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5-Day Gavage Study of Propylene glycol phenyl ether (PPH; CASRN 770-35-4) in Male Harlan Sprague Dawley Rats

ABSTRACT: The goal of this study was to characterize the potential toxicity and genomic benchmark dose of propylene glycol phenyl etherl in liver and kidney of male Harlan Sprague Dawley rats using a 5 day dose-response toxicogenomics study design. The 5 day study is used to quickly identify the dose levels where changes in molecular pathways occur. These dose level where pathway level effects begin to occur have been shown to provide a close approximation of a no effect dose level from more resource intensive guideline toxicological assessments.

ORGANISM(S): Rattus norvegicus

PROVIDER: GSE75656 | GEO | 2015/12/31

SECONDARY ACCESSION(S): PRJNA304987

REPOSITORIES: GEO

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Project description:Propylene glycol (PG) is a common carrier in e-vapor formulations and its properties have been extensively studied. In this 13-week subchronic nose-only inhalation study, Sprague Dawley rats were exposed to filtered air (sham control group), propylene glycol/water (PG/W; 90:10) or a propylene glycol/vegetable glycerin/water (PG/VG/W; 50:40:10) reference. The reference containing vegetable glycerin group was added at the high dose to observe any changes that might be associated with a carrier more in line with e-vapor products. The objectives of this study were to increase the PG exposure above the concentrations tested by Suber et al. and use a systems toxicology analysis of lung tissue to further our understanding of molecular events after PG exposures (Suber et al. 1989). Macroscopic examinations at necropsy as well as terminal organ weights revealed no observations that were associated with exposure to PG/W or reference. Food consumption and body weights were unaffected by PG/W or reference when compared to the sham. No exposure related alterations were observed in serum chemistry, hematology, coagulation, urinalysis or BALF cytology and clinical chemistry. Although clinical observations of dried red material around the nose in the high dose PG/W group were reported, histopathology of the nasal cavity showed no nasal hemorrhaging. There were non-adverse PG/W and reference related findings of minimal mucus cell hyperplasia noted in nasal cavity section II. These findings were considered non-adverse as they were also found to a lesser extent in the filtered air controls. No other exposure-related findings were noted in the primary or recovery necropsies. A systems toxicology analysis on lung tissue showed no statistically-significant differentially expressed transcripts or proteins compared to the sham group. The endpoints measured from the PG/W high dose group did not differ significantly from those in the more common carrier PG/VG/W. Accordingly, the highest PG exposure (5 mg/L, 6 hrs/day) was regarded as the no observed adverse effect concentration (NOAEC), corresponding to a PG delivered dose of 1,152 mg/kg/day in rats.

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5-Day Gavage Study of Propylene glycol phenyl ether (PPH; CASRN 770-35-4) in Male Harlan Sprague Dawley Rats

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