In vitro dermal absorption and metabolism of D&C red no. 17 in human and porcineskin. 2007

Jeffrey Yourick, and Camille Sasik, and Robert L Bronaugh
Office of Cosmetics and Colors, US Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, USA.

D&C red no. 17 is approved for use in externally applied drug and cosmetic applications, in amounts consistent with good manufacturing practice. Concerns about the safety of the color additive (1-[4-phenylazophenylazo]-2-napthol (PAN) is the primary color constituent) have been raised due to potential metabolic cleavage of PAN to yield 4-aminoazobenzene. (14)C-PAN was applied in a commercially available suntan vehicle containing D&C red no. 17 to viable porcine and non-viable (cadaver) human skin in flow-through diffusion cells. At the end of 24 h, unabsorbed material was removed from the skin and some cells were allowed to continue for an additional 48 h. In human skin, 0.07% and 0.17% of the applied dose were absorbed into the receptor fluid after 24 and 72 h, respectively. At the end of 24 h, 12.5% of the applied dose remained in the skin, which did not decrease at 72 h. When PAN was applied to viable porcine skin for 24 h, 0.3% of the applied dose was absorbed and 12.7% remained in the skin. Additional studies to simulate short-term exposure were completed with PAN applied to the skin for only 15 min, and absorption was determined for 24 and 72 h. These studies in human cadaver skin found 0.02% and 0.08% of the applied dose in the receptor fluid after 24 and 72 h, respectively. Viable porcine skin studies with the 15-min application resulted in receptor fluid values of 0.1% of the applied dose after 24 h. Lipophilic receptor fluids composed of the non-ionic surfactant Volpo 20 at wt% concentrations of 1%, 3%, or 6% in water did not increase partitioning of PAN from the skin into the receptor fluid. No metabolism of PAN was found in viable porcine skin when examined by HPLC. In conclusion, skin absorption of PAN from a commercially available suntan product was low.

UI MeSH Term Description Entries
D009284 Naphthols Naphthalene derivatives carrying one or more hydroxyl (-OH) groups at any ring position. They are often used in dyes and pigments, as antioxidants for rubber, fats, and oils, as insecticides, in pharmaceuticals, and in numerous other applications. Hydroxynaphthalene,Hydroxynaphthalenes,Naphthol
D003358 Cosmetics Substances intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product. (U.S. Food & Drug Administration Center for Food Safety & Applied Nutrition Office of Cosmetics Fact Sheet (web page) Feb 1995) Personal Care Products,Care Product, Personal,Care Products, Personal,Personal Care Product,Product, Personal Care,Products, Personal Care
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000279 Administration, Cutaneous The application of suitable drug dosage forms to the skin for either local or systemic effects. Cutaneous Drug Administration,Dermal Drug Administration,Drug Administration, Dermal,Percutaneous Administration,Skin Drug Administration,Transcutaneous Administration,Transdermal Administration,Administration, Dermal,Administration, Transcutaneous,Administration, Transdermal,Cutaneous Administration,Cutaneous Administration, Drug,Dermal Administration,Drug Administration, Cutaneous,Skin Administration, Drug,Administration, Cutaneous Drug,Administration, Dermal Drug,Administration, Percutaneous,Administrations, Cutaneous,Administrations, Cutaneous Drug,Administrations, Dermal,Administrations, Dermal Drug,Administrations, Percutaneous,Administrations, Transcutaneous,Administrations, Transdermal,Cutaneous Administrations,Cutaneous Administrations, Drug,Cutaneous Drug Administrations,Dermal Administrations,Dermal Drug Administrations,Drug Administrations, Cutaneous,Drug Administrations, Dermal,Drug Skin Administrations,Percutaneous Administrations,Skin Administrations, Drug,Skin Drug Administrations,Transcutaneous Administrations,Transdermal Administrations
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001391 Azo Compounds Organic chemicals where aryl or alkyl groups are joined by two nitrogen atoms through a double bond (R-N Azo Dye,Azo Dyes,Compounds, Azo,Dye, Azo,Dyes, Azo
D012867 Skin The outer covering of the body that protects it from the environment. It is composed of the DERMIS and the EPIDERMIS.
D012869 Skin Absorption Uptake of substances through the SKIN. Absorption, Skin,Intracutaneous Absorption,Intradermal Absorption,Percutaneous Absorption,Transcutaneous Absorption,Transdermal Absorption,Absorption, Intracutaneous,Absorption, Intradermal,Absorption, Percutaneous,Absorption, Transcutaneous,Absorption, Transdermal,Absorptions, Intracutaneous,Absorptions, Intradermal,Absorptions, Percutaneous,Absorptions, Skin,Absorptions, Transcutaneous,Absorptions, Transdermal,Intracutaneous Absorptions,Intradermal Absorptions,Percutaneous Absorptions,Skin Absorptions,Transcutaneous Absorptions,Transdermal Absorptions
D013552 Swine Any of various animals that constitute the family Suidae and comprise stout-bodied, short-legged omnivorous mammals with thick skin, usually covered with coarse bristles, a rather long mobile snout, and small tail. Included are the genera Babyrousa, Phacochoerus (wart hogs), and Sus, the latter containing the domestic pig (see SUS SCROFA). Phacochoerus,Pigs,Suidae,Warthogs,Wart Hogs,Hog, Wart,Hogs, Wart,Wart Hog
D066298 In Vitro Techniques Methods to study reactions or processes taking place in an artificial environment outside the living organism. In Vitro Test,In Vitro Testing,In Vitro Tests,In Vitro as Topic,In Vitro,In Vitro Technique,In Vitro Testings,Technique, In Vitro,Techniques, In Vitro,Test, In Vitro,Testing, In Vitro,Testings, In Vitro,Tests, In Vitro,Vitro Testing, In

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