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© 1993 Oxford University Press

research-article

Percutaneous Penetration of N-Nitrosodiethanolamine through Human Skin (in Vitro): Comparison of Finite and Infinite Dose Applications from Cosmetic Vehicles

THOMAS J. FRANZ*,1, PAUL A. LEHMAN*, SUSAN F. FRANZ*, HELEN NORTH-ROOT{dagger}, JANIS L. DEMETRULIAS{dagger}, CHRISTOPHER K. KELLING{ddagger}, STEPHEN J. MOLONEY§ and STEPHEN D. GETTINGS

*University of Arkansas for Medical Sciences Little Rock, Arkansas 72205 {dagger}The Dial Corporation Scottsdale, Arizona 85254 {ddagger}The Procter & Gamble Company Cincinnati, Ohio 45241 §Schering-Plough Health Care Products Inc. Memphis, Tennessee 38151 ¶The Cosmetic, Toiletry and Fragrance Association Washington, D.C. 20036

Received September 3, 1992; accepted April 26, 1993

N-Nitroso compounds (nitrosamines) have been detected at the parts per billion level in a wide variety of matrices including industrial chemicals, pharmaceuticals, and food. Although N-nitrosodiethanolamine (NDELA) may be detected as an impurity in some cosmetic products, studies on NDELA absorption through human skin have been limited. A study to determine the extent of NDELA absorption following topical application was therefore undertaken to assist in the proper assessment of risk following unintended exposure. NDELA absorption was measured in vitro through human cadaver skin using isopropyl myristate (IPM) and generic prototype personal-care formulations (sunscreen and shampoo) spiked with [14C]NDELA. When applied as a finite dose at a concentration of 0.06% or lower, NDELA absorption was found to be a linear function of concentration. Total absorption at 48 hr ranged from approximately 35 to 65% of the dose and was formulation dependent (IPM>shampoo≥sunscreen). Absorption occurred relatively rapidly from all formulations and peak rates of absorption were seen within the first 5 hr from the IPM and shampoo formulations. When applied as an infinite dose, total NDELA absorption followed a different rank order (shampoo ≥IPM>sunscreen) and evidence of barrier damage was seen with the shampoo formulation.


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