title: A toxicological safety assessment of a standardized extract of Sceletium tortuosum (Zembrin®) in rats.
abstract: A well-characterized standardized hydroethanolic extract of a traditionally recognized mak (mild) variety of Sceletium tortuosum, a South African plant with a long history of traditional ingestion, is marketed under the trade name Zembrin(®) as an ingredient for use in functional foods and dietary supplements. It is standardized to contain 0.35-0.45% total alkaloids (mesembrenone and mesembrenol ≥60%, and mesembrine <20%). A 14-day repeated oral toxicity study was conducted at 0, 250, 750, 2500, and 5000 mg/kg bw/day. A 90-day subchronic repeated oral toxicity study was conducted at 0, 100, 300, 450, and 600 mg/kg bw/day. Because S. tortuosum has a long history of human use for relieving stress and calming, a functional observation battery, including spontaneous locomotor activity measured using LabMaster ActiMot light-beam frames system, was employed. Several parameters, such as locomotion, rearing behavior, spatial parameters, and turning behavior were investigated in the final week of the study. No mortality or treatment-related adverse effects were observed in male or female Crl:(WI)BR Wistar rats in the 14- or 90-day studies. In the 14- and 90-day studies, the NOAELs were concluded as 5000 and 600 mg/kg bw/d, respectively, the highest dose groups tested.
authors.affiliation: AIBMR Life Sciences, Inc., 4117 South Meridian, Puyallup, WA 98373, USA. Electronic address: tim@aibmr.com.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Murbach
authors.affiliation: Toxi-Coop Zrt., Deres u. 10/A, H-1124 Budapest, Hungary.
authors.forename: Gábor
authors.initials: G
authors.lastname: Hirka
authors.affiliation: Toxi-Coop Zrt., Deres u. 10/A, H-1124 Budapest, Hungary.
authors.forename: Ilona Pasics
authors.initials: IP
authors.lastname: Szakonyiné
authors.affiliation: HG&H Pharmaceuticals (Pty) Ltd., Bryanston 2191, South Africa.
authors.forename: Nigel
authors.initials: N
authors.lastname: Gericke
authors.affiliation: AIBMR Life Sciences, Inc., 4117 South Meridian, Puyallup, WA 98373, USA.
authors.forename: John R
authors.initials: JR
authors.lastname: Endres
mesh_terms: D035722:Aizoaceae / Q000633:toxicity*; D000470:Alkaloids / Q000032:analysis; D000818:Animals; D001772:Blood Cell Count; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D008297:Male; D016488:Medicine, African Traditional; D010936:Plant Extracts / Q000633:toxicity*; D051381:Rats; D017208:Rats, Wistar
chemical_list: D000470:Alkaloids; D010936:Plant Extracts
keywords: Anxiolytic; Safety assessment; Sceletium tortuosum; Stress; Toxicity; Zembrin