Document Type
Article
Department/Program
Virginia Institute of Marine Science
Publication Date
2022
Journal
International Journal of Environmental Research and Public Health
Volume
19
Issue
21
First Page
14424
Abstract
Hand sanitizer use in the United States (U.S.) increased after the SARS-CoV-2 outbreak. The U.S. Food and Drug Administration (FDA) released temporary manufacturer guidance, changing impurity level limits for alcohol-based hand sanitizers (ABHSs). Since the guidance took effect, the FDA has recommended against using these hand sanitizers due to concerns over safety, efficacy, and/or risk of incidental ingestion. To address current gaps in exposure characterization, this study describes a survey of ABHSs marketed to children available in the U.S., as defined by several inclusion criteria. A subset of ABHSs (n = 31) were evaluated for ethanol and organic impurities using a modified FDA method. Products with detectable impurity levels were compared to the FDA’s established interim limits. Seven children’s products had impurity levels exceeding the FDA’s recommended interim limits, including benzene (up to 9.14 ppm), acetaldehyde (up to 134.12 ppm), and acetal (up to 75.60 ppm). The total measured alcohol content ranged from 52% to 98% in all hand sanitizers tested, ranging from 39% below, and up to 31% above, the labeled concentration. Future studies should confirm impurity contamination sources. A risk assessment could determine whether dermal application or incidental ingestion of impurity-containing hand sanitizers pose any consumer risk.
DOI
DOI: 10.3390/ijerph192114424
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Recommended Citation
Gloekler, L.E.; de Gandiaga, E.J.; Binczewski, N.R.; (...); La Guardia, Mark J.; and et al, Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic (2022). International Journal of Environmental Research and Public Health, 19(21), 14424.
DOI: 10.3390/ijerph192114424
