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Lagenaria siceraria (Cucurbitaceae) is traditionally known to be used for the treatment of diabetes, ulcer, jaundice, cardiovascular disease, hemorrhoids, and colitis. This study involves evaluation of acute and subacute toxicity of methanolic extract of L. siceraria fruit (MELSF) in rats for assessment of its safety profile. For acute oral toxicity, single dose (2000 mg/kg body weight) of extract was administered in female Wister rats while in the subacute study the extract was given at doses of 250, 500, and 1000 mg/kg orally over 28 d in male and female rats. No evidence of toxicity was observed in animals when acutely exposed to MELSF, implying that the LD50 is higher than 2000 mg/kg body weight. Further, repeated administration of the extract for 28 d did not alter any hematological and biochemical parameters and no significant changes were observed in organ and body weight of control and treated groups. Histopathological assessment was normal in kidney and liver. Thus, the present investigation shows that MELSF, at dosage levels up to 1000 mg/kg, is nontoxic and can show protection of some body tissues when administered for 28 d and therefore can be considered safe. This study supports the application of L. siceraria in traditional medicine. [ABSTRACT FROM AUTHOR]