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A Study on the Safety of Alcohol-based Hand Sanitizers

알코올을 주성분으로 하는 손소독제의 안전성 연구

  • Sun-Ok Jung (Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Chun-Yeong Lee (Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Hoe-Jin Ryu (Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Hee-Jin Choi (Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Ji-Young Kim (Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Chae-Man Choi (Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • In-Sook Hwang (Seoul Metropolitan Government Research Institute of Public Health and Environment) ;
  • Yong-Seung Shin (Seoul Metropolitan Government Research Institute of Public Health and Environment)
  • 정선옥 (서울특별시보건환경연구원) ;
  • 이춘영 (서울특별시보건환경연구원) ;
  • 류회진 (서울특별시보건환경연구원) ;
  • 최희진 (서울특별시보건환경연구원) ;
  • 김지영 (서울특별시보건환경연구원) ;
  • 최채만 (서울특별시보건환경연구원) ;
  • 황인숙 (서울특별시보건환경연구원) ;
  • 신용승 (서울특별시보건환경연구원)
  • Received : 2022.12.26
  • Accepted : 2023.02.21
  • Published : 2023.03.31

Abstract

Objectives: In this study, the safety of alcohol-based hand sanitizers (ABHSs) for quasi-drugs and cosmetics was investigated by analyzing the ethanol content, which is an active ingredient with a sterilizing effect, and methanol, which is toxic. Methods: Forty-one ABHSs were purchased at large supermarkets and online stores. Ethanol quantification was performed by gas chromatography-flame ionization detector, and methanol quantification was performed by headspace-gas chromatography-mass spectrometry. Results: The ethanol content of ABHS in quasi-drugs was 49.6-67.8%, which was suitable for standard manufacturing procedures for external disinfectants, and the ethanol content of ABHS in cosmetics was 9.1-61.3%. The methanol content of ABHS in quasi-drugs ranged from not detected(N.D.)-131.8 ppm, which was suitable for the methanol detection standard of ethanol raw materials in the Korean Pharmacopoeia. The methanol content of ABHS in cosmetics was 23.4-859.7 ppm, which was suitable for the detection limit of methanol in cosmetics. Conclusions: The ethanol and methanol content of ABHS was judged to be safe. When selecting an ABHS to be used for sterilization, it seems necessary to check the content of ethanol, an active ingredient, and use it according to its intended purpose.

Keywords

References

  1. Centers for Disease Control and Prevention(CDC). Hand sanitizer use out and about [Accessed 2021 Aug 10]. Available from: URL:http://www.cdc.gov/handwashing/hand-sanitizer-use.html
  2. Choi JH, Lee SK, Gil YE, Ryu J, Jung-Choi K et al. Neurological complications resulting from non-oral occupational methanol poisoning. J Korean Med Sci 2017;32:371-376(http://doi.org/10.3346/jkms.2017.32.2.371)
  3. Chong MS, Lee JJ, Kim J. Comparison of bacterial removal effectiveness by different hand washing methods. J Korea Convergence Soc 2019;10(9):69-74(http://doi.org/10.15207/JKCS.2019.10.9.069)
  4. Food and Drug Administration(FDA). Tentative final monograph for health-care antiseptic drug products; proposed rule. Fed. Regist. 1994;59:31402-31452
  5. Food and Drug Administration(FDA). FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem [Accessed 2020 Jun 19]. Available from: URL:http://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-hand-sanitizer-products-manufactured-eskbiochem
  6. Food and Drug Administration(FDA). Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19) guidance for industry. 2021. p. 3-12
  7. Health Canada(HC). Two deaths linked to ingestion of hand sanitizer containing methanol [Accessed 2013 Oct 24]. Available from: URL:http://recalls-rappels.canada.ca/en/alert-recall/two-deaths-linked-ingestion-hand-sanitizer-containing-methanol
  8. Jairoun AA, Al-Hemyari SS, Shahwan M. The pandemic of COVID-19 and its implications for the purity and authenticity of alcohol-based hand sanitizers: The health risks associated with falsified sanitizers and recommendations for regulatory and public health bodies. Res Social Adm Pharm 2021;17: 2050-2051 (http://doi.org/10.1016/j.sapharm.2020.04.014)
  9. Kampf G. How effective are hand antiseptics for the postcontamination treatment of hands when used as recommended. Am J Infect Control 2008;36(5):356-360(http://doi.org/10.1016/j.ajic.2007.07.017)
  10. Kampf G. Efficacy of ethanol against viruses in hand disinfection. J Hospital Infection 2018;98:331-338 (http://dx.doi.org/10.1016/j.jhin.2017.08.025)
  11. Kampf G, Todt D, Pfaender S, Steinmann E. Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. J Hospital Infection 2020;104:246-251(http://doi.org/10.1016/j.jhin.2020.01.022)
  12. Kenters N, Eikelenboom-Boskamp A, Hines J, McGeer A, Huijskens EGW et al. Product dose considerations for real-world hand sanitiser efficacy. Am J Infect Control 2020;48:503-506(http://doi.org/10.1016/j.ajic.2019.12.001)
  13. Kratzel A, Todt D, V'kovski P, Steiner S, Gultom M et al. Inactivation of severe acute respiratory syndrome coronavirus 2 by WHO-recommended hand rub formulations and alcohols. Emerging Infect Dis 2020;26(7):1592-1595(http://doi.org/10.3201/eid2607.200915)
  14. Ministry of food and drug safety(MFDS). Standard manufacturing procedure for external disinfectants. MFDS Notice No. 2018a-14
  15. Ministry of Food and Drug Safety(MFDS). Manual of regulations on cosmetic safety standards. 2018b. p. 12-19
  16. Ministry of food and drug safety(MFDS). Korea Pharmacopeia. MFDS Notice No. 2019-102
  17. Ministry of food and drug safety(MFDS). Regulations on cosmetics safety standards. MFDS Notice No. 2020-12
  18. Ministry of food and drug safety(MFDS). Standard for quasi-drugs. MFDS Notice No. 2021-14
  19. Ministry of food and drug safety(MFDS). Food and drug production consumption trends based on food and drug statistics [Accessed 2022 Jan 27]. Available from: URL:https://www.mfds.go.kr/brd/m_99/view.do?seq=46102&srchFr=&srchTo=&srchWord=%EC%8B%9D%EC%9D%98%EC%95%BD+%ED%86%B5%EA%B3%84&srchTp=0&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&Data_stts_gubun=C9999&page=1
  20. Morbidity and Mortality Weekly Report(MMWR). Reported adverse health effects in children from ingestion of alcohol-based hand sanitizers-United States, 2011-2014.;2017;66(8):223-226. Available from: URL:http://www.cdc.gov/mmwr/volumes/66/wr/mm6608a5.htm
  21. Ohimain EI. Methanol contamination in traditionally fermented alcoholic beverages: the microbial dimension. SpringerPlus 2016;5:1607(http://doi.org/10.1186/s40064-016-3303-1)
  22. Onuki S, Koziel JA, Jenks WS, Cai L, Grewell D et al. Taking ethanol quality beyond fuel grade: A review. J Inst Brew 2016;122:588-598(http://doi.org/10.1002/jib.364)
  23. Public Health England(PHE). Methanol : Toxicological overview. 2015. p. 3-11
  24. Seoul City Hall(SCH). The Seoul Metropolitan Government has detected a manufacturer of false hand sanitizers with insufficient content [Accessed 2020 Apr 9]. Available from: URL: https://www.seoul.go.kr/news/news_report.do#view/312291
  25. Trampuz A, Widmer AF. Hand hygiene : A frequently missed lifesaving opportunity during patient care. Mayo Clinic Proceedings 2004;79:109-116(http://doi.org/10.4065/79.1.109)
  26. Tse TJ, Prudy SK, Shen J, Nelson FB, Mustafa R et al. Toxicology of alcohol-based hand rubs formulated with technical-grade ethanol. Toxicology Reports 2021;8:785-792(http://doi.org/10.1016/j.toxrep.2021.03.034)
  27. United States Pharmacopeia-National Formulary (USP-NF). USP monographs : Alcohol; 2020
  28. World Health Organization(WHO). WHO guidelines on hand hygiene in health care : first global patient safety challenge clean care is safer care. 2009. p. 49-53