title: Safety evaluation of Bon-santé cleanser® polyherbal in male Wistar rats.
abstract: BACKGROUND
  The potential harm of medicinal herbs has been recently observed following herbal toxicity studies after ingestion of polyherbal remedies. This was the rationale for the food and drug regulatory agency decision for thorough safety evaluation of herbal medicines. Androgenic, antipyretic, analgesic and anti-inflammatory potentials as well as chemical compositions of extracts of massularia acuminata, terminalia ivorensis, anogeissus leiocarpus and macuna pruriens respectively have been documented. Thus, Bon-santé cleanser® (BSC) is formulated from these medicinal plants with the intention to boost body hormones and energizes the body. Considering the wide usage of BSC, we investigated on its safety in male Wistar rats.
  
  
  METHODS
  Thirty-two male Wistar rats weighing 201.9 ± 7.5 g were grouped into four treatment groups of eight per group. Group I, (control) received distilled water (10 ml/kg). Groups II-IV received 250 mg/kg, 500 mg/kg and 1000 mg/kg of BSC per oral respectively. Each group was treated for sixty days.
  
  
  RESULTS
  Acute toxicity test, in male Wistar albino mice, showed that LD50 was 600 mg/kg via i.p. while 4 g/kg was nonlethal after oral administration in mice. Hepatic and renal biomarker enzymes were unaltered in all rats. Increased in PCV (p <0.05) was observed at 500 mg/kg. BSC modulates antioxidants biomarkers following sub-chronic administration and increased serum Na(+) (p >0.05). BSC at 1000 mg/kg caused mild inflammation of the liver and heart but not kidneys histologically.
  
  
  CONCLUSIONS
  BSC has been found to be relatively safe in Wistar rats. Although, our findings indicate that herbal therapy with BSC should be done with caution as a mild alteration in the liver and heart architectures were observed.
authors.affiliation: Department of Pharmacology, Benjamin Carson (Snr.) School of Medicine, Babcock University, Ilisan Remo, Ogun, Nigeria.|Department of Pharmacology, Therapeutics, and Toxicology, College of Medicine, Idi-Araba Campus, University of Lagos, Lagos, Nigeria.
authors.forename: O E
authors.initials: OE
authors.lastname: Kale
authors.affiliation: Department of Pharmacology, Therapeutics, and Toxicology, College of Medicine, Idi-Araba Campus, University of Lagos, Lagos, Nigeria. awodeleo@gmail.com.
authors.forename: O
authors.initials: O
authors.lastname: Awodele
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000032:analysis; D007668:Kidney / Q000737:chemistry / Q000187:drug effects; D007928:Lethal Dose 50; D015227:Lipid Peroxidation / Q000187:drug effects; D008099:Liver / Q000737:chemistry / Q000187:drug effects; D008297:Male; D051379:Mice; D008517:Phytotherapy; D010936:Plant Extracts / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar; D023382:Toxicity Tests, Acute
chemical_list: D015415:Biomarkers; D010936:Plant Extracts
keywords: Acute oral and intraperitoneal toxicity; Bon-santé cleanser®; Herbotherapy; Polyherbal; Safety study