Safety assessment for ethanol-based topical antiseptic use by health care workers: Evaluation of developmental toxicity potential

Abstract

Ethanol-based topical antiseptic hand rubs, commonly referred to as alcohol-based hand sanitizers (ABHS), are routinely used as the standard of care to reduce the presence of viable bacteria on the skin and are an important element of infection control procedures in the healthcare industry. There are no reported indications of safety concerns associated with the use of these products in the workplace. However, the prevalence of such alcohol-based products in healthcare facilities and safety questions raised by the U.S. FDA led us to assess the potential for developmental toxicity under relevant product-use scenarios. Estimates from a physiologically based pharmacokinetic modeling approach suggest that occupational use of alcohol-based topical antiseptics in the healthcare industry can generate low, detectable concentrations of ethanol in blood. This unintended systemic dose probably reflects contributions from both dermal absorption and inhalation of volatilized product. The resulting internal dose is low, even under hypothetical, worst case intensive use assumptions. A significant margin of exposure (MOE) exists compared to demonstrated effect levels for developmental toxicity under worst case use scenarios, and the MOE is even more significant for typical anticipated occupational use patterns. The estimated internal doses of ethanol from topical application of alcohol-based hand sanitizers are also in the range of those associated with consumption of non-alcoholic beverages (i.e., non-alcoholic beer, flavored water, and orange juice), which are considered safe for consumers. Additionally, the estimated internal doses associated with expected exposure scenarios are below or in the range of the expected internal doses associated with the current occupational exposure limit for ethanol set by the Occupational Safety and Health Administration. These results support the conclusion that there is no significant risk of developmental or reproductive toxicity from repeated occupational exposures and high frequency use of ABHSs or surgical scrubs. Overall, the data support the conclusion that alcohol-based hand sanitizer products are safe for their intended use in hand hygiene as a critical infection prevention strategy in healthcare settings.

The effect of alcohol-based handrub solution on hands skin integrity of health care providers

“…These results indicate that sanitizer solution has suitable compatibility with hand skin, which is consistent with the findings of Zaragoza et al, where the skin condition and tolerability improved by using alcoholic products (19), this result was consistent with the outcomes of Elaine et al They found that skin disorders were less in alcoholic solutions with emollient (20). Also, the results of Maier et al demonstrated that frequent use of alcoholic solutions for hygiene is not a danger for people and it can be one of the best ways to prevent infection (21).…”

Alcohols as Surface Disinfectants in Healthcare Settings

“…48,49 Recent assessments of the exposure of healthcare personnel to alcohol-based hand rubs concluded that such products are safe when used as intended. 49,50 Despite the frequent exposure of healthcare personnel to alcohol-based disinfectants, 48 these products appear to pose little risk to healthcare personnel if used as directed. For example, a review of data from 69,075 full-time work years by healthcare personnel revealed that reported injuries or illnesses due to germicides, including alcohol, were very uncommon.…”

Direct electrospinning of poly(vinyl butyral) onto human dermal fibroblasts using a portable device

“…A review study (Lachenmeier’s ( 2008 )) concluded that ethanol absorption through the wounds via pharmaceutical preparations is not toxic to adults. Furthermore, it was found in another study that a high-frequency use and exposure to alcohol-based hand sanitizers or surgical scrubs for hand and skin hygiene do not cause significant risks of toxicity (Maier et al 2015 ). In addition, amounts of residual solvent in electrospun meshes would be lower than in most ethanol-based products in both of the studies described above.…”