Pre Clinical Safety Assessment of AYUSH Carctol S through Acute and Sub Chronic Oral Toxicity Study: Safety Assessment of AYUSH Carctol S

AYUSH Carctol S is a coded Ayurvedic compound formulation developed for treatment of cancer. The safety of the test drug was not established in the experimental animals yet, hence the present study was highlighted the same through acute and sub-chronic toxicity studies. The acute oral toxicity study of the test drug was performed in swiss albino mice with a dose of 2600 mg/kg. Similarly, the sub-chronic oral toxicity study was carried out in wistar rats with three different test doses i.e., 180 mg/kg, 900 mg/kg, and 1800 mg/kg. Cage side observations, feed intake, body weight, gross morphology, and necropsy findings of the animals of test drug-treated animals were normal and no mortality was reported in both either study. During the sub-chronic toxicity study, the hematological and biochemical parameters of AYUSH Carctol S-treated animals were found to be non-significant when compared to the control animals. Further, the histopathological analysis of major organs of AYUSH Carctol S 1800 mg/kg treated animals showed no major lesions and treatment-related changes. The test drug was considered to be nontoxic during the acute and sub-chronic oral toxicity studies. The LD50 of AYUSH Carctol S estimated during the acute toxicity was found as 2600 mg/kg and the sub-chronic safety dose i.e., NOAEL is up to 1800 mg/kg.