Evaluation of inhalation and dermal exposure to VOCs and SVOCs from commercial nebulizers in the pediatric population.

Abstract

Objective: Nebulizers are medical devices that convert liquid solutions, such as saline or medication, into aerosols for direct airway delivery. Their effectiveness relies on interfaces, typically made from polymeric materials containing additives to enhance functionality and durability. This study aimed to characterize emissions of volatile organic compounds (VOCs) and semi-volatile organic compounds (SVOCs) from different components of five nebulizers, considering two exposure routes: inhalation and dermal contact.

Materials and methods: Five nebulizers were assessed by analyzing emissions from individual components and from complete system configurations. VOC and SVOC emissions were quantified and short-term exposure (20 minutes) was assessed for infants and children. Estimated exposure levels were compared with toxicological reference values, including inhalation Derived No-Effect Levels (DNELs), to evaluate potential health risks via inhalation and dermal contact.

Results: All tested components emitted VOCs, with the highest concentrations detected in masks and whole-system configurations. Some identified compounds, including toluene, styrene, siloxane D4, and 2-ethylhexanoic acid, are suspected or recognized reproductive toxicants. Although measured levels were very low, inhalation represents a potential exposure route warranting a precautionary approach. Phenol, a suspected mutagen, reached concentrations up to 65.9 μg/m³, corresponding to 11.7% of the inhalation DNEL for a 20-minute exposure in infants and children. Dermal exposure levels were very low compared with toxicological reference values. Nevertheless, compounds such as benzyl alcohol and 2-ethylhexyl acrylate, both recognized as EU-classified skin sensitizers, were detected. Cyclic siloxanes D5, D6, and D7 were also detected, with D6 showing the highest dermal intake. As these siloxanes are classified as Persistent, Bioaccumulative and Toxic (PBT) in the EU, long-term effects from bioaccumulation and environmental persistence should be considered.

Discussion and conclusions: Although measured VOC and SVOC concentrations were low and below established toxicological thresholds, these findings underscore the need for preventive measures, particularly for sensitive populations such as infants and children. Inhalation appears to be the most relevant exposure pathway during use, while dermal exposure, though minimal, may contribute to sensitization risks. The presence of PBT-classified siloxanes further emphasizes the need to consider long-term human health and environmental implications. Overall, these findings support the implementation of preventive strategies and continued monitoring of material emissions in medical devices intended for vulnerable users.