Abstract
Acute, subacute and chronic toxicities of sultamicillin (SBTPC), a mutual prodrug of sulbactam and ampicillin were evaluated in Sprague-Dawley rats or ICR mice.
The acute oral LD50 of SBTPC were estimated to be greater than 10000 mg/kg in rats and mice.
In the subacute oral toxicity test, all rats treated with SBTPC (1000, 300, 100, 30mg/kg) for 1 month were well tolerated. Occasional soft stools were noted in the treated groups. The highest dose level (1000mg/kg) of SBTPC produced mild growth inhibition, slight decrease of the liver weight and enlarged cecum and a deposition of glycogen-like droplets in the hepatic cell cytoplasm without any functional abnormality and morphological lesions. The non-toxic dose of SBTPC is considered to be 300mg/kg.
In the chronic toxicity test, the rats were treated orally with SBTPC (1000, 300, 100 and 30mg/kg) for 6 months. Deaths were noted in the high dose groups (1000 and 300 mg/kg). Other results were comparable to those in the subacute toxicity test. The non-toxic dose in the chronic toxicity test with SBTPC is considered to be 100mg/kg.
