CMIT/MIT 함유 가습기 살균제 제품의 제조 및 판매기업 형사판결 1심 재판 판결문에 대한 과학적 고찰 (I) - 제품 위험성과 노출평가 측면에서
A Scientific Critique of a Korean Court’s Acquittal for Involuntary Manslaughter Related to 5-chloro-2-methylisothiazol-3(2H)-one/ 2-methylisothiazol-3(2H)-one (CMIT/MIT), a Humidifier Disinfectant (HD) Part I: Material safety, exposure and delivery to target organ from an HD perspective
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Objectives: There was a judgment of acquittal for the manufacturer SK Chemical and the vendor Aekyung regarding humidifier disinfectant (HD) containing 5-chloro-2-methylisothiazol-3(2H)-one/2-methylisothiazol- 3(2H)-one (CMIT/MIT). The rationale used in this judgement is discussed here in the light of scientific consideration. Methods: The sentencing document for the judgements was obtained from the Korea Supreme Court Service. In particular, the judgements made by the court related to the risk of HD and external and internal exposure to CMIT/MIT are discussed based on scientific evidence. Results: Rendering a determination in a criminal trial of insufficient evidence of causation, the court dismissed the prosecution’s motion that humidifier disinfectant-associated lung injuries (HDLI) and asthma were associated with the utilization of these products. However, CMIT/MIT, a strong sensitizing and corrosive substance, has been reported to be associated with brain toxicity, allergic contact dermatitis, and asthma. Furthermore, the judgment did not consider total consumption amounts or the cumulative dose of CMIT/MIT in the humidifier. Lastly, there are several cases supporting the fact that exposure to water-soluble substances including CMIT/MIT can cause lower respiratory tract diseases. In addition to cases of asthma among the workers exposed to CMIT/ MIT, we identified lung injury victims who were exposed to HDs exclusively containing CMIT/MIT. Conclusions: We conclude that there is sufficient evidence supporting the assertion that HDs containing CMIT/ MIT cause lung injuries, including asthma, contrary to the court’s judgement.
Abstract
Objectives: There was a judgment of acquittal for the manufacturer SK Chemical and the vendor Aekyung regarding humidifier disinfectant (HD) containing 5-chloro-2-methylisothiazol-3(2H)-one/2-methylisothiazol- 3(2H)-one (CMIT/MIT). The rationale used in this judgement is discussed here in the light of scientific consideration. Methods: The sentencing document for the judgements was obtained from the Korea Supreme Court Service. In particular, the judgements made by the court related to the risk of HD and external and internal exposure to CMIT/MIT are discussed based on scientific evidence. Results: Rendering a determination in a criminal trial of insufficient evidence of causation, the court dismissed the prosecution’s motion that humidifier disinfectant-associated lung injuries (HDLI) and asthma were associated with the utilization of these products. However, CMIT/MIT, a strong sensitizing and corrosive substance, has been reported to be associated with brain toxicity, allergic contact dermatitis, and asthma. Furthermore, the judgment did not consider total consumption amounts or the cumulative dose of CMIT/MIT in the humidifier. Lastly, there are several cases supporting the fact that exposure to water-soluble substances including CMIT/MIT can cause lower respiratory tract diseases. In addition to cases of asthma among the workers exposed to CMIT/ MIT, we identified lung injury victims who were exposed to HDs exclusively containing CMIT/MIT. Conclusions: We conclude that there is sufficient evidence supporting the assertion that HDs containing CMIT/ MIT cause lung injuries, including asthma, contrary to the court’s judgement.
참고문헌 (44)
- "Amended Safety Assessment of Methylchloroisothiazolinone and Methylisothiazolinone as Used in Cosmetics" (2020)[URL]
- , 2006
- (2020)[URL]
- "Dirty Humidifiers May Cause Health Problems" (2012)[URL]
- He K, "Methylisothiazolinone, a neurotoxic biocide, disrupts the association of SRC family tyrosine kinases with focal adhesion kinase in developing cortical neurons", Journal of Pharmacology and Experimental Therapeutics, 317(3), pp.1320~1329 (2006)
- Jayjock M, "Formulation effect on the dermal bioavailability of isothiazolone biocide", Food and Chemical Toxicology, 34(3), pp.277~282 (1996)
- Do VQ, "A mixture of chloromethylisothiazolinone and methylisothiazolinone impairs rat vascular smooth muscle by depleting thiols and thereby elevating cytosolic Zn 2+ and generating reactive oxygen species", Archives of Toxicology, 95(2), pp.541~556 (2021)
- "European Chemical Agency (ECHA), Brief Profile:Reaction mass of 2-methyl-2H-isothiazol-3-one and 5-chloro-2-methyl-2H-isothiazol-3-one"[URL]
- "5-Chloro-2-methyl-4-isothiazolin-3-one:GHS Classification"[URL]
- 최예용, "가습기살균제 참사의 진행과 교훈(Q&A)", 한국환경보건학회지, 43(1), pp.1~22 (2017), 한국환경보건학회
- Interim report of epidemiologic investigation of lung injury with unknown causes in Korea, "Korea Centers for Disease Control and Prevention", KCDC, 817~818 (2011)
- Korea Ministry of Environment, (2019), Korea Ministry of Environment
- 박동욱, "가습기 살균제 피해자 호흡기로 흡입된 가습기 살균제 양 추정 - 호흡기 외부(external) 및 내부 노출(internal exposure) 추정 방법과 사례 -", 한국환경보건학회지, 42(3), pp.141~146 (2016), 한국환경보건학회
- Park DU, "Characteristics of Exposure to Chloromethylisothiazolinone (CMIT) and Methylisothiazolinone (MIT) among humidifier disinfectantassociated lung injury (HDLI) patients in South Korea", Molecules, 25(22), pp.E5284~ (2020)
- Analysis of components of disinfectant contained in humidifier disinfectant products, "Special Committee for Examining the Cause of Tragedy caused by Humidifier Disinfectant", ~ (2020)
- "US Environmental Protection Agency (EPA) Registation eligibility decision(RED) Methylisothiazolinone, EPA738-R98-012" (1998)[URL]
- Lee JH, "Fatal misuse of humidifier disinfectants in Korea : Importance of screening risk assessment and implications for management of chemicals in consumer products", Environmental Science & Technology, 46(5), pp.2498~2500 (2012)
- Quantitative exposure assessment: Stephen Rappaport 2008, "Rappaport SM", ~ (2008)
- UEEP, "Approaches for the application of physiologically based pharmacokinetic (PBPK)models and supporting data in risk assessment" (2006)
- Bourke SJ, "Occupational asthma in an isothiazolinone manufacturing plant", Thorax, 52(8), pp.746~748 (1997)
- Korea Institute of Toxiocology, "Development of inhalation toxicity evaluation and attribution techniques for identifying humidifier disinfectants damage" (2018), Korea Environmental Industry &Technology Institute
- 이소연, "The Pathological Findings of Chloromethylisothiazolinone and Methylisothiazolinone-associated Lung Injury", Journal of Korean Medical Science, 34(14), pp.1~3 (2019), 대한의학회
- 이은, "Two Cases of Chloromethylisothiazolinone and Methylisothiazolinone-associated Toxic Lung Injury", Journal of Korean Medical Science, 33(16), pp.1~8 (2018), 대한의학회
- Cho HJ, "Effects of a mixture of chloromethylisothiazolinone and methylisothiazolinone on peripheral airway dysfunction in children", PLOS ONE, 12(4), pp.e0176083~ (2017)
- Schettgen T, "Quantification of N-methylmalonamic acid in urine as metabolite of the biocides methylisothiazolinone and chloromethylisothiazolinone using gas chromatography-tandem mass spectrometry", Journal of Chromatography B, 1044, pp.185~193 (2017)
- Schettgen T, "Urinary excretion kinetics of the metabolite N-methylmalonamic acid(NMMA)after oral dosage of chloromethylisothiazolinone and methylisothiazolinone in human volunteers", Archives of Toxicology, 91(12), pp.3835~3841 (2017)
- Debethizy J, "Absorption and disposition of 14C-labelled Kathon® biocide, a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl4-isothiazolin-3-one, following intravenous or dermal administration to male Sprague-Dawley rats", Food and Chemical Toxicology, 24(1), pp.43~49 (1986)
- Daftary AS, "Inhalational lung injury associated with humidifier"white dust"", Pediatrics, 127(2), pp.e509~e512 (2011)
- "Environmental fate & pathways: Reaction mass of 2-methyl2H-isothiazol-3-one and 5-chloro-2-methyl-2H-isothiazol-3-one"[URL]
- (2010)[URL]
- (2016)[URL]
- (2015)[URL]
- (2008)[URL]
- (2010)[URL]
- (2017)[URL]
- Kerger BD, "Pathology, toxicology, and latency of irritant gases known to cause bronchiolitis obliterans disease: Does diacetyl fit the pattern?", Toxicology Reports, 2, pp.1463~1472 (2015)
- Filipczak PT, "NOS-2 Inhibition in Phosgene-Induced Acute Lung Injury", Toxicol Sci, 146(1), pp.89~100 (2015)
- Park SK, "Experimental determination of indoor air concentration of 5-chloro-2-methylisothiazol-3(2h)-one", 2-methylisothiazol-3(2h)-one(CMIT, Environmental Health and Toxicology, pp.2020, 35(2)[DOI]
- "The facts about ammonia"[URL]
- Kumar H, "Paraquat poisoning: A case report", J Clin Diagnostic Res., 10(2), pp.OD10~OD11 (2016)
- Seidenfeld JJ, "Paraquat lung injury in rabbits", British Journal of Industrial Medicine, 35(3), pp.245~257 (1978)
- Toxicological Review of Acrolein (CAS No. 107-02-8), "US. Environmental Protection Agency", ~ (2003)
- Borchers MT, "Monocyte inflammation augments acrolein-induced Muc5ac expression in mouse lung", American Journal of Physiology-Lung Cellular and Molecular Physiology, 277(3), pp.L489~497 (1999)
- Van Rooy FGBGJ, "Bronchiolitis obliterans syndrome in chemical workers producing diacetyl for food flavorings", American Journal of Respiratory and Critical Care Medicine, 176(5), pp.498~504 (2007)