Preclinical Safety Assessment of Hydro-Alcoholic Extract of Cycas Pectinata Buch.-Ham.

Abstract

Objectives
To assess the acute oral toxicity and safety profile of hydroalcoholic extract of Cycas pectinata (Cycadaceae) in female mice according to OECD Guideline.
Methods
The hydroalcoholic extract of C. pectinata (CPE) was administered orally to female mice at graded doses up to 2000 mg/kg body weight. Clinical signs of toxicity, behavioral changes, morbidity and mortality were observed for 14 days. Body weight, food intake and water consumption were recorded throughout the study. At the end of the experimental period, blood samples were collected for hematological and biochemical analysis and vital organs were examined histopathologically for systemic toxicity.
Results
No mortality or significant behavioral abnormalities were observed at any tested dose. Food and water intake and body weight gain were comparable to the control group. The hematological parameters were within the normal physiological range showing no deleterious effect to the blood components. Biochemical analysis revealed mild, dose-dependent fluctuations in creatinine and ALT at the highest dose (2000 mg/kg), but all values were within reference limits. Histopathological examination of the kidney, spleen and liver revealed preserved organ architecture with mild, non-specific changes.
Conclusions
The hydroalcoholic extract of Cycas pectinata did not show any significant acute toxicity in mice even at doses up to 2000 mg/kg. The results indicate a large safety margin and support the safe oral use of the extract and provide a basis for further pharmacological investigation.