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Three month oral toxicity study of etodolac in rats followed by one month recovery test



Three month oral toxicity study of etodolac in rats followed by one month recovery test



Oyo Yakuri 40(5): 491-513



A subacute toxicity test was made of etodolac, a novel nonsteroidal anti-inflammatory drug. Three groups of male and female rats were given etodolac orally for 3 months at doses of 4 (low-dose), 10 (intermediate-dose) and 25 (high-dose) mg/kg/day. A fourth group served as controls. Randomly selected male and female rats of the control group and the intermediate-dose group were placed on withdrawal for one additional month in order to study the reversibility of the phenomena observed after the period of drug administration. Results showed: 1. In the high-dose group, dark brown feces appeared and the body weight gain decreased: moreover, 5 out of 10 males and 2 out of 10 females were found dead. 2. Ophthalmological examination and urinalysis failed to show any drug-related abnormalities. 3. Hematological examination showed anemia, neutrophilia, reticulocytosis and thrombocytosis in the high-dose groups. 4. Serum biochemical examination revealed decreased levels of glucose and total protein and increased levels of triglyceride and K+ in the high-dose group. 5. Pathological examination revealed gastro-intestinal ulcers in the intermediate- and high-dose groups. 6. After the recovery period, the above abnormalities were no longer present. These results show that toxicologically the non-effective dose level of etodolac is 4 mg/kg/day when the drug is given orally to rats for 3 months.

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