title: Absorption of lawsone through human skin.
abstract: Lawsone (2-hydroxy-1,4-naphthoquinone) is the principal color ingredient in henna, a color additive approved with limitations for coloring hair by the Food and Drug Administration (FDA) under 21 CFR 73.2190. In 2002, the scientific committee on cosmetics and non-food products (SCCNFP), now known as the scientific committee for consumer products (SCCP), evaluated the safety of lawsone as a coloring agent in hair dye products of the European Union (EU). The SCCNFP concluded that lawsone was mutagenic and not suitable for use as a hair coloring agent. As a result, studies were conducted to measure the extent of lawsone absorption through human skin. Lawsone skin absorption was determined from two hair coloring products and two shampoo products, all containing henna. [(14)C]-Lawsone (sp. act. 22.9 mCi/mmol) was added to each commercial product and the products were applied to dermatomed, nonviable human skin mounted in flow-through diffusion cells perfused with a physiological buffer (HEPES-buffered Hanks' balanced salt solution, pH 7.4). Products remained on the skin for 5 minutes (shampoos) and 1 hour (hair color paste). For the henna hair paste products, 0.3 and 1.3% of the applied dose was absorbed into the receptor fluid in 24 hours while 2.2 and 4.0% remained in the skin. For both henna shampoo products, 0.3% of the applied dose was absorbed into the receptor fluid at 24 hours while 3.6 and 6.8% remained in the skin. For all products, most of the lawsone applied was washed from the surface of the skin (83-102%) at the end of the exposure period. Extended absorption studies were conducted for 72 hours to determine if skin levels of lawsone in the 24 hour studies might eventually be percutaneously absorbed. These studies determined that the majority of the lawsone remained in the skin with only a small but significant increase (for three out of four products) in receptor fluid values. Therefore, it appears that receptor fluid values would give a good estimate of lawsone absorption for an exposure estimate and that skin levels of lawsone need not be included.
authors.affiliation: Office of Cosmetics and Colors, US Food and Drug Administration, College Park, MD 20740, USA. margaret.kraeling@fda.hhs.gov
authors.forename: Margaret E K
authors.initials: ME
authors.lastname: Kraeling
authors.forename: Robert L
authors.initials: RL
authors.lastname: Bronaugh
authors.forename: Connie T
authors.initials: CT
authors.lastname: Jung
mesh_terms: D002250:Carbon Radioisotopes; D015194:Diffusion Chambers, Culture / Q000379:methods; D004305:Dose-Response Relationship, Drug; D006202:Hair Dyes / Q000737:chemistry / Q000493:pharmacokinetics; D006801:Humans; D066298:In Vitro Techniques; D009285:Naphthoquinones / Q000737:chemistry / Q000493:pharmacokinetics*; D011208:Powders; D015203:Reproducibility of Results; D012867:Skin / Q000378:metabolism*; D012869:Skin Absorption; D012915:Soaps / Q000737:chemistry / Q000493:pharmacokinetics; D012996:Solutions; D013997:Time Factors
chemical_list: D002250:Carbon Radioisotopes; D006202:Hair Dyes; D009285:Naphthoquinones; D011208:Powders; D012915:Soaps; D012996:Solutions; C005090:lawsone