SIX MONTH ORAL CHRONIC TOXICITY STUDY OF T-3262 IN BEAGLES

• Published in: CHEMOTHERAPY Vol. 36; no. Supplement9-Base; pp. 250 - 293
• Main Authors: NAKAGAWA, SHIGEHITO, UEHARA, KYO, NAGAI, AKIO, NAGASAWA, MINEKO, YOSHIDA, KAZUHARU, YONEDA, TOYOAKI
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 30-12-1988
• ISSN: 0009-3165; 1884-5894
• DOI: 10.11250/chemotherapy1953.36.Supplement9-Base_250

We carrid out a chronic toxicity study of T-3262, a new synthetic antibacterial agent, in 40 beagles (20 males and 20 females) by oral administration. The dogs were divided into three groups at dose levels of 400, 100 and 25mg/kg/day and a control group. The following results were obtained. 1) Symptomatically, test material was observed in the feces of all dogs given 400 mg/kg/day throughoat the study. The Same phenomenon was sporadically recognized in a few dogs recieving 100mg/kg/day, but not in the 25mg/kg/day group. Two of the 12 dogs in the 400mg/kg/day group showed a slight decrease of body weight. There were no significant changes in food intake, electrocardiogram and ophthalmic examination. 2) In urinalysis, crystals which seemed to be test material in the urinary sediment, were observed in 3 of 12 dogs, 4 of 8 dogs and 2 of 8 dogs at dose levels of 400mg/kg, 100mg/kg and 25mg/kg, respectively. 3) No T-3262-related abnormality was observed in hematological examination. 4) A slight decrease in total protein and slight increase in the A/G ratio were found in all T-3262-treated groups from 2 months of administration, but these changes showed no clear dose-dependent relationship. A slight decrease in total protein, total cholesterol, triglycerides and phospholipids was found in one of the two dogs which showed slight body-weight loss. 5) No remarkable changes were seen in gross anatomical, histological and electronmicroscopic examinations. 6) Based upon the above results, the maximum no-effect dose of T-3262 was estimated to be 100mg/kg.