Publications : 2022

Han AA, Buerger AN, Allen H, Vincent M, Thornton AA, Unice K, Maier A. Assessment of ethanol exposure in nursing infants from maternal hand sanitizer use and potential for developmental toxicity. Poster presentation P514 at the Society of Toxicology (SOT) Annual Meeting & ToxExpo, San Diego, CA. Toxicologist 186(S1):146. Abstract 3325. March 2022.


Ingestion of ethanol during pregnancy is known to have detrimental effects on the fetus. Although the potential developmental effects of maternal ethanol intake during lactation are less well characterized, public health guidelines recommend either avoidance of alcohol or, if alcohol is consumed, to allow for 1-2 hours to pass before nursing. An impending proposal by the Greek Competent Authority to classify all ethanol exposures as potentially harmful to breast-fed children warrants an investigation of the potential adverse neurodevelopmental effects from low-dose ethanol exposure during lactation. The results of our literature search demonstrated that there are no studies that have examined neurodevelopmental outcomes from lactational exposure to ethanol resulting from maternal use of topical products that contain ethanol, such as alcohol-based hand sanitizers (ABHS). The published epidemiological literature of lactational ethanol exposures from maternal alcohol consumption is limited in design, provides equivocal evidence of neurological effects in offspring, and is insufficient to characterize a dose-response relationship for developmental effects. Toxicological studies that observed neurodevelopmental effects in pups from ethanol exposure via lactation did so at exceedingly high doses that also caused maternal toxicity. In this investigation, physiologically based pharmacokinetic (PBPK) modeling was performed to predict blood ethanol concentrations (BECs) of breastfeeding mothers following typical-to-intense ABHS use, and the predicted BECs were compared to toxicological and public health benchmarks to quantify the risk for developmental outcomes. Margins of 2.2 to 1,000 exist between BECs associated with typical-to-intense ABHS use compared to BECs associated with neurotoxicity adverse effect levels in the toxicological literature and BECs associated with suggested oral ethanol intake for lactating mothers per public health guidelines. These findings suggest that neurodevelopmental effects are not likely to occur in offspring due to ABHS use by breastfeeding mothers, even when ABHSs are used at intense frequencies.