Systemic absorption of benzalkonium chloride after maximal use of a consumer antiseptic wash product.

An in vivo pharmacokinetic study was conducted using consumer antiseptic wash containing 0.13% benzalkonium chloride (BAC) to assess the effect of dermal absorption on long-term systemic exposure to BAC. The objective of the study was to determine blood levels of BAC under maximal use conditions. Subjects were enlisted to wash their hands 60 s with soap containing 0.13% BAC 30 times per day over an 8-9 h time period for 5 consecutive days. The test product with the highest absorption potential was selected based on market share and results from in vitro permeation testing. Blood plasma was collected from subjects on 32 occasions over the 6-day study period. Plasma samples were analyzed for the C12 and C14 homologs of BAC using LC-MS/MS with a lower limit of quantitation (LLOQ) of 106.9 and 32.6 ng/L, respectively. For the 32 subjects, C12 homolog was detected above the LLOQ in only four of 1,024 plasma samples at 117.8-191.7 ng/L, and C14 homolog was detected in only one sample at 59.5 ng/L. Consequently, systemic exposure to BAC in antimicrobial soap is very low and below the level of concern identified by the U.S. Food and Drug Administration (500 ng/L) even under maximal use conditions.

Effects of soap-water wash on human epidermal penetration.

Skin decontamination is a primary interventional method used to decrease dermal absorption of hazardous contaminants, including chemical warfare agents, pesticides and industrial pollutants. Soap and water wash, the most common and readily available decontamination system, may enhance percutaneous absorption through the "wash-in effect." To understand better the effect of soap-water wash on percutaneous penetration, and provide insight to improving skin decontamination methods, in vitro human epidermal penetration rates of four C(14) -labeled model chemicals (hydroquinone, clonidine, benzoic acid and paraoxon) were assayed using flow-through diffusion cells. Stratum corneum (SC) absorption rates of these chemicals at various hydration levels (0-295% of the dry SC weights) were determined and compared with the results of the epidermal penetration study to clarify the effect of SC hydration on skin permeability. Results showed accelerated penetration curves of benzoic acid and paraoxon after surface wash at 30 min postdosing. Thirty minutes after washing (60 min postdosing), penetration rates of hydroquinone and benzoic acid decreased due to reduced amounts of chemical on the skin surface and in the SC. At the end of the experiment (90 min postdosing), a soap-water wash resulted in lower hydroquinone penetration, greater paraoxon penetration and similar levels of benzoic acid and clonidine penetration compared to penetration levels in the non-wash groups. The observed wash-in effect agrees with the enhancement effect of SC hydration on the SC chemical absorption rate. These results suggest SC hydration derived from surface wash to be one cause of the wash-in effect. Further, the occurrence of a wash-in effect is dependent on chemical identity and elapsed time between exposure and onset of decontamination. By reducing chemical residue quantity on skin surface and in the SC reservoir, the soap-water wash may decrease the total quantity of chemical absorbed in the long term; however, the more immediate accelerated absorption of chemical toxins, particularly chemical warfare agents, may be lethal. Copyright © 2015 John Wiley & Sons, Ltd.

Visual analysis of vaginal cell binding and retention of a gynecological douche.

AIM: Gynecological douches may contain various molecules that need to cover and be retained by cutaneous and mucosal cells if they are to act efficaciously in treating local conditions. The aim of this study was to investigate the possibility of directly visualising the ability of a commercial medical gynecological douche to bind to, and be retained by human vaginal cells. METHODS: The commercial gynecological douche under study was "Saugella Attiva douche", bought at local chemist. The vaginal epithelial cells were obtained from healthy, non-pregnant, regularly menstruating women aged 24-52 years. The cells were obtained from the mucosal surface of the mid-vaginal wall by means of gentle scraping with a sterile spatula. Ferric oxide particles and Escherichia coli were used as inorganic and organic markers in order to visualize the adherence of the transparent thin film of a gynecological douche to human vaginal cells by means of Nomarski interference contrast microscopy and scanning electron microscopy. RESULTS: Both markers made it possible to clearly visualize the binding and retention of the transparent thin layer of the douche also at the dilution 1:2 and 1:4. CONCLUSIONS: The fact that the douche can be locally retained is useful because its formulation contains thymol and eugenol, which are known to have antibacterial, antifungal and antioxidant effects but need a period of contact before they act fully.

Absorption of lawsone through human skin.

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.

Dermal absorption of isopropyl alcohol from a commercial hand rub: implications for its use in hand decontamination.

Isopropyl alcohol-containing hand rubs are widely used in healthcare for hand decontamination. Ten healthy adult volunteers applied a commercially available isopropyl alcohol-containing hand rub to their hands every 10 min over a 4 h period. Blood isopropyl alcohol levels were measured at the beginning and end of the study. At the end of the study, measurable blood isopropyl alcohol levels (range 0.5-1.8 mg/l) were recorded in nine subjects. We confirmed that isopropyl alcohol could be absorbed through the intact skin of adult humans. The social and medical implications are discussed.

Colonic cleansing, fluid absorption, and discomfort following tap water and soapsuds enemas.

Tap water and soapsuds are common enema solutions, but little is known about their effectiveness. Consequently, nurses have no guidance when choosing the best enema for a given patient. In this study, liver transplant patients were given either a tap water or soapsuds enema preoperatively. Amount of enema instilled into the colon and output were measured. Soapsuds enemas produced significantly greater output than tap water and were equally well tolerated. Most subjects who received tap water enemas retained more fluid than was eliminated. Based on these findings, nurses should use caution when giving repeated enemas to patients sensitive to large fluid loads.