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A toxicological safety assessment of a standardized extract of Sceletium tortuosum (Zembrin®) in rats.

Authors :
Murbach TS
Hirka G
Szakonyiné IP
Gericke N
Endres JR
Source :
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association [Food Chem Toxicol] 2014 Dec; Vol. 74, pp. 190-9. Date of Electronic Publication: 2014 Oct 06.
Publication Year :
2014

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.<br /> (Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Details

Language :
English
ISSN :
1873-6351
Volume :
74
Database :
MEDLINE
Journal :
Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association
Publication Type :
Academic Journal
Accession number :
25301237
Full Text :
https://doi.org/10.1016/j.fct.2014.09.017