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

Université de Montréal

Status: Unknown

Conditions: Heat

Treatments: Other: Heat stress (25) + DCM; Other: Heat Stress (21) +TOL; Other: Heat stress (25) + TOL; Other: Heat stress (21) + TOL; Other: Heat stress (21) + DCM; Other: Heat stress (30) + TOL (dermal); Other: Heat stress (30) + ACE; Other: Heat stress (21); Other: Heat stress (25); Other: Heat stress (30); Other: Heat stress (21) + ACE; Other: Heat stress (25) + ACE; Other: Heat stress (25) + TOL (dermal); Other: Heat stress (30) + DCM; Other: Heat stress (21) + TOL (dermal)

Study type: Interventional

Funder types: Other

Identifiers

NCT02659410

2013-0012

14-140-CERES-P

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Heat stress

Experimental group

Description:

4h exposure to heat stress alone or in combination with different solvents. Solvent concentrations are equal to their TLV. Heat conditions are 21, 25 and 30°C (WBGT). Inhalation exposure for all solvents and demal exposure for toluene.

Treatment:

Other: Heat stress (25) + DCM

Other: Heat stress (30) + DCM

Other: Heat stress (25) + TOL

Other: Heat stress (21) + DCM

Other: Heat Stress (21) +TOL

Other: Heat stress (30) + TOL (dermal)

Other: Heat stress (30) + ACE

Other: Heat stress (21) + TOL

Other: Heat stress (30)

Other: Heat stress (25) + ACE

Other: Heat stress (25) + TOL (dermal)

Other: Heat stress (21)

Other: Heat stress (25)

Other: Heat stress (21) + TOL (dermal)

Other: Heat stress (21) + ACE