ASSESMENT OF ACUTE AND SUB-ACUTE TOXICITY OF HYDRO-ETHANOLIC EXTRACT OF Catharanthus roseus LEAVES EXTRACT

Objective: This study investigated the acute and subacute toxicity of hydro-ethanolic extract
of Catharanthus roseus leaves in rats for evaluating its safety profile.
Methods: Catharanthus roseus leaves extract (CRLE) for the acute (2000mg/kg) and subacute
(100, 200 and 400 mg/kg) toxicity studies were administered orally to rats according the
guidelines of Organization for Economic Cooperation and Development (OECD),
respectively. Food and water intake as well as body and organ weight of animals were
recorded. Signs of toxicity were assessed, and hematological, biochemical and
histopathological analysis were performed.
Results: In the acute toxicity study, a single dose of the hydro-ethanolic extract of
Catharanthus roseus leaves at 2000 mg/kg caused no mortality in the animals, suggesting that
the median lethal dose is greater than 2000 mg/kg. In the subacute toxicity study,
administration of the extract for 28 days, at all doses, caused no significant changes in the
body weights or organ weights of rats in the treated groups when compared with the control
group. In addition, hematological and biochemical parameters also revealed no toxic effects
of the extract on rats. Histological sections of the liver and kidney from test animals showed
no signs of degeneration. On the basis of acute and sub-acute toxicity studies, the minimal
effective dose of 200mg/kg is taken for efficacy studies.