Risk assessment of 5-chloro-2-methylisothiazol-3(2H)-one/ 2-methylisothiazol-3(2H)-one (CMIT/MIT) used as a preservative in cosmeticsopen access
- Authors
- Kim, M.K.[Kim, M.K.]; Kim, K.-B.[Kim, K.-B.]; Lee, J.Y.[Lee, J.Y.]; Kwack, S.J.[Kwack, S.J.]; Kwon, Y.C.[Kwon, Y.C.]; Kang, J.S.[Kang, J.S.]; Kim, H.S.[Kim, H.S.]; Lee, B.-M.[Lee, B.-M.]
- Issue Date
- Apr-2019
- Publisher
- Korean Society of Toxicology
- Keywords
- CMIT/MIT; Cosmetics; Margin of safety; Preservative; Risk assessment; Skin sensitization
- Citation
- Toxicological Research, v.35, no.2, pp.103 - 117
- Indexed
- SCOPUS
KCI
- Journal Title
- Toxicological Research
- Volume
- 35
- Number
- 2
- Start Page
- 103
- End Page
- 117
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/15354
- DOI
- 10.5487/TR.2019.35.2.103
- ISSN
- 1976-8257
- Abstract
- The mixture of 5-chloro-2-methylisothiazol-3(2H)-one (CMIT) and 2-methylisothiazol-3(2H)-one (MIT), CMIT/ MIT, is a preservative in cosmetics. CMIT/MIT is a highly effective preservative; however, it is also a commonly known skin sensitizer. Therefore, in the present study, a risk assessment for safety management of CMIT/MIT was conducted on products containing 0.0015% of CMIT/MIT, which is the maximum MIT level allowed in current products. The no observed adverse effect level (NOAEL) for CMIT/MIT was 2.8 mg/kg bw/day obtained from a two-generation reproductive toxicity test, and the skin sensitization toxicity standard value for CMIT/MIT, or the no expected sensitization induction level (NESIL), was 1.25 μg/cm 2 /day in humans. According to a calculation of body exposure to cosmetics use, the systemic exposure dosage (SED) was calculated as 0.00423 mg/kg bw/day when leave-on and rinse-off products were considered. Additionally, the consumer exposure level (CEL) amounted to 0.77512 μg/cm 2 /day for all representative cosmetics and 0.00584 μg/cm 2 /day for rinse-off products only. As a result, the non-cancer margin of safety (MOS) was calculated as 633, and CMIT/MIT was determined to be safe when all representative cosmetics were evaluated. In addition, the skin sensitization acceptable exposure level (AEL)/CEL was calculated as 0.00538 for all representative cosmetics and 2.14225 for rinse-off products; thus, CMIT/MIT was considered a skin sensitizer when all representative cosmetics were evaluated. Current regulations indicate that CMIT/MIT can only be used at concentrations 0.0015% or less and is prohibited from use in other cosmetics products. According to the results of this risk assessment, the CMIT/MIT regulatory values currently used in cosmetics are evaluated as appropriate. © Korean Society of Toxicology.
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