Transdermal absorption of ethanol- and 1-propanol-containing hand disinfectants.
OBJECTIVE
Ethanol- or 1-propanol-containing hand disinfectants are widely used as surgical hand antisepsis. The primary objective of this study was to investigate transdermal absorption of ethanol and 1-propanol from combination of 45% ethanol and 18% 1-propanol with skin protecting ingredients (Softa-Man®) within 1 h after application in comparison to the absorption of these alcohols from the product in the absence of the cosmetic additives. The secondary objective was to evaluate the dermal tolerability.


METHODS
Following the double-blind, randomized cross-over design for this clinical trial, 20 ml of two different alcohol-containing disinfectants was applied with a 200-cm(2) gauze swab on a skin area, identical in size and location, of 14 healthy volunteers for 10 min to investigate the absorption rate of ethanol and 1-propanol. Local dermal tolerability was evaluated using a four-point erythema scale.


RESULTS
No clinically relevant dermal absorption, with respect to ethanol and 1-propanol, could be observed within 1 h after application. Disinfectant-related mild local skin erythema was observed in three cases.


CONCLUSIONS
The use of the tested formulations containing ethanol and 1-propanol can be considered as safe. The tested formulation containing skin protecting additives (Softa-Man®) does not result in more alcoholic absorption than the formulation without protective additives.
Department of Surgery, University of Munich, Klinikum Großhadern, Marchioninistr. 15, 81377 Munich, Germany. Reinhold.Lang@med.uni-muenchen.de
Reinhold Andreas
RA
Lang
Dianne
D
Egli-Gany
Florian Holger Hubert
FH
Brill
Johannes Georg
JG
Böttrich
Marion
M
Breuer
Burkhard
B
Breuer
Martin Hartwig
MH
Kirschner
D000433:1-Propanol / Q000493:pharmacokinetics* / Q000494:pharmacology; D000328:Adult; D000886:Anthropometry; D000891:Anti-Infective Agents, Local / Q000493:pharmacokinetics* / Q000494:pharmacology; D015992:Body Mass Index; D018592:Cross-Over Studies; D004311:Double-Blind Method; D000431:Ethanol / Q000493:pharmacokinetics* / Q000494:pharmacology; D006235:Hand Disinfection / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D012869:Skin Absorption / Q000187:drug effects*; D055815:Young Adult
D000891:Anti-Infective Agents, Local; D000431:Ethanol; D000433:1-Propanol