Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic

Lauren E. Gloekler (), Elise J. de Gandiaga, Natalie R. Binczewski, Katie G. Steimel, Andrey Massarsky, Jordan Kozal, Melissa Vincent, Rachel Zisook, Mark J. LaGuardia, Scott Dotson and Shannon Gaffney
Additional contact information
Lauren E. Gloekler: Stantec (ChemRisk), Aliso Viejo, CA 92656, USA
Elise J. de Gandiaga: Stantec (ChemRisk), Aliso Viejo, CA 92656, USA
Natalie R. Binczewski: Stantec (ChemRisk), Aliso Viejo, CA 92656, USA
Katie G. Steimel: Stantec (ChemRisk), Aliso Viejo, CA 92656, USA
Andrey Massarsky: Stantec (ChemRisk), Aliso Viejo, CA 92656, USA
Jordan Kozal: Stantec (ChemRisk), San Francisco, CA 94104, USA
Melissa Vincent: Stantec (ChemRisk), Cincinnati, OH 45242, USA
Rachel Zisook: Stantec (ChemRisk), San Francisco, CA 94104, USA
Mark J. LaGuardia: Virginia Institute of Marine Science, William & Mary, Gloucester Point, VA 23062, USA
Scott Dotson: Insight Exposure and Risk Sciences Group, Cincinnati, OH 45249, USA
Shannon Gaffney: Stantec (ChemRisk), San Francisco, CA 94104, USA

IJERPH, 2022, vol. 19, issue 21, 1-18

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.

Keywords: hand sanitizer; consumer products; children; impurities; ethanol; COVID-19 (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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