Subchronic inhalation of a novel electronic nicotine delivery system formulation and its corresponding base formulation

Subchronic inhalation of a novel electronic nicotine delivery system formulation and its corresponding base formulation

Fresh Menthol 3% Nicotine (FM3) is a novel JUUL e-liquid formulation. Its potential toxicity and that of the corresponding base formulation relative to a filtered air (FA) control was studied in a subchronic inhalation study conducted in general accordance with OECD 413. Aerosols generated with an i...

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Bibliographic Details
Published in:Human & experimental toxicology Vol. 43; p. 9603271241248631
Main Authors: Lalonde, Guy, Tsolakos, Nikos, Moir-Savitz, Tessa R, Easley, Alex M, Gaworski, Charles L, Oldham, Michael J
Format: Journal Article
Language:English
Published: England 01-01-2024
Subjects:
Administration, Inhalation
Aerosols
Animals
Electronic Nicotine Delivery Systems
Female
Inhalation Exposure
Male
Menthol - administration & dosage
Menthol - toxicity
Nicotine - administration & dosage
Nicotine - toxicity
Rats
Rats, Sprague-Dawley
Toxicity Tests, Subchronic
OECD 413
electronic nicotine delivery systems
rats
subchronic
Inhalation toxicology
base formulation
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Summary:Fresh Menthol 3% Nicotine (FM3) is a novel JUUL e-liquid formulation. Its potential toxicity and that of the corresponding base formulation relative to a filtered air (FA) control was studied in a subchronic inhalation study conducted in general accordance with OECD 413. Aerosols generated with an intense puffing regime were administered to rats in a nose-only fashion at 1400 µg aerosol collected mass/L on a 6 hour/day basis for 90 days with a 42-day recovery. Exposure atmospheres met target criteria. Systemic exposure was confirmed by plasma measurement of nicotine. No test article-related mortality, clinical signs (other than reversible lower body weight gains in males), clinical pathology or gross findings were noted during this study. No microscopic lesions related to base formulation exposure were identified. Minimal microscopic lesions were observed in the FM3 6-hour exposure group. Microscopic lesions observed in the FM3 6-hour exposure group comprised only minimal laryngeal squamous metaplasia in one male and one female animal. No microscopic lesions related to FM3 exposure remained after the recovery period. Exposure atmosphere characterization indicated that conditions were achieved to permit thorough assessment of test articles and results indicate a low order of toxicity for the FM3 Electronic nicotine delivery systems (ENDS) formulation and its base formulation.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
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content type line 23
ISSN:0960-3271
1477-0903
DOI:10.1177/09603271241248631