The safety profile of alcoholic extract of stem-bark of B. ovalifoliolata was investigated in male Wistar albino rats as per OECD guidelines 407. A total of 24 male Wistar rats were divided into four groups of six rats each. Group 1 served as control and was given 0.3% carboxymethylcellulose, groups 2, 3 and 4 were given alcoholic extract of B. ovalifoliolata @ 100, 500 and 1000 mg/kg respectively in 0.3% carboxymethylcellulose orally for 28 days. The animals were observed daily for clinical signs, mortality, physiological and behavioral changes. Body weights were measured at weekly intervals and various hematological parameters like Hb, PCV, TEC, TLC and serum biochemical profile which included AST, ALT, creatine phosphokinase, creatinine, total protein and antioxidant parameters like TBARS and GSH in liver were estimated at the end of experimental period. There were no clinical signs of abnormality. The weekly body weights, organ weights and hematological parameters did not vary significantly amongst the groups. The mean activity of AST, ALT and CPK, and the concentration of serum creatinine, total protein, TBARS and GSH did not differ significantly among the groups. Histological abnormalities of toxicological significance were not detected in groups 2 and 3. However, mild histopathological alterations were observed in higher dose group 4. In conclusion, the present study revealed that the alcoholic extract of stem-bark of B. ovalifoliolata is safe at lower doses of 100 and 500 mg/kg. Hence, alcoholic extract of stem bark of B. ovalifoliolata is safe and no observed adverse effect level (NOAEL) is found to be 500 mg/kg following repeated oral administration for 28 days in rats.
Keywords: B. ovalifoliolata; hematology; oxidative stress; safety evaluation; serum biochemistry.