Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
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Analytical method development and dermal absorption of gallic acid, a hair dye ingredient

  • Yu Jin Kim (Department of Pharmacy, College of Pharmacy, Dankook University) ;
  • Hyang Yeon Kim (Department of Pharmacy, College of Pharmacy, Dankook University) ;
  • Jung Dae Lee (Department of Pharmacy, College of Pharmacy, Dankook University) ;
  • Hong Yoon Kim (Department of Pharmacy, College of Pharmacy, Dankook University) ;
  • Jueng‑Eun Im (Department of Pharmacy, College of Pharmacy, Dankook University) ;
  • Kyu‑Bong Kim (Department of Pharmacy, College of Pharmacy, Dankook University)
  • Received : 2023.12.20
  • Accepted : 2024.03.07
  • Published : 2024.07.15
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Abstract

Gallic acid (GA) is a phenolic compound known as 3,4,5-trihydroxybenzoic acid. GA is used as a hair dye ingredient. It is limited to be below 4.0% in Korea. Dermal absorption rate of GA has not been reported yet. In this study, an analytical method for GA was developed and validated using high-performance liquid chromatography (HPLC) in various matrices of swab, stratum corneum (SC), skin (dermis+epidermis), and receptor fuid (RF). HPLC analysis showed acceptable linearity (r2=0.999-0.9998), accuracy (90.3-112.8%), and precision (0.7-13.6%) in accordance with validation guidelines by Korea Ministry of Food and Drug Safety (MFDS). The dermal absorption rate of GA was determined using Franz diffuse cells. GA (4.0%) was applied to mini pig skin of 10 µl/cm2. After 30 min application, the GA was wiped out and receptor fluid sampling was continued until 24 h. After 24 h, skin was wiped of with swab and SC was collected using tape stripping. All samples were extracted with ethanol and analyzed using the validated method. The total dermal absorption rate of GA was determined to be 2.6±1.3% (24 h).

Keywords

Acknowledgement

This work was supported by grants (19172MFDS221 and 22202MFDS158) from the Ministry of Food and Drug Safety, Republic of Korea. This work was supported by the Korea Environment Industry & Technology Institute (KEITI) through the Technology Program for Establishing Biocide Safety Management, funded by the Korea Environment (MOE) (2021002970001, 1485017976).

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