Safety and Efficacy Evaluation of Plain OTC-HCL in Acute and Subacute Toxicity Tests and Brucella abortus Infected Mice

• Shubham Tukaram Mane,  
• Rajesh Raghunanth Pharande,*  
• Rajashree Shivkumar Gandge,  
• Sarita U Gulavane,  
• Sushant S Sole,  
• Varsha D Thorat

Abstract

The current study evaluated the safety of Plain OTC-HCL (Oxytetracycline hydrochloride) by acute and subacute toxicity testing and its in vivo efficacy in mice experimentally infected with B. abortus 544 strain. Plain OTC-HCL has an LD50 of greater than 250 mg/kg. In both acute and subacute toxicity evaluations, the hematologic and biochemical data of the drug were within the normal range. Histopathology studies revealed no significant changes in the safety studies. No specific organ damage was observed in either the acute or subacute toxicity studies. In the subacute toxicity study, the drug was administered to the animals over a prolonged period, but the results showed no effects. Mice were injected intraperitoneally with a dose of 3 × 106 CFU of B. abortus 544 in 0.5 ml. The infected mice received Plain OTC-HCl @ 25 mg/kg intravenously daily and alternately for 21 days after day 14 of infection. The logarithmic decreases in B. abortus counts in the liver, lymph nodes and spleen on days 1, 7 and 14 after treatment were used to assess efficacy. The logarithmic decrease in the spleen at different time points was 1.68, 1.58 and 1.93, in that order. After treatment with Plain OTC-HCL, log reductions of 3.05, 1.07 and 3.04 were observed in the liver and 1.39, 1.07 and 2.51 in the lymph nodes. In vivo, the efficacy of Plain OTC-HCL was found to be effective in reducing the infection load in brucella-infected mice.

Keywords

Oxytetracycline, acute and subacute toxicity, haematological and biochemical tests, LD50, Histopathological studies.