"2016","journal-title":"Offic. J. Eur. Union"},{"key":"10.1016\/j.yrtph.2018.03.003_bib36","series-title":"Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.7a: Endpoint Specific Guidance (Version 6.0)","author":"ECHA","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib37","series-title":"Guideline on Non-clinical Local Tolerance Testing of Medicinal Products","author":"EMA","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib38","series-title":"Health Effects Test Guidelines: OPPTS 870.2600-Skin Sensitization. EPA 712-C-03\u2013197","author":"EPA","year":"2003"},{"key":"10.1016\/j.yrtph.2018.03.003_bib39","series-title":"Expansion of the Traditional Local Lymph Node Assay for the Assessment of Dermal Sensitization Potential of End Use Pesticide Products; and Adoption of a \"Reduced\" Protocol for the Traditional LLNA (Limit Dose)","author":"EPA","year":"2011"},{"key":"10.1016\/j.yrtph.2018.03.003_bib40","series-title":"Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products (Acute Oral, Acute Dermal, Acute Inhalation, Primary Eye, Primary Dermal, and Dermal Sensitization) (March 1, 2012)","author":"EPA","year":"2012"},{"key":"10.1016\/j.yrtph.2018.03.003_bib41","series-title":"Toxicology Data Requirement Table, 40 CFR 158.500","author":"EPA","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib42","series-title":"Toxicology, 40 CFR 158.2230","author":"EPA","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib43","series-title":"The Frank R. Lautenberg Chemical Safety for the 21st Century Act","author":"EPA","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib44","series-title":"Use of the Local Lymph Node Assay and Reduced Dose Protocol for LLNA in Assessing Pesticide Products","author":"EPA","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib45","series-title":"ESAC Opinion on the BASF-coordinated Performance Standards-based Validation of the LuSens Test Method for Skin Sensitisation Testing. ESAC Opinion No. 2016-04 of 24 June 2016","author":"EURL ECVAM Scientific Advisory Committee","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib46","series-title":"ESAC Opinion on the L'Or\u00e9al-coordinated Study on the Transferability and Reliability of the U-SENS\u2122 Test Method for Skin Sensitisation Testing. ESAC Opinion No. 2016-03 of 24 June 2016","author":"EURL ECVAM Scientific Advisory Committee","year":"2016"},{"issue":"12","key":"10.1016\/j.yrtph.2018.03.003_bib47","doi-asserted-by":"crossref","first-page":"2861","DOI":"10.1007\/s00204-016-1842-4","article-title":"State of the art in non-animal approaches for skin sensitization testing: from individual test methods towards testing strategies","volume":"90","author":"Ezendam","year":"2016","journal-title":"Arch. Toxicol."},{"issue":"42","key":"10.1016\/j.yrtph.2018.03.003_bib48","first-page":"8912","article-title":"Cosmetic Products: warning statements\/package labels","volume":"40","author":"FDA","year":"1975","journal-title":"Fed Reg"},{"key":"10.1016\/j.yrtph.2018.03.003_bib49","series-title":"Guidance for Industry and FDA Staff: Medical Glove Guidance Manual","author":"FDA","year":"2008"},{"key":"10.1016\/j.yrtph.2018.03.003_bib50","series-title":"About the Center for Drug Evaluation and Research","author":"FDA","year":"2014"},{"key":"10.1016\/j.yrtph.2018.03.003_bib51","series-title":"Cosmetic Product Warning Statements, 21 CFR 740","author":"FDA","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib52","series-title":"Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993\u20131, \u201cBiological Evaluation of Medical Devices \u2013 Part 1: Evaluation and Testing within a Risk Management Process\u201d","author":"FDA","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib53","series-title":"About the Center for Devices and Radiologic Health","author":"FDA","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib54","series-title":"Federal Food, Drug, and Cosmetic Act of 1938","author":"21 U.S.C. \u00a7301 et seq.","year":"1938"},{"key":"10.1016\/j.yrtph.2018.03.003_bib55","series-title":"Federal Insecticide, Fungicide, and Rodenticide Act of 1947","author":"7 U.S.C. \u00a7136 et seq.","year":"1996"},{"key":"10.1016\/j.yrtph.2018.03.003_bib58","series-title":"Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers, Pursuant to Section 69 of the Canadian Environmental Protection Act, 1999","author":"Government of Canada","year":"2006"},{"key":"10.1016\/j.yrtph.2018.03.003_bib59","series-title":"Notice of Release of the Final Guidance Document: Human-use Antiseptic Drugs","author":"Health Canada","year":"2009"},{"key":"10.1016\/j.yrtph.2018.03.003_bib60","series-title":"Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides","author":"Health Canada","year":"2013"},{"key":"10.1016\/j.yrtph.2018.03.003_bib61","series-title":"Guidance Document: Disinfectant Drugs","author":"Health Canada","year":"2014"},{"key":"10.1016\/j.yrtph.2018.03.003_bib63","series-title":"Guidance for Developing Datasets for Conventional Pest Control Product Applications: Data Codes for Parts 1, 2, 3, 4, 5, 6, 7 & 10","author":"Health Canada","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib64","series-title":"Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, ICH Topic M3(R2)","author":"Health Canada","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib65","series-title":"Natural and Non-prescription Health Products Directorate","author":"Health Canada","year":"2016"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib66","doi-asserted-by":"crossref","first-page":"1","DOI":"10.5650\/jos.ess13501","article-title":"Safety assurance of cosmetic in Japan: current situation and future prospects","volume":"63","author":"Inomata","year":"2014","journal-title":"J. Oleo Sci."},{"key":"10.1016\/j.yrtph.2018.03.003_bib67","series-title":"ISO 10993\u201310: Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization","author":"ISO","year":"2010"},{"key":"10.1016\/j.yrtph.2018.03.003_bib68","series-title":"EURL ECVAM Recommendation on the Direct Peptide Reactivity Assay (DPRA) for Skin Sensitisation Testing","author":"Joint Research Centre of the European Union","year":"2013"},{"key":"10.1016\/j.yrtph.2018.03.003_bib69","series-title":"EURL ECVAM Recommendation on the KeratinoSens\u2122 Assay for Skin Sensitisation Testing","author":"Joint Research Centre of the European Union","year":"2014"},{"key":"10.1016\/j.yrtph.2018.03.003_bib70","series-title":"EURL ECVAM Recommendation on the Human Cell Line Activation Test (H-CLAT) for Skin Sensitisation Testing","author":"Joint Research Centre of the European Union","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib71","doi-asserted-by":"crossref","DOI":"10.1080\/10408444.2018.1429386","article-title":"Non-animal methods to predict skin sensitization (II): an assessment of defined approaches","author":"Kleinstreuer","year":"2018","journal-title":"Crit. Rev. Toxicol."},{"key":"10.1016\/j.yrtph.2018.03.003_bib72","series-title":"The Guidelines Related to the Study Reports for the Registration Application of Pesticide. Appendix to the Director General Notification","author":"MAFF","year":"2000"},{"key":"10.1016\/j.yrtph.2018.03.003_bib74","series-title":"MERCOSUR Common Market Group: Resolution N\u00b0 050\/2006 on New Active Ingredient of an Antimicrobial Pesticide for General Use, Bras\u00edlia","author":"MERCOSUR","year":"2006"},{"key":"10.1016\/j.yrtph.2018.03.003_bib75","series-title":"MERCOSUR Common Market Group: Resolution N\u00b0 18\/2010 on Active Ingredient Insecticide in a Microbial Pesticide for Professional Use, Buenos Aires","author":"MERCOSUR","year":"2010"},{"key":"10.1016\/j.yrtph.2018.03.003_bib76","series-title":"MERCOSUR Common Market Group: Resolution N\u00b0 19\/2010 on New Active Ingredient Antimicrobial Pesticide for General Use, Buenos Aires","author":"MERCOSUR","year":"2010"},{"key":"10.1016\/j.yrtph.2018.03.003_bib15","series-title":"Canada Consumer Product Safety Act","author":"Minister of Justice Canada","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib16","series-title":"Canadian Environmental Protection Act, 1999","author":"Minister of Justice Canada","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib22","unstructured":"Minister of Justice Canada, Cosmetic Regulations, 2007, (C.R.C., C. 869)."},{"key":"10.1016\/j.yrtph.2018.03.003_bib56","series-title":"Food and Drugs Act","author":"Minister of Justice Canada","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib57","series-title":"Food and Drugs Regulations","author":"Minister of Justice Canada","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib73","series-title":"Medical Devices Regulations","author":"Minister of Justice Canada","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib77","series-title":"Hazardous Products Regulations","author":"Minister of Justice Canada","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib78","series-title":"Hazardous Products Act","author":"Minister of Justice Canada","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib79","series-title":"Pest Control Products Regulations","author":"Minister of Justice Canada","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib80","series-title":"Pesticide Control Act","author":"Ministry of Agriculture Food and Rural Affairs","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib81","series-title":"Occupational Safety and Health Act","author":"Ministry of Employment and Labor","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib82","series-title":"Pharmaceutical Affairs Act","author":"Ministry of Food and Drug Safety","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib83","series-title":"Regulations on the Examination of Functional Cosmetics","author":"Ministry of Food and Drug Safety","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib84","series-title":"Standard for Toxicity Study of Pharmaceuticals","author":"Ministry of Food and Drug Safety","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib85","series-title":"Cosmetics Act","author":"Ministry of Food and Drug Safety","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib86","series-title":"No 13\/1991. Detailed Rules for the Implementation of the Regulation on the Hygiene Supervision over Cosmetics","author":"Ministry of Health","year":"1991"},{"key":"10.1016\/j.yrtph.2018.03.003_bib87","series-title":"No 3\/1989. Regulations Concerning the Hygiene Supervision over Cosmetics","author":"Ministry of Health","year":"1989"},{"key":"10.1016\/j.yrtph.2018.03.003_bib88","series-title":"Act on the Registration and Evaluation of Chemicals","author":"MOE","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib89","series-title":"Janeway's Immunobiology","author":"Murphy","year":"2012"},{"key":"10.1016\/j.yrtph.2018.03.003_bib90","series-title":"Toxicological Test Methods of Pesticides for Registration, GB 15670\u20131995","author":"National Standard of the People's Republic of China","year":"1995"},{"key":"10.1016\/j.yrtph.2018.03.003_bib91","series-title":"Occupational Safety and Health Act of 1970","author":"29 U.S.C. \u00a7651 et seq.","year":"1970"},{"key":"10.1016\/j.yrtph.2018.03.003_bib92","series-title":"OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects","article-title":"Skin sensitisation","author":"OECD, Test No. 406","year":"1992"},{"key":"10.1016\/j.yrtph.2018.03.003_bib93","series-title":"OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects","article-title":"Skin sensitisation: local lymph node assay","author":"OECD, Test No. 429","year":"2010"},{"key":"10.1016\/j.yrtph.2018.03.003_bib94","series-title":"OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects","article-title":"Skin sensitization: local lymph node assay: DA","author":"OECD, Test No. 442A","year":"2010"},{"key":"10.1016\/j.yrtph.2018.03.003_bib95","series-title":"OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects","article-title":"Skin sensitization: local lymph node assay: BrdU-ELISA","author":"OECD, Test No. 442B","year":"2010"},{"key":"10.1016\/j.yrtph.2018.03.003_bib96","series-title":"OECD Series on Testing and Assessment No. 168. The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins. Part 1: Scientific Assessment. ENV\/JM\/MONO(2012)10\/(PART1)","author":"OECD","year":"2012"},{"key":"10.1016\/j.yrtph.2018.03.003_bib97","series-title":"OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects","article-title":"In chemico skin sensitization: direct peptide reactivity assay (DPRA)","author":"OECD, Test No. 442C","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib98","series-title":"OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects","article-title":"In vitro skin sensitisation: ARE-Nrf2 Luciferase test method","author":"OECD, Test No. 442D","year":"2015"},{"key":"10.1016\/j.yrtph.2018.03.003_bib99","series-title":"OECD Series on Testing and Assessment No. 237. Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests","author":"OECD","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib100","series-title":"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","author":"OECD","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib101","series-title":"OECD Series on Testing and Assessment No. 256. 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. Annex 1","author":"OECD","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib102","series-title":"OECD Guidelines for the Testing of Chemicals, Section 4: Health Effects","article-title":"In vitro skin sensitisation: in vitro skin sensitisation assays addressing the key event on activation of dendritic cells on the adverse outcome pathway for skin sensitisation","author":"OECD, Test No. 442E","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib103","series-title":"Work Plan for the Test Guidelines Program (TGP) as of August 2017","author":"OECD","year":"2017"},{"key":"10.1016\/j.yrtph.2018.03.003_bib104","series-title":"Guidance on Use of Combination of in Vitro Skin Sensitisation Assays in the Safety Assessment of Cosmetics and Quasi-drug","author":"PMDA","year":"2018"},{"issue":"1","key":"10.1016\/j.yrtph.2018.03.003_bib105","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1016\/j.yrtph.2007.11.004","article-title":"The Research Institute for Fragrance Materials' human repeated insult patch test protocol","volume":"52","author":"Politano","year":"2008","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"10.1016\/j.yrtph.2018.03.003_bib106","series-title":"Standard for the Registration of Pesticidies and Active Substances","author":"Rural Development Administration","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib107","series-title":"The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, 9th Revision","author":"SCCS","year":"2016"},{"key":"10.1016\/j.yrtph.2018.03.003_bib108","series-title":"Globally Harmonised System of Classification and Labelling of Chemicals (GHS)","doi-asserted-by":"crossref","DOI":"10.18356\/e9e7b6dc-en","author":"UN","year":"2017"}],"container-title":["Regulatory Toxicology and Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0273230018300667?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0273230018300667?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,8,23]],"date-time":"2018-08-23T12:24:38Z","timestamp":1535027078000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0273230018300667"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,6]]},"references-count":107,"alternative-id":["S0273230018300667"],"URL":"https:\/\/doi.org\/10.1016\/j.yrtph.2018.03.003","relation":{},"ISSN":["0273-2300"],"issn-type":[{"value":"0273-2300","type":"print"}],"subject":[],"published":{"date-parts":[[2018,6]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"International regulatory requirements for skin sensitization testing","name":"articletitle","label":"Article Title"},{"value":"Regulatory Toxicology and Pharmacology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.yrtph.2018.03.003","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2018 Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}