DOI QR코드

DOI QR Code

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

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).

References

  1. Fitzpatrick LR, Woldemariam T (2017) Cancer, immunology and inflammation, and infectious disease. In: Comprehensive medicinal chemistry III. pp 495-510
  2. Kahkeshani N, Farzaei F, Fotouhi M, Alavi SS, Bahramsoltani R, Naseri R, Momtaz S, Abbasabadi Z, Rahimi R, Farzaei MH (2019) Pharmacological effects of gallic acid in health and diseases: a mechanistic review. Iran J Basic Med Sci 22:225. https://doi.org/10.22038/ijbms.2019.32806.7897
  3. Borde VU, Pangrikar PP, Tekale SU (2011) Gallic acid in ayurvedic herbs and formulations. Recent Res Sci Technol 3:51-54. https://core.ac.uk/download/pdf/236009124.pdf
  4. Goldberg I, Rokem JS (2009) Organic and fatty acid production, microbial. In: Schaechter M (ed) Encyclopedia of microbiology, 3rd edn. Academic Press, Oxford, pp 421-442
  5. Sankar J, Sawarkar S, Malsnkar J, Rawat BS, Ali MA (2017) Review: mechanism of hair dying and their safety aspects. Res J Top Cosm Sci 8:72-77. https://doi.org/10.5958/2321-5844.2017.00009.7
  6. Poet TS, Mcdougal JN (2002) Skin absorption and human risk assessment. Chem Biol Interact 140:19-34. https://doi.org/10.1016/s0009-2797(02)00013-3
  7. Lee Y, Kim H, Pham Q, Lee J, Kim K (2022) Pharmacokinetics and the dermal absorption of bromochlorophene, a cosmetic preservative ingredient. Rats Toxics 10:329. https://doi.org/10.3390/toxics10060329
  8. Sreedhar D, Manjula N, Pise SA, Ligade V (2020) Ban of cosmetic testing on animals: a brief overview. Int J Curr Res Rev 12:113. https://doi.org/10.31782/IJCRR.2020.121424
  9. Kim SW, Kim B (2016) A web-based alternative non-animal method database for safety cosmetic evaluations. Toxicol Res 32:259-267. https://doi.org/10.5487/tr.2016.32.3.259
  10. MFDS (Ministry of Food and Drug Safety) (2009) Guideline for in vitro skin absorption method. B1-2009-4-001. http://www.mfds.go.kr/index.do?x=0&searchkey=title:contents&mid=1161&searchword=&pageNo=78&seq=4788&cmd=v. Accessed 03 Apr 2024
  11. Cilurzo F, Minghetti P, Sinico C (2007) Newborn pig skin as model membrane in in vitro drug permeation studies: a technical note. AAPS PharmSciTech 8:97-100. https://doi.org/10.1208%2Fpt0804094 https://doi.org/10.1208%2Fpt0804094
  12. Dick IP, Scott RC (1992) Pig ear skin as an in-vitro model for human skin permeability. J Pharm Pharmacol 44:640-645. https://doi.org/10.1111/j.2042-7158.1992.tb05485.x
  13. Singh S, Zhao K, Singh J (2002) In vitro permeability and binding of hydrocarbons in pig ear and human abdominal skin. Drug Chem Toxicol 25:83-92. https://doi.org/10.1081/dct-100108474
  14. MFDS (Ministry of Food and Drug Safety) (2013) Guidelines for validation of bio-sampling methods. http://www.mfds.go.kr/index.do?mid=687andpageNo=2andseq=8003andcmd=v. Accessed 03 Apr 2024
  15. OECD (Organisation for Economic Cooperation and Development) (2004) Guideline for the testing of chemicals skin absorption: in vitro method. 427. https://ntp.niehs.nih.gov/iccvam/suppdocs/feddocs/oecd/oecdtg428-508.pdf. Accessed 03 Apr 2024
  16. MFDS (The Ministry of Food and Drug Safety) (2014) Regulations on cosmetic safety standards. Ministry of Food and Drug Safety 2014-118 issue. http://www.mfds.go.kr/index.do?mid=687andpageNo=2andseq=8003andcmd=v. Accessed 03 Apr 2024
  17. SCCP (Scientific Committee on Consumer Products) (2009) Opinion on Intermediates and reaction products of oxidative hair dye ingredients formed during hair dyeing. https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_037.pdf. Accessed 03 Apr 2024
  18. SCCS (The Scientifc Committee on Consumer Safety) (2010) Opinion on basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients. SCCS/1358/10. Updated 22 June 2010. https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_002.pdf
  19. Lee JD, Kim JY, Jang HJ, Lee BM, Kim KB (2019) Percutaneous permeability of 1-phenoxy-2-propanol, a preservative in cosmetics. Regul Toxicol Pharmacol 103:56-62. https://doi.org/10.1016/j.yrtph.2019.01.002
  20. WHO (World Health Organization) (2006) Dermal absorption. World Health Organization. https://apps.who.int/iris/handle/10665/43542. Accessed 03 Apr 2024
  21. Soto ML, Falque E, Dominguez H (2015) Relevance of natural phenolics from grape and derivative products in the formulation of cosmetics. Cosmetics 2:259-276. https://doi.org/10.3390/cosmetics2030259
  22. Khan BA, Mahmood T, Menaa F, Shahzad Y, Yousaf AM, Hussain T, Ray SD (2018) New perspectives on the efficacy of gallic acid in cosmetics & nanocosmeceuticals. Curr Pharm Des 24:5181-5187. https://doi.org/10.2174/1381612825666190118150614
  23. Song R, Cheng Y, Tian Y, Zhang Z (2012) A validated solid-phase extraction HPLC method for the simultaneous determination of gallic acid, catechin and epicatechin in rhubarb decoction. Chin J Nat Med 10:275-278. https://doi.org/10.1016/S1875-5364(12)60055-7
  24. Alonso C, Lucas R, Barba C, Marti M, Rubio L, Comelles F, Moralfs JC, Ccderch L, Parra JL (2015) Skin delivery of antioxidant surfactants based on gallic acid and hydroxytyrosol. J Pharm Pharmacol 67:900-908. https://doi.org/10.1111/jphp.12382
  25. Steiling W, Kreutz J, Hofer H (2001) Percutaneous penetration/dermal absorption of hair dyes in vitro. Toxicol In Vitro 15:565-570. https://doi.org/10.1016/s0887-2333(01)00062-5
  26. Hofer H, Hruby E (1983) Skin penetration by 2, 4-diaminoanisole in the rat. Food Chem Toxicol 21:331-334. https://doi.org/10.1016/0278-6915(83)90069-8
  27. Singh AK (2016) Chapter 6-nanoparticle pharmacokinetics and toxicokinetics. In: Singh AK (ed) Engineered nanoparticles, pp 229-293
  28. PubChem (2021) Chemical and physical properties of gallic acid. https://pubchem.ncbi.nlm.nih.gov/compound/Gallic-acid. Accessed 03 Apr 2024