In vitro human skin penetration of diethanolamine.
Concerns about the safety of diethanolamine (DEA) have been raised by the National Toxicology Program (NTP). Therefore, we measured the extent of DEA absorption in human skin relevant to exposures from shampoos, hair dyes and body lotions. Radiolabeled [14C]-DEA was added to two commercial products from each class and applied to excised viable and non-viable human skin in flow-through diffusion cells. The products remained on the skin for 5, 30 and 24 h for shampoos, hair dyes and body lotions, respectively. After 24 h, most of the absorbed dose was found in skin: 2.8% for shampoos, 2.9% for hair dyes and 10.0% for body lotions. Only small amounts were absorbed into the receptor fluid: 0.08%, 0.09% and 0.9% for shampoos, hair dyes and body lotions respectively. There was no significant difference in the absorption of DEA through viable and non-viable skin or from product application doses of 1, 2 or 3 mg lotion/cm2. In 72 h daily repeat dose studies with a lotion, DEA appeared to accumulate in the skin (29.2%) with little diffusing out into the receptor fluid. Therefore, skin levels of DEA should not be included in estimates of systemic absorption used in exposure assessments.
Office of Cosmetics and Colors, US Food and Drug Administration, BRF HFS-128, 8301 Muirkirk Rd, Laurel, MD 20708, USA. margaret.kraeling@cfsan.fda.gov
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Kraeling
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Yourick
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Bronaugh
D001711:Biotransformation; D003358:Cosmetics; D020405:Dermis / Q000378:metabolism; D015194:Diffusion Chambers, Culture; D004817:Epidermis / Q000378:metabolism; D004983:Ethanolamines / Q000493:pharmacokinetics*; D006202:Hair Dyes; D006801:Humans; D066298:In Vitro Techniques; D011485:Protein Binding; D012869:Skin Absorption; D012915:Soaps
D003358:Cosmetics; D004983:Ethanolamines; D006202:Hair Dyes; D012915:Soaps; C020283:diethanolamine