title: Safety assessment of a traditionally used extract from leaves of Boldoa purpurascens.
abstract: BACKGROUND
  Boldoa purpurascens Cav. (Nyctaginaceae) is a plant species used in traditional medicine in Cuba as a diuretic.
  
  
  OBJECTIVE
  The aim of the present investigation was to evaluate the safety profile of a hydroalcoholic extract from leaves of Boldoa purpurascens.
  
  
  METHODS
  First, an experimental study to assess the oral acute toxicity at a dose of 2000mg/kg body weight of the extract was carried out. Potential genotoxicity of the extract was evaluated using the Ames test and the micronucleus induction assay in mouse bone marrow. In the Ames test a concentration range of 50, 100, 150, 300 and 500µg/plate was tested. In the micronucleus induction assay, doses of 500, 1000 and 2000mg/kg of body weight were tested. For completeness, since the extract contains saponins, the evaluation of the hemolytic activity, ocular and skin irritation were included.
  
  
  RESULTS
  No signs or symptoms of toxicity were observed in the oral acute toxicity test (body weight at baseline, seven days and end of the experiment of 236.41±20.07, 256.81±30.44 and 240.02±26.16 respectively for the treated group). The hydroalcoholic extract from the leaves was not mutagenic in the Ames test, and no genotoxicity was observed in the micronucleus assay. A hemolysis test at concentration of 1mg/mL confirmed hemolytic activity, which is not a safety concern since saponins are not absorbed after oral administration. In order to evaluate the percentage of protein denaturation, the ocular irritability index was calculated. The extract was found to be irritating. Finally, skin irritability was evaluated and the irritation index was equal to zero.
  
  
  CONCLUSIONS
  Based on the toxicological evaluation of a traditionally used hydroalcoholic extract from the leaves of Boldoa purpurascens we can confirm the safety of its oral use.
authors.affiliation: Department of Pharmacy, Central University "Marta Abreu" of Las Villas, Cuba.
authors.forename: Y Hernandez
authors.initials: YH
authors.lastname: Ortega
authors.affiliation: Department of Pharmacy, Central University "Marta Abreu" of Las Villas, Cuba.
authors.forename: D M González
authors.initials: DMG
authors.lastname: Mosquera
authors.affiliation: Department of Pharmacy, Central University "Marta Abreu" of Las Villas, Cuba.
authors.forename: S
authors.initials: S
authors.lastname: Galapththi
authors.affiliation: Institute of Pharmacy and Food, University of Havana, Cuba.
authors.forename: B Tamargo
authors.initials: BT
authors.lastname: Santos
authors.affiliation: BioCubaPharma, Havana, Cuba.
authors.forename: G Sierra
authors.initials: GS
authors.lastname: González
authors.affiliation: Natural Products & Food Research and Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Belgium.
authors.forename: K
authors.initials: K
authors.lastname: Foubert
authors.affiliation: Natural Products & Food Research and Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Belgium.
authors.forename: L
authors.initials: L
authors.lastname: Pieters
authors.affiliation: Toxicology and Cancer Biology Research Group (GTOX), Louvain Drug Research Institute, Université catholique de Louvain, Belgium; Faculty of Health Sciences, University Arturo Prat, Iquique, Chile.
authors.forename: P Buc
authors.initials: PB
authors.lastname: Calderon
authors.affiliation: Natural Products & Food Research and Analysis (NatuRA), Department of Pharmaceutical Sciences, University of Antwerp, Belgium. Electronic address: Sandra.Apers@Uantwerpen.be.
authors.forename: S
authors.initials: S
authors.lastname: Apers
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001854:Bone Marrow Cells / Q000187:drug effects / Q000473:pathology; D004269:DNA, Bacterial / Q000187:drug effects / Q000235:genetics; D003877:Dermatitis, Contact / Q000209:etiology / Q000473:pathology; D005123:Eye / Q000187:drug effects / Q000378:metabolism; D005136:Eye Proteins / Q000378:metabolism; D005260:Female; D006461:Hemolysis / Q000187:drug effects; D008297:Male; D008807:Mice, Inbred BALB C; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D015162:Micronucleus Tests; D009154:Mutation; D039281:Nyctaginaceae / Q000737:chemistry / Q000633:toxicity*; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage / Q000302:isolation & purification / Q000633:toxicity*; D018515:Plant Leaves / Q000737:chemistry / Q000633:toxicity*; D010946:Plants, Medicinal; D011489:Protein Denaturation; D011817:Rabbits; D017207:Rats, Sprague-Dawley; D017208:Rats, Wistar; D018570:Risk Assessment; D023422:Skin Irritancy Tests; D012997:Solvents / Q000737:chemistry; D013997:Time Factors; D023382:Toxicity Tests, Acute
chemical_list: D004269:DNA, Bacterial; D005136:Eye Proteins; D010936:Plant Extracts; D012997:Solvents
keywords: Boldoa purpurascens; Genotoxicity; Nyctaginaceae; Oral acute toxicity; Safety assessment