title: Acute and sub-acute oral toxicity assessment of the methanolic extract from leaves of Hibiscus rosa-sinensis L. in mice.
abstract: BACKGROUND
  The leaves of Hibiscus rosa-sinensis L. (Malvaceae) are used for the treatment of dysentery and diarrhea, to promote draining of abscesses and as analgesic agent in the traditional medicine of Cook Islands, Haiti, Japan and Mexico.
  
  
  OBJECTIVE
  The present study investigated the oral acute and subacute toxicity of methanol leaf extract of H. rosa-sinensis in mice.
  
  
  METHODS
  In the acute toxicity study, a single oral dose of 2000 mg/kg of extract was given to five mice at 48 h intervals. Animals were observed individually for any clinical signs of toxicity or mortality for 14 days. In the sub-acute toxicity study, mice were treated with 400 mg/kg and 800 mg/kg doses of the extract for 14 days. The hematological and biochemical parameters and histopathology of liver and kidneys of animals were studied at the end of the experiment.
  
  
  RESULTS
  For acute treatment, the extract did not reveal any signs of toxicity or mortality in any animal, during the 14 days observation period. The LD50 of extract was estimated to be greater than 2000 mg/kg. In the sub-acute toxicity study, administration of 400 mg/kg and 800 mg/kg doses of extract to mice for two weeks did not reveal any marked adverse effects on hematological, biochemical parameters and histopathology of liver and kidney in the 400 mg/kg group. However, hepato-renal toxicity as evidenced by elevated levels of alanine aminotransferase, aspartate aminotransferase, total and indirect bilirubin, urea and creatinine was seen in the animals that received 800 mg/kg dose of extract for 14 days. In addition, in the same group of animals, the histological assessments of liver and kidney also showed various adverse effects viz. dilated sinusoids, apoptotic nuclei and inflammatory infiltrate inside sinusoidal capillaries in the liver, and marked the disorganization of tubules and glomeruli, and enlarged interstitial spaces in the kidney.
  
  
  CONCLUSIONS
  The results of this study suggest that for traditional medicinal purpose, only a low dose of H. rosa-sinensis leaf extract (i.e., 400 mg/kg) should be considered as safe.
authors.affiliation: Department of Zoology, North-Eastern Hill University, Shillong, Meghalaya, India.
authors.forename: Purobi
authors.initials: P
authors.lastname: Nath
authors.affiliation: Department of Zoology, North-Eastern Hill University, Shillong, Meghalaya, India.
authors.forename: Arun K
authors.initials: AK
authors.lastname: Yadav
keywords: Acute toxicity; Hibiscus rosa-sinensis L; Malvaceae; histopathology; subacute toxicity