Toxicological studies on tienilic acid in rats

The subacute oral toxicity of tienilic acid in male and female Sprague--Dawley rats has been studied. Animals were given tienilic acid 0, 30, 120 and 480 mg/kg body weight as a 3% gum arabic suspension for 28 days. At 30 mg tienilic acid blood pressure and serum uric acid decreased. At the two higher dose-levels a slight decrease in hemoglobin and an increase in S-GPT was noticed and there was a significant increase in the liver weight and serum magnesium concentration of male rats, while the liver weight of female rats increased only slightly. On microscopic examination, unicellular necrosis of small groups of liver cells was noted, together with focal round-cell infiltration and some stasis of the two higher dose-levels in some animals. Tienilic acid had no noticeable effects on other organs or parameters.