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

Author

Listed:
  • 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)

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.

Suggested Citation

  • 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 & Shannon Ga, 2022. "Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic," IJERPH, MDPI, vol. 19(21), pages 1-18, November.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:21:p:14424-:d:962728
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    References listed on IDEAS

    as
    1. Timothy J. Tse & Fina B. Nelson & Martin J. T. Reaney, 2021. "Analyses of Commercially Available Alcohol-Based Hand Rubs Formulated with Compliant and Non-Compliant Ethanol," IJERPH, MDPI, vol. 18(7), pages 1-12, April.
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