BACKGROUND
Semivolatile 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 nonexistent.
OBJECTIVE
The goal of this study is to develop a method for repeated inhalation exposures to SVOCs to characterize their ADME in humans.
METHODS
We will use diethylhexyl phthalate (DEHP), a major indoor air pollutant, as a model SVOC in this novel protocol. The Swiss official Commission on Ethics in Human Research, Canton de Vaud, approved the study on October 14, 2020 (project-ID 2020-01095). Participants (n=10) will be repeatedly exposed (2 short daily exposures over 4 days) to isotope-labeled DEHP (DEHP-d4) to distinguish administered exposures 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 their occupational exposure limit (OEL). DEHP-d4 and its metabolites will be quantified in urine and blood before, during, and after 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 (SD 0.2) μg per puff (n=6). As of May 2023, we have enrolled 5 participants.
CONCLUSIONS
The portable device can be used to generate phthalate aerosols for repeated exposure in human studies.
CLINICALTRIAL
INTERNATIONAL REGISTERED REPORT
DERR1-10.2196/51020