title: Safety assessment of a hydroethanolic extract of Caralluma fimbriata.
abstract: This toxicological assessment evaluated the safety of a hydroethanolic extract prepared from Caralluma fimbriata (CFE), a dietary supplement marketed worldwide as an appetite suppressant. Studies included 2 in vitro genotoxicity assays, a repeated dose oral toxicity study, and a developmental study in rats. No evidence of in vitro mutagenicity or clastogenicity surfaced in the in vitro studies at concentrations up to 5000 μg of extract/plate (Ames test) or 5000 μg of extract/mL (chromosomal aberration test). No deaths or treatment-related toxicity were seen in the 6-month chronic oral toxicity study in Sprague-Dawley rats conducted at 3 doses (100, 300, and 1000 mg/kg body weight (bw)/d). The no observed effect level for CFE in this study was considered to be 1000 mg/kg bw/d. A prenatal developmental toxicity study conducted at 3 doses (250, 500, and 1000 mg/kg bw/d) in female Sprague-Dawley rats resulted in no treatment-related external, visceral, or skeletal fetal abnormalities, and no treatment-related maternal or pregnancy alterations were seen at and up to the maximum dose tested. CFE was not associated with any toxicity or adverse events.
authors.affiliation: AIBMR Life Sciences, 4117 South Meridian, Puyallup, WA 98373, USA. Email: antoinette@aibmr.com.
authors.forename: Antoinette Y
authors.initials: AY
authors.lastname: Odendaal
authors.forename: Narendra S
authors.initials: NS
authors.lastname: Deshmukh
authors.forename: Tennille K
authors.initials: TK
authors.lastname: Marx
authors.forename: Alexander G
authors.initials: AG
authors.lastname: Schauss
authors.forename: John R
authors.initials: JR
authors.lastname: Endres
authors.forename: Amy E
authors.initials: AE
authors.lastname: Clewell
mesh_terms: D000818:Animals; D029062:Apocynaceae; D001067:Appetite Depressants / Q000633:toxicity*; D000431:Ethanol / Q000737:chemistry; D005260:Female; D008297:Male; D009152:Mutagenicity Tests; D019055:No-Observed-Adverse-Effect Level; D010936:Plant Extracts / Q000633:toxicity*; D011247:Pregnancy; D051381:Rats; D017207:Rats, Sprague-Dawley; D012997:Solvents / Q000737:chemistry; D036401:Toxicity Tests, Chronic; D014867:Water / Q000737:chemistry
chemical_list: D001067:Appetite Depressants; D010936:Plant Extracts; D012997:Solvents; D014867:Water; D000431:Ethanol
keywords: Caralluma fimbriata; NOEL; and developmental toxicity studies; appetite suppressant; chronic; genotoxicity; safety assessment