Subchronic toxicity evaluation of tridecyl acetate in rats

Tridecyl acetate was administered to male and female Sprague-Dawley rats by oral gavage, 5 days per week for 13 weeks (90 days). Treated rats received daily doses of 0.1, 0.5, or 1.0 g/kg/day and control rats received distilled water at a dose of 1.0 g/kg/day. After 45 days an interim termination was made to evaluate potential hematologic or hepatic effects of tridecyl acetate. Blood samples were collected for routine hematology and serum chemistry determinations and liver tissue was obtained for histological examination. After 90 days all animals were necropsied. Blood samples were obtained and selected organs were weighed and prepared for histological examination. Treatment-related effects observed in the mid and high dose groups consisted of (1) increased liver weights and/or liver/body weight ratios in both sexes at the interim and 13 week termination, (2) increased kidney weights and/or kidney/body weight ratios in both sexes at the terminal necropsy, (3) histopathologic evidence of hydrocarbon nephropathy in males, and (4) a slight decrease in serum glucose levels in male rats at both the interim and terminal necropsies. The increases in liver weight are believed to be a normal physiological response to a chemical challenge. The nephropathy produced by tridecyl acetate is characteristic of that produced by a diverse group of hydrocarbons and, to date, appears to be limited to male rats. The low dose in this study was a no observed effect level. These results are indicative of an overall low degree of systemic toxicity following subchronic oral administration of tridecyl acetate at doses up to 1 g/kg body weight.