Study on subacute toxicity of intravenous sorbitan trioleate (STO) in Wistar rats

Subacute toxicity of STO was carried out using Wistar rats. STO was administered intravenously at dose levels of 12.5, 50.0 and 200.0 mg/kg for 35 days. No influence on general symptom, body weight, food and water consumption and urinalysis were observed. In 200.0 mg/kg group, the hematological examination revealed anemia corresponding to the histological findings of the bone marrow. Biochemical analysis displayed the significant increase and/or decrease of enzyme values in 200.0 mg/kg group. Morphology showed the swelling, vacuolization and granuloma of the spleen, hepatic granuloma, the increase of reticulum cells and granuloma in the bone marrow. Embolism and thrombus were also found in the pulmonary and tail veins probably due to an artifact caused by the i.v. injection. The toxicity of the STO were observed only in 200.0 mg/kg group of both sexes and any remarkable change other than physical effects were found in other groups under the above dosage. Accordingly, the maximal no-effect level of the STO in Wistar rats was considered to be 50.0 mg/kg.