Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 24, 2023
Date Accepted: Jul 26, 2023
A novel protocol for repeated human exposure to semi-volatile organic compounds by inhalation
ABSTRACT
Background:
Semi-volatile organic compounds (SVOCs) comprise several different chemical families used mainly as additives in many everyday products. SVOCs can be released into the air as aerosols and deposit on particulate matter during use by dispersion, evaporation, or abrasion. Phthalates are SVOCs of growing concern due to their endocrine disrupting effects. Human data on the absorption, distribution, metabolism, and excretion (ADME) of these compounds upon inhalation are almost non-existent.
Objective:
The goal of this study is to develop a method for repeated inhalation exposures to SVOCs to characterize their ADME in humans.
Methods:
Diethylhexyl phthalate (DEHP), a major indoor air pollutant, is used as a model SVOC in this novel protocol. The Swiss official Commission on Ethics in Human Research, Canton de Vaud, approved the study on 14 October 2020 (project-ID 2020-01095). Participants (n = 10) will be repeatedly exposed (two short daily exposures over four days) to isotope-labeled DEHP (DEHP-d4) to distinguish administered from background exposures. DEHP-d4 aerosols will be generated with a small portable aerosol-generating device. Participants will inhale DEHP-d4-containing aerosols themselves with this device at home. Air concentrations of the airborne phthalates will be less than or equal to its occupational exposure limit (OEL). DEHP-d4 and its metabolites will be quantified in urine and blood before, during, and after the exposure.
Results:
Our developed device can generate DEHP-d4 aerosols with diameters of 2.5 μm or smaller and a mean DEHP-d4 mass of 1.4 ± 0.2 μg/puff (n=6). As of May 2023, we have enrolled five participants.
Conclusions:
The portable device can be used to generate phtalate aerosols for repeated exposure in human studies. Clinical Trial: Not applicable
Citation
Per the author's request the PDF is not available.
Copyright
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