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EC number: 203-489-0
CAS number: 107-41-5
The oral toxicity of hexylene glycol has been assessed in a 90-day repeated dose study in rats (Fabreguettes, 1999). This GLP study was conducted according to OECD test guideline 408 (1981). Hexylene glycol was administered by oral gavage to groups of male and female Sprague Dawley rats daily for 13 weeks at dose levels of 0 (water vehicle), 50, 150, or 450 mg/kg body weight/day. Main study animals were killed the day after the last dose and subjected to full necropsy examinations that included gross pathology, clinical pathology, and tissue harvest for histopathology. Subsets of animals from the vehicle and high-dose groups were allowed to recover for 4 weeks following the last dose before being killed to assess the reversibility of any effects noted in the main study animals. All animals also were subjected to ophthalmology and neurological examinations.
Hexylene glycol was well tolerated at all dose levels. No effects of treatment were observed on mortality, clinical signs, body weight, food or water consumption, food efficiency, ophthalmology, or neurobehaviour. Minor and/or reversible effects associated with treatment were observed on haematology (increased fibrinogen in mid- and high-dose males and in high-dose females, considered secondary to inflammatory lesions in the stomach and forestomach), clinical chemistry (increased cholesterol in high-dose males and females and decreased glucose in mid- and high-dose animals of both sexes, considered related to increased demand in liver function noted histologically, with evidence of reversibility), urinalysis (lower pH and higher specific gravity in high-dose males, considered secondary to male rat-specific excretion of alpha-2-µ-globulin, with evidence of reversibility), and organ weights (higher liver weight in high-dose males and females and higher kidney weight in high-dose males, with evidence of reversibility). Macroscopic lesions were noted on kidneys of high-dose males at the end of the treatment period, with evidence of reversibility. Microscopic findings in the mid- and high-dose groups included hepatocellular hypertrophy in both sexes (considered a response to an increased demand in liver function), kidney changes in males (acidophilic globules in tubular epithelium, tubular basophilia, and peritubular fibrosis; all considered related to alpha-2-µ-globulin), and local irritating effects in the stomach and forestomach of both sexes (but more prominent in males). All of these microscopic effects showed evidence of reversibility. Based on these findings a NOEL of 50 mg/kg body weight/day and a NOAEL of 450 mg/kg body weight/day (the highest dose tested) were derived (Fabreguettes, 1999).
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