Toxicological evaluation of aerosols of a tobacco extract formulation and nicotine formulation in acute and short-term inhalation studies. (March 2014)

• Record Type: Journal Article
• Authors: Werley, Michael S.; Jerome, Ann M.; Oldham, Michael J.
• Is Part Of: Inhalation toxicology. Volume 26:Number 4(2014)
• Page Start: 207
• Page End: 221
• Publication Date: 2014-03
• Subjects: Pulmonary toxicology -- Animal models -- Periodicals; Pulmonary toxicology -- Periodicals; Air -- Pollution -- Health aspects -- Periodicals; 616.200471
• DOI: 10.3109/08958378.2013.878005
• Languages: English
• ISSNs: 0895-8378

Abstract

<abstract> <title>Abstract</title> <p>A formulation of tobacco extract containing 4% nicotine (TE) and similar nicotine formulation containing vehicle and 4% nicotine (NF) were evaluated using animal inhalation assays. Two 4-h inhalation exposures at 1 and 2 mg/L aerosol exposure concentrations, respectively, of the tobacco extract with 4% nicotine formulation showed that the LC<sub>50</sub> was greater than 2 mg/L, the maximum concentration tested. All inhalation exposures were conducted using the capillary aerosol generator (CAG). Increasing aerosol TPM concentrations (0, 10, 50, 200, 1000 mg/m<sup>3</sup> TE and 0, 50, 200, 500, 1000 mg/m<sup>3</sup> NF) were generated via the CAG and used to expose groups of male and female rats for 4-h per day for 14 days. In life monitors for potential effects included clinical observations, weekly body weights and food consumption. <italic>Post mortem</italic> evaluations included gross tissue findings, hematology, clinical chemistry, serum plasma and nicotine levels, absolute and normalized organ and tissue weights, and histopathology of target organs. Treatment-related changes were observed in body weights, hematology, clinical chemistry, organ weights and histopathological findings for TE at the 200 and 1000 mg/m<sup>3</sup> exposure levels, and in the 500 and 1000 mg/m<sup>3</sup> exposure groups for NF. Under the conditions of these studies, the no-observed-adverse-effect level in the rat was approximately 50 mg/m<sup>3</sup> for the TE aerosol-exposed groups, and approximately 200 mg/m<sup>3</sup> in the NF aerosol-exposed groups.</p> </abstract>