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

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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%.

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Data availability

All data generated or analysed during this study are included in this published article.

Abbreviations

2A5NP:

2-Amino-5-nitrophenol

ACN:

Acetonitrile

CV:

Coefficient of variation

DW:

Distilled water

FDCA:

US Federal Food, Drug and Cosmetic Act

HOQ:

High of quantification

HPLC:

High-performance liquid chromatography

Js:

Equilibrium flux

LLOQ:

Lower limit of quantitation

LOQ:

Limit of quantification

MFDS:

Ministry of Food and Drug safety

MOQ:

Minimum of quantification

NOAEL:

No observed adverse effect level

PEG:

Polyethylene glycol

PTFE:

Polytetrafluoroethylene

RF:

Receptor fluid

SC:

Stratum corneum

SED:

Systemic exposure dose

TFA:

Trifluoroacetic acid

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Acknowledgements

This work was supported by Grants (19172MFDS221 and 22202MFDS158) from the Ministry of Food and Drug Safety, Republic of Korea in 2019 and 2022. 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).

Funding

This work was supported by Grants (19172MFDS221 and 22202MFDS158) from the Ministry of Food and Drug Safety, Republic of Korea in 2019 and 2022. 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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Authors and Affiliations

  1. College of Pharmacy, Dankook University, 119 Dandae-Ro, Cheonan, Chungnam, 31116, Republic of Korea

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

  2. Center for Human Risk Assessment, Dankook University, 119 Dandae-Ro, Cheonan, Chungnam, 31116, Republic of Korea

    Yu Jin Kim, Hyang Yeon Kim, Jung Dae Lee, Hong Yoon Kim & Kyu-Bong Kim

  3. Medical AI Research Team, Chungbuk National University Hospital, Cheongju, Chungbuk, 28644, Republic of Korea

    Jueng Eun Im

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Contributions

All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by YJK, HYK, JEI, HYK and JDL. Writing-original draft preparation was performed YJK. And writing-review, editing and supervision were performed K-BK. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Kyu-Bong Kim.

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Kim, Y.J., Kim, H.Y., Lee, J.D. et al. Analytical method development and dermal absorption of 2-amino-5-nitrophenol (2A5NP), a hair dye ingredient under oxidative condition. Toxicol Res. 39, 231–238 (2023). https://doi.org/10.1007/s43188-022-00159-9

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  • DOI: https://doi.org/10.1007/s43188-022-00159-9

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