Nakada H, Kawamura Y, Shibata T, Nojima Y, Sanzen T, Yoshida K, Yoneda T
Jpn J Antibiot. 1986 Sep;39(9):2285-300.
A subacute toxicity study on T-2588 was carried out in juvenile rats (6 days-old 48 males and 48 females) by oral administrations at dose levels of 250, 500 and 1,000 mg/kg/day for 1 month. The results obtained were summarized below. During the study, there were no clinical signs considered to be related to the treatment. There were no T-2588-related abnormalities in urinalysis, hematological examinations, biochemical examinations and ophthalmological examinations. Slight increases in relative liver and kidney weights were observed in the 1,000 mg/kg-treated group and slight increases in relative kidney weight were detected in the 500 mg/kg-treated female group. Histologically, however, T-2588-related abnormality was not observed. The maximum safety dose of T-2588 was estimated to be 250 mg/kg/day. In addition to the above examinations, male reproductive performance was examined in the group administered with a dose level of 1,000 mg/kg/day. No adverse effects were observed in male fertility and F1 generation.
在幼鼠(6日龄,48只雄性和48只雌性)中开展了T - 2588的亚急性毒性研究,通过口服给药,剂量水平分别为250、500和1000毫克/千克/天,持续1个月。所得结果总结如下。在研究期间,未观察到被认为与治疗相关的临床症状。在尿液分析、血液学检查、生化检查和眼科检查中未发现与T - 2588相关的异常。在1000毫克/千克治疗组中观察到相对肝脏和肾脏重量略有增加,在500毫克/千克治疗的雌性组中检测到相对肾脏重量略有增加。然而,组织学上未观察到与T - 2588相关的异常。T - 2588的最大安全剂量估计为250毫克/千克/天。除上述检查外,还对给予1000毫克/千克/天剂量水平的组进行了雄性生殖性能检查。在雄性生育力和F1代中未观察到不良影响。