The Japanese Journal of Antibiotics

A thirteen-week intravenous repeated dose toxicity study of T-3762, parenteral quinolone antimicrobial agent, and four-week recovery test was carried out in male and female cynomolgus monkeys at dosages of 26, 52 and 104 mg/kg. The following results were obtained.
1) There was no death of animals during administration period at any dose levels. In general signs, there was no abnormality at any dose levels.
2) In appetite, body weights and ophthalmological examination, there was no abnormality attributable to the treatment.
3) In urinalysis, hematological examination and biochemical examination, there was no abnormality attributable to the treatment.
4) In organ weights, macroscopic findings and histopathological findings, there was no abnormality attributable to the treatment.
5) From these results in this study, no-toxic dose level of T-3762 for cynomolgus monkeys is considered over 104 mg/kg.

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A teratogenicity study of T-3762, an injectable new quinolone antibacterial agent, was conducted in Sprague-Dawley rats to determine the effects on dams and next generations. T-3762 was administered intravenously to pregnant rats at the dose levels of 26, 78 and 156 mg/kg/day from day 7 to day 17 of gestation, during the organogenesis.
1. In the dams, there were no effects on general condition, food intake, water intake and body weight in the T-3762 treated groups. There were no abnormal findings on the autopsy at the end of gestation and lactation periods in the T-3762 treated groups.
2. In the fetuses, there were no effects on the number of dead and live fetuses, sex ratio and body weight in the T-3762 treated groups. No external, visceral and skeletal abnormalities attributed to T-3762 were observed.
3. In the offspring, there were no effects on birth rate, viability, differentiation of external development, body weight, sensory function, emotionality, learning ability and reproductive performance in the T-3762 treated groups.
From these results, no-toxic dose levels of T-3762 are considered to be 156 mg/kg for the general toxicity and the reproductive toxicity of parents and for the development of next generation, respectively.

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