Amended Safety Assessment of Methylchloroisothiazolinone and Methylisothiazolinone as Used in Cosmetics

1. Elder, RL . Final report on the safety assessment of methylisothiazolinone and methylchloroisothiazolinone. JACT. 1992;11(1):75–128.
Google Scholar2. Nikitakis, J, Kowcz, A. wINCI: international cosmetic ingredient dictionary and handbook. Last Updated 2019. Accessed February 7, 2019. http://webdictionary.personalcarecouncil.org/jsp/home.jsp
Google Scholar3. Burnett, CL, Boyer, IJ, Bergfeld, WF, et al. Amended safety assessment of methylisothiazolinone as used in cosmetics. Int J Toxicol. 2019;38(suppl 1):70S–84S. https://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/PR646.pdf
Google Scholar4. U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition (CFSAN) . Voluntary Cosmetic Registration Program - Frequency of Use of Cosmetic Ingredients. Obtained under the Freedom of Information Act from CFSAN; requested as Frequency of Use Data. Published January 3, 2019. Accessed February 13, 2019.
Google Scholar5. Personal Care Products Council . Concentration of use by FDA product category - MCI/MI (ratio approximately 3:1). Unpublished data submitted by the Personal Care Products Council on May 2, 2019.
Google Scholar6. European Union . Regulation (EC) No. 1223/2009 of the European parliament and of the council of 30 November 2009 on cosmetic products. Published 2009. Accessed November 9, 2017. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF
Google Scholar7. Scientific Committee on Consumer Safety (SCCS) . Opinion on the Mixture of 5-Chloro-2-Methylisothiazolin-3(2H)-one and 2-Methylisothiazolin-3(2H)-One. European Commission; Published 2009. Accessed February 7, 2019. https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_009.pdf. Report No. SCCS/1238/09
Google Scholar8. European Union . Commission regulation (EU) 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. >Published 2016. Accessed September 23, 2019. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R1198&from=EN
Google Scholar9. Thomsen, AV, Schwensen, JF, Bossi, R, et al. Isothiazolinones are still widely used in paints purchased in five European countries: a follow-up study. Contact Dermatitis. 2017;78(4):246–253.
Google Scholar | Crossref | Medline10. Schettgen, T, Kraus, T. Urinary excretion kinetics of the metabolite N-methylmalonamic acid (NMMA) after oral doseage of chloromethylisothiazolinone and methylisothiazolinone in human volunteers. Arch Toxicol. 2017;91(12):3835–3841.
Google Scholar | Crossref | Medline11. Pelletier, G, Valli, VE, Rigden, M, Poon, R. Effects of a 28-day oral exposure to a 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one biocide formulation in sprague-dawley rats. Drug Chem Toxicol. 2014;37(2):149–155.
Google Scholar | Crossref | Medline12. Anonymous . 13-week inhalation toxicity study in rats (1984): study summary. Unpublished data submitted by the Personal Care Products Council on November 22, 2019.
Google Scholar13. Connor, TH, Tee, PG, Afshar, M, Connor, KM. Mutagenicity of cosmetic products containing Kathon. Envrion Mol Mutagen. 1996;28(2):127–132.
Google Scholar | Crossref | Medline14. Cantor Research Laboratories,Inc . 50 human subject repeat insult patch test skin irritation/sensitization evaluation (open patch; hand wash containing 12 ppm MCI/MI). Unpublished data submitted by the Personal Care Products Council on May 1, 2019.
Google Scholar15. Isaksson, M, Gruvberger, B, Goncalo, M, Goossens, A, Le Coz, CJ, Bruze, M. Repeated open application test with methylisothiazolinone in individuals sensitive to methylchloroisothiazolinone/methylisothiazolinone. Contact Dermatitis. 2014;70(4):244–246.
Google Scholar | Crossref | Medline16. Aerts, O, Goossens, A, Marguery, MC, et al. Photoaggravated allergic contact dermatitis and transiet photosensitivity caused by methylisothiazolinone. Contact Dermatitis. 2017;78(4):241–245.
Google Scholar | Crossref | Medline17. Isaksson, M, Hauksson, I, Hindsen, M, Pontén, A, Svedman, C, Bruze, M. Methylisothiazolinone contact allergy is rising to alarming heights also in southern Sweden. Acta Derm Venereol. 2015;95(1):31–34.
Google Scholar | Crossref | Medline18. Stingeni, L, Bianchi, L, Foti, C, et al. An Italian multicentre study on methylchloroisothiazolinone/methylisothiazolinone contact sensitivity: understanding the structure-activity relationship. Contact Dermatitis. 2018;78(4):297–299.
Google Scholar | Crossref | Medline19. Czarnobilska, E, Obtulowicz, K, Dyga, W, Wsolek-Wnek, K, Spiewak, R. Contact hypersensitivity and allergic contact dermatitis among school children and teenagers with eczema. Contact Dermatitis. 2009;60(5):264–269.
Google Scholar | Crossref | Medline20. Urwin, R, Warburton, K, Carder, M, Turner, S, Agius, R, Wilkinson, SM. Methylchloroisothiazolinone and methylisothiazolinone contact allergy: an occupational perspective. Contact Dermatitis. 2015;72(6):381–386.
Google Scholar | Crossref | Medline21. Boonchai, W, Maneeprasopchoke, P, Chaweekulrat, P, Kasemsarn, P. Associated factors of widespread pattern of dermatitis among patch test population: 12-Year retrospective study. Australas J Dermatol. 2018;60(1):e40–45.
Google Scholar | Crossref | Medline22. Zirwas, MJ, Hamann, D, Warshaw, EM, et al. Epidemic of isothiazolinone allergy in North America: prevalence data from the North American contact dermatits group, 2013-2014. Dermatitis. 2017;28(3):204–209.
Google Scholar | Crossref | Medline23. DeKoven, JG, Warshaw, EM, Belsito, DV, et al. North American contact dermatitis group patch test results 2013-2014. Dermatitis. 2017;28(1):33–46.
Google Scholar | Crossref | Medline | ISI24. Agullo-Perez, A-D, Hervella-Garces, M, Oscoz-Jaime, S, Azcona-Rodríguez, M, Larrea-García, M, Yanguas-Bayona, JI. Perianal dermatitis. Dermatitis. 2017;28(4):270–275.
Google Scholar | Crossref | Medline25. Ali, FR, Shepherd, EL, Yell, LC, Buckley, DA, Williams, JD. Escalating methylisothiazolinone/methylchloroisothiazolinone allergy probably attributable to methylisothiazolinone in leave-on body cosmetics. Contact Dermatitis. 2014;70(5):316–317.
Google Scholar | Crossref | Medline26. Urwin, R, Craig, S, Latheef, F, Wilkinson, M. Methylisothiazolinone: the epidemic is declining - but not gone. Contact Dermatitis. 2017;76(5):301–302.
Google Scholar | Crossref | Medline27. Amsler, E, Aerts, O, Raison-Peyron, N, et al. Airborne allergic contact dermatitis caused by isothiazolinones in water-based paints: a retrospective study of 44 cases. Contact Dermatitis. 2017;77(3):163–170.
Google Scholar | Crossref | Medline28. Dararattanaroj, W, Pootongkam, S, Rojanawatsirivej, N, Wongpiyabovorn, J. Patterns and risk factors of causative contact allergens in Thai adult patients with contact dermatitis. Asian Pac J Allergy Immunol. 2017;35(1):27–32.
Google Scholar | Medline29. Salman, A . Methylchloroisothiazolinone and methylisothiazolinone contact allergy: a retrospective cohort study from a tertiary dermatology clinic in Turkey. Contact Dermatitis. 2019;80(3):193–194.
Google Scholar | Crossref | Medline30. Craig, S, Urwin, R, Latheef, F, Wilkinson, M. Patch test clinic experience of potential cross-reactivity of isothiazolinones. Contact Dermatitis. 2017;76(5):299–300.
Google Scholar | Crossref | Medline31. Yu, SH, Sood, A, Taylor, JS. Patch testing for methylisothiazolinone and methylchloroisothiazolinone-methylisothiazolinone contact allergy. JAMA Dermatol. 2016;152(1):67–72.
Google Scholar | Crossref | Medline | ISI32. Engfeldt, M, Ale, I, Andersen, KE, et al. Multicenter patch testing with methylchloroisothiazolinone/methylisothiazolinone in 100 and 200 ppm withint the international contact dermatitis research group. Dermatitis. 2017;28(3):215–218.
Google Scholar | Crossref | Medline33. Veverka, KK, Hall, MR, Yiannias, JA, et al. Trends in patch testing with the mayo clinic standard series, 2011-2015. Dermatitis. 2018;29(6):310–315.
Google Scholar | Crossref | Medline34. Vauhkala, A-R, Pesonen, M, Suomela, S, Kuuliala, O, Suuronen, K, Aalto-Korte, K. Occupational contact allergy to methylchloroisothiazolinone/methylisothiazolinone and methylisothiazolinone. Contact Dermatitis. 2015;73(3):150–156.
Google Scholar | Crossref | Medline35. Leiva-Salinas, M, Frances, L, Main-Cabanas, I, Bouret, AM, Silvestre, JF. Methylchloroisothiazolinone/methylisothaizolinone and methylisothiazolinone allergies can be detected by 200 ppm of methylchloroisiothiazolinone/methylisothiazolinone patch test concentration. Dermatitis. 2014;25(3):130–134.
Google Scholar | Crossref | Medline36. Warshaw, EM, Aschenbeck, KA, Zug, KA, et al. Wet wipe allergens: retrospective analysis from the North American contact dermatitis group 2011-2014. Dermatitis. 2017;28(1):64–69.
Google Scholar | Crossref | Medline37. Ponten, A, Bruze, M, Engfeldt, M, Hauksson, I, Isaksson, M. Concomitant contact allergies to formaldehyde, methylchloroisothiazolinone/methylisothiazolinone, methylisothiazolinone, and fragrance mixes I and II. Contact Dermatitis. 2016;75(5):285–289.
Google Scholar | Crossref | Medline38. Gallo, R, Signori, A, Gervasio, S, Riva, S, Parodi, A. Methylisothiazolinone contact allergy - are rinse-off cosmetics and household products relevant sources of exposure? Contact Dermatitis. 2016;75(5):319–321.
Google Scholar | Crossref | Medline39. Puangpet, P, Chawarug, A, McFadden, JP. Methylchloroisothiazolinone/methylisothiazolinone and methylisothiazolinone allergy. Dermatitis. 2015;26(2):99–102.
Google Scholar | Crossref | Medline40. Murad, A, Marren, P. Prevalence of methylchloroisothiazolinone and methylisothiazolinone contact allergy in facial dermatitis: a single centre Irish study. J Eur Acad Dermatol Venereol. 2016;30(1):60–62.
Google Scholar | Crossref | Medline41. Janach, M, Kuhne, A, Seifert, B, French, LE, Ballmer-Weber, B, Hofbauer, GF. Changing delayed-type sensitizations to the baseline series allergens over a decade at the Zurich University hospital. Contact Dermatitis. 2010;63(1):42–48.
Google Scholar | Crossref | Medline42. Higgins, E, Kirby, B, Rogers, S, Collins, P. Methylchloroisothiazolinone and methylisothiazolinone allergic contact dermamtitis and the effect of patch test concentration. Dermatitis. 2013;24(2):73–76.
Google Scholar | Crossref | Medline43. Warshaw, EM, Maibach, HI, Taylor, JS, et al. North American contact dermatitis group patch test results: 2011-2012. Dermatitis. 2015;26(1):49–59.
Google Scholar | Crossref | Medline44. Mose, AP, Lundov, MD, Zachariae, C, et al. Occupational contact dermatitis in painters - an analysis of patch test data from the danish contact dermatitis group. Contact Dermatitis. 2012;67(5):293–297.
Google Scholar | Crossref | Medline45. Rios Scherrer, MA, Rocha, VB. Increasing trend of sensitization to methylchloroisothiazolinone/methylisothiazolinone (MCI/MI). An Bras Dermatol. 2014;89(3):527–528.
Google Scholar | Crossref | Medline46. Ponyai, G, Nemeth, I, Temesvari, E. Methylchloroisothiazolinone/methylisothiazolinone and methylisothiazolinone sensitivity in hungary. Dermatol Res Pract. 2016;2016(4579071):1–5.
Google Scholar | Crossref47. Schwensen, JF, Menne, T, Andersen, KE, Sommerlund, M, Johansen, JD. Occupations at risk of developing contact allergy to isothiazolinones in danish contact dermatitis patients: results from a danish multicentre study (2009-2012). Contact Dermatitis. 2014;71(5):295–302.
Google Scholar | Crossref | Medline48. Gimenez-Arnau, AM, Deza, G, Bauer, A, et al. Contact allergy to preservatives: ESSCA resutls with the baseline series, 2009-2012. J Eur Acad Dermatol Venereol. 2017;31(4):664–671.
Google Scholar | Crossref | Medline49. Akan, A, Toyran, M, Vezir, E, et al. The patterns and clinical relevance of contact allergen sensitization in a pediatric population with atopic dermatitis. Turk J Med Sci. 2015;45(6):1207–1213.
Google Scholar | Crossref | Medline50. Alinaghi, F, Bennike, NH, Egeberg, A, Thyssen, JP, Johansen, JD. Prevalence of contact allergy in the general population: a systemic review and meta-analysis. Contact Dermatitis. 2019;80(2):77–85.
Google Scholar | Crossref | Medline51. Wolf, R, Orion, E, Matz, H. Co-existing sensitivity to metronidazole and isothiazolinone. Clin Exp Dermatol. 2003;28(5):506–507

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