Analytical method development and dermal absorption of 2-amino-5-nitrophenol (2A5NP), a hair dye ingredient under oxidative condition

Yu Jin Kim; Hyang Yeon Kim; Jung Dae Lee; Hong Yoon Kim; Jueng Eun Im; Kyu-Bong Kim

doi:10.1007/s43188-022-00159-9

Analytical method development and dermal absorption of 2-amino-5-nitrophenol (2A5NP), a hair dye ingredient under oxidative condition

Toxicol Res. 2022 Dec 13;39(2):231-238. doi: 10.1007/s43188-022-00159-9. eCollection 2023 Apr.

Authors

Yu Jin Kim^{1

2}, Hyang Yeon Kim^{1

2}, Jung Dae Lee^{1

2}, Hong Yoon Kim^{1

2}, Jueng Eun Im^{1

3}, Kyu-Bong Kim^{1

2}

Affiliations

¹ College of Pharmacy, Dankook University, 119 Dandae-Ro, Cheonan, Chungnam 31116 Republic of Korea.
² Center for Human Risk Assessment, Dankook University, 119 Dandae-Ro, Cheonan, Chungnam 31116 Republic of Korea.
³ Medical AI Research Team, Chungbuk National University Hospital, Cheongju, Chungbuk 28644 Republic of Korea.

Abstract

Although 2-amino-5-nitrophenol (2A5NP) is one of the ingredients of hair dye, there has been no information on the dermal absorption rate of 2A5NP. 2A5NP is managed at less than 1.5% in Korea and Japan. In this study, analytical methods were developed and validated using high-performance liquid chromatography (HPLC) in various matrices of wash, swab, stratum corneum (SC), skin (dermis + epidermis), and receptor fluid (RF). Validation results were acceptable based on Korea Ministry of Food and Drug Safety (MFDS) guideline. The HPLC analysis showed a good linearity (r² = 0.9992-0.9999), a high accuracy (93.1-110.2%), and a good precision (1.1-8.1%) in accordance with the validation guideline. Franz diffusion cell was used to determine dermal absorption of 2A5NP using mini pig skin. 2A5NP (1.5%) was applied to skin at 10 μl/cm². For certain cosmetic ingredients such as hair dye with short exposure time, an interim wash step (after 30 min) was added during the study. After application for 30 min and 24 h, skin was wiped off with swab and SC was collected using tape stripping. RF was sampled at 0, 1, 2, 4, 8, 12, and 24 h. Total dermal absorption rate of 2A5NP (1.5%) was determined to be 13.6 ± 2.9%.

Keywords: 2-Amino-5-nitrophenol (2A5NP); Dermal absorption; Franz diffusion cell; Hair dye; High performance liquid chromatography (HPLC).

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