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Analytical Method Development and Dermal Absorption of 4-Amino-3-Nitrophenol (4A3NP), a Hair Dye Ingredient under the Oxidative or Non-Oxidative Condition.
Kim, Hyang Yeon; Kim, Yu Jin; Lee, Jung Dae; Kim, Hak Rim; Seo, Dong-Wan.
Afiliación
  • Kim HY; College of Pharmacy and Center for Human Risk Assessment, Dankook University, 119 Dandae-ro, Cheonan 31116, Chungnam, Republic of Korea.
  • Kim YJ; Center for Human Risk Assessment, Dankook University, Cheonan 31116, Chungnam, Republic of Korea.
  • Lee JD; College of Pharmacy and Center for Human Risk Assessment, Dankook University, 119 Dandae-ro, Cheonan 31116, Chungnam, Republic of Korea.
  • Kim HR; College of Pharmacy and Center for Human Risk Assessment, Dankook University, 119 Dandae-ro, Cheonan 31116, Chungnam, Republic of Korea.
  • Seo DW; Center for Human Risk Assessment, Dankook University, Cheonan 31116, Chungnam, Republic of Korea.
Toxics ; 12(5)2024 May 07.
Article en En | MEDLINE | ID: mdl-38787119
ABSTRACT
The chemical 4-amino-3-nitrophenol (4A3NP) is classified as an amino nitrophenol and is primarily utilized as an ingredient in hair dye colorants. In Korea and Europe, it is exclusively used in non-oxidative or oxidative hair dye formulations, with maximum allowable concentrations of 1% and 1.5%, respectively. Despite this widespread use, risk assessment of 4A3NP has not been completed due to the lack of proper dermal absorption data. Therefore, in this study, both the analytical method validation and in vitro dermal absorption study of 4A3NP were conducted following the guidelines provided by the Korea Ministry of Food and Drug Safety (MFDS). Before proceeding with the dermal absorption study, analytical methods were developed for the quantitation of 4A3NP through multiple reaction monitoring (MRM) via liquid chromatography-mass spectrometry (LC-MS) in various matrices, including swab wash (WASH), stratum corneum (SC), skin (SKIN, comprising the dermis and epidermis), and receptor fluid (RF). These developed methods demonstrated excellent linearity (R2 = 0.9962-0.9993), accuracy (93.5-111.73%), and precision (1.7-14.46%) in accordance with the validation guidelines.The dermal absorption of 4A3NP was determined using Franz diffusion cells with mini-pig skin as the barrier. Under both non-oxidative and oxidative (6% hydrogen peroxide (H2O2) water, 11) hair dye conditions, 1% and 1.5% concentrations of 4A3NP were applied to the skin at a rate of 10 µL/cm2, respectively. The total dermal absorption rates of 4A3NP under non-oxidative (1%) and oxidative (1.5%) conditions were determined to be 5.62 ± 2.19% (5.62 ± 2.19 µg/cm2) and 2.83 ± 1.48% (4.24 ± 2.21 µg/cm2), respectively.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Toxics Año: 2024 Tipo del documento: Article Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Toxics Año: 2024 Tipo del documento: Article Pais de publicación: Suiza