Publications : 2022

Kozal JS, Vincent MJ, Gloekler LE, De Gandiaga EJ, Massarsky A, Zisook RE, Binczewski NR, et al. Risk assessment of organic impurities detected in hand sanitizers marketed to children during the COVID-19 pandemic. Poster presentation P530 at the Society of Toxicology (SOT) Annual Meeting & ToxExpo, San Diego, CA. Toxicologist 186(S1):150. Abstract 3341. March 2022.


Due to increased demand for hand sanitizer during the COVID-19 pandemic, the US Food and Drug Administration (FDA) established temporary guidance for the preparation of alcohol based hand sanitizer, including interim limits for organic impurities in the source alcohol. FDA has recommended against the use of certain hand sanitizers due to exceedances of these limits. However, it is unclear whether these limits are heath-based and protective of sensitive populations, such as children. The purpose of the current research was to determine if children are at an increased risk of adverse health effects following potential exposure to hand sanitizer via different user scenarios, including intended dermal application or incidental ingestion. A recent market survey of hand sanitizers marketed to children reported detection of various organic impurities (i.e. acetaldehyde, methanol, 1-propanol, ethyl acetate, isobutanol, benzene, and acetal) in certain products. Levels of benzene, acetaldehyde, and acetal exceeded the FDA interim limits in a subset of these products. Using the worst-case impurity levels reported from all products, we conducted a screening level risk assessment to identify the potential risk of systemic health effects in different age groups of children following different exposure pathways and durations. Specifically, we used health protective assumptions to estimate systemic exposure doses (SEDs) that may result from subacute and subchronic repeated dermal use, as well as acute incidental ingestion (hand-tomouth, lick, and mouthful). We identified health-based guidance values established by government and regulatory bodies and appropriate no observed adverse effect levels (NOAELs) from in vivo studies to characterize the risk associated with use of these hand sanitizers by calculating margins of safety using the SEDs. Preliminary results suggest no risk of systemic health effects to children from use of these hand sanitizers under the recommended or anticipated use conditions evaluated. More refined risk assessments are underway.