Impact of Thermal Stress on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

Studying the Impact of Thermal Stress (Heat) Representative of Occupational Settings on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02659410

Enrollment

Registered

2016-01-20

Start date

2015-11-30

Completion date

2018-06-30

Last updated

2016-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heat

Keywords

Physiologically based pharmacokinetic modeling, Organic solvents

Brief summary

In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds. Exposure to heat induces physiological responses that help maintaining a stable body temperature. Those changes can affect organ functions implicated in absorption and metabolism. According to literature, those changes could lead to increased concentrations of chemical compounds in the body and their toxicity. Therefore, the aim of this study is to evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress conditions in volunteers exposed in a inhalation chamber. Results will then be used to develop PBPK models that will allow to predict organic solvent kinetics when coexposed with heat.

Interventions

OTHERHeat stress (21)

4h exposure to heat (WBGT of 21°C), no solvent

OTHERHeat stress (25)

4h exposure to heat (WBGT of 25°C), no solvent

OTHERHeat stress (30)

4h exposure to heat (WBGT of 30°C), no solvent

OTHERHeat Stress (21) +TOL

4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV)

OTHERHeat stress (25) + TOL

4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV)

OTHERHeat stress (21) + TOL

4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV)

OTHERHeat stress (21) + ACE

4h exposure to heat (WBGT of 21°C) + Acetone (concentration = TLV)

OTHERHeat stress (25) + ACE

4h exposure to heat (WBGT of 25°C) + Acetone (concentration = TLV)

OTHERHeat stress (30) + ACE

4h exposure to heat (WBGT of 30°C) + Acetone (concentration = TLV)

OTHERHeat stress (21) + DCM

4h exposure to heat (WBGT of 21°C) + Dichloromethane (concentration = TLV)

OTHERHeat stress (25) + DCM

4h exposure to heat (WBGT of 25°C) + Dichloromethane (concentration = TLV)

OTHERHeat stress (30) + DCM

4h exposure to heat (WBGT of 30°C) + Dichloromethane (concentration = TLV)

OTHERHeat stress (21) + TOL (dermal)

4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.

OTHERHeat stress (25) + TOL (dermal)

4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.

OTHERHeat stress (30) + TOL (dermal)

4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Body mass index between 18,5 et 25 kg/m3

Exclusion criteria

* Smoking * Respiratory, cardiovascular and neurological problems * History of exposure to solvents * Chronic medication * Abusive and/or chronic alcohol consumption * Alcohol consumption 24h before or 18h following exposure

Design outcomes

Primary

Measure	Time frame	Description
Solvent in exhaled air	6hour	Solvents concentrations will be measured in exhaled air samples collected at different times (t=0, 1.5, 3, 4.5 and 6hour).
Tidal volume	4hour	Tidal volume will be monitored continuously for 4hour with a respirometer
Solvent in blood	4,5hour	Solvents concentrations will be measured in blood samples collected at different times (t=0, 2, 4 and 4.5hour).
Solvent or metabolite in urine	18hour	Solvent or metabolite concentrations (o-cresol for toluene exposures) will be measured for urine samples collected at different times (t=0, 4, 10 and 18hour).
Respiratory rate	4hour	Respiratory rate will be monitored continuously for 4hour with a respirometer
Cardiac frequency	4hour	Cardiac frequency will be monitored continuously for 4hour with a respirometer
Minute ventilation	4hour	Minute ventilation will be monitored continuously for 4hour with a respirometer

Secondary

Measure	Time frame	Description
Carbonic dioxide production	4hour	carbonic dioxide production will be monitored continuously for 4hour with a respirometer
Body temperature	4hour	Body temperature is monitored continuously by telemetry
Oxygen consumption	4hour	oxygen consumption will be monitored continuously for 4hour with a respirometer

Countries

Canada

Contacts

Primary ContactSami Haddad, Ph.D

sami.haddad@umontreal.ca514-343-6111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026