PMID- 37831504
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231030
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 12
DP  - 2023 Oct 13
TI  - Repeated Human Exposure to Semivolatile Organic Compounds by Inhalation: Novel 
      Protocol for a Nonrandomized Study.
PG  - e51020
LID - 10.2196/51020 [doi]
LID - e51020
AB  - 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 mum or smaller and a 
      mean DEHP-d4 mass of 1.4 (SD 0.2) mug 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. INTERNATIONAL 
      REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51020.
CI  - (c)Elena Reale, Nancy B Hopf, Florian Breider, Dominique Grandjean, Catherine 
      Pirard, Corinne Charlier, Holger M Koch, Aurelie Berthet, Guillaume Suarez, 
      Myriam Borgatta. Originally published in JMIR Research Protocols 
      (https://www.researchprotocols.org), 13.10.2023.
FAU - Reale, Elena
AU  - Reale E
AUID- ORCID: 0000-0002-0853-0693
AD  - Department of Occupational Health, Center for Primary Care and Public Health 
      (Unisante), University of Lausanne, Lausanne, Switzerland.
FAU - Hopf, Nancy B
AU  - Hopf NB
AUID- ORCID: 0000-0002-4490-6109
AD  - Department of Occupational Health, Center for Primary Care and Public Health 
      (Unisante), University of Lausanne, Lausanne, Switzerland.
AD  - Swiss Centre for Applied Human Toxicology, Basel, Switzerland.
FAU - Breider, Florian
AU  - Breider F
AUID- ORCID: 0000-0002-5698-0314
AD  - Central Environmental Laboratory, Ecole Polytechnique Federale de Lausanne, 
      Lausanne, Switzerland.
FAU - Grandjean, Dominique
AU  - Grandjean D
AUID- ORCID: 0000-0002-5695-815X
AD  - Central Environmental Laboratory, Ecole Polytechnique Federale de Lausanne, 
      Lausanne, Switzerland.
FAU - Pirard, Catherine
AU  - Pirard C
AUID- ORCID: 0000-0003-3109-3775
AD  - Center for Interdisciplinary Research on Medicines, University of Liege, Liege, 
      Belgium.
AD  - Laboratory of Clinical, Forensic and Environmental Toxicology, University 
      Hospital of Liege, Liege, Belgium.
FAU - Charlier, Corinne
AU  - Charlier C
AUID- ORCID: 0000-0002-5414-2544
AD  - Center for Interdisciplinary Research on Medicines, University of Liege, Liege, 
      Belgium.
AD  - Laboratory of Clinical, Forensic and Environmental Toxicology, University 
      Hospital of Liege, Liege, Belgium.
FAU - Koch, Holger M
AU  - Koch HM
AUID- ORCID: 0000-0002-8328-2837
AD  - Institute for Prevention and Occupational Medicine of the German Social Accident 
      Insurance, Institute of the Ruhr-University Bochum, Bochum, Germany.
FAU - Berthet, Aurelie
AU  - Berthet A
AUID- ORCID: 0000-0002-8625-5156
AD  - Department of Occupational Health, Center for Primary Care and Public Health 
      (Unisante), University of Lausanne, Lausanne, Switzerland.
FAU - Suarez, Guillaume
AU  - Suarez G
AUID- ORCID: 0000-0002-5914-1559
AD  - Department of Occupational Health, Center for Primary Care and Public Health 
      (Unisante), University of Lausanne, Lausanne, Switzerland.
FAU - Borgatta, Myriam
AU  - Borgatta M
AUID- ORCID: 0000-0002-6326-0614
AD  - Department of Occupational Health, Center for Primary Care and Public Health 
      (Unisante), University of Lausanne, Lausanne, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20231013
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC10612011
OTO - NOTNLM
OT  - DEHP
OT  - SVOCs
OT  - diethylhexyl phthalate
OT  - healthy participants
OT  - inhalation exposure
OT  - phthalates
OT  - portable aerosol-generating device
OT  - protocol
OT  - semi-volatile organic compounds
OT  - toxicokinetics study
OT  - toxicology
COIS- Conflicts of Interest: None declared.
EDAT- 2023/10/13 12:44
MHDA- 2023/10/13 12:45
PMCR- 2023/10/13
CRDT- 2023/10/13 11:54
PHST- 2023/07/24 00:00 [received]
PHST- 2023/07/26 00:00 [accepted]
PHST- 2023/10/13 12:45 [medline]
PHST- 2023/10/13 12:44 [pubmed]
PHST- 2023/10/13 11:54 [entrez]
PHST- 2023/10/13 00:00 [pmc-release]
AID - v12i1e51020 [pii]
AID - 10.2196/51020 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2023 Oct 13;12:e51020. doi: 10.2196/51020.