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.

Bioprospecting the antimicrobial, antibiofilm and antiproliferative activity of Symplocos racemosa Roxb. Bark phytoconstituents along with their biosafety evaluation and detection of antimicrobial components by GC-MS

“…To add up on the bioactive potential of the plant, the flavonoids were screened for their cytotoxicity against three cancerous cell lines and our results are in consonance with those obtained for compounds of Acanthus hirsutus Boiss (11.17-700 µg/ml), Euphorbia hirta (625 µg/ml) [52,53] and some naturally occurring quinones [54] . These results are in consonance with other studies where plant extracts were found to be non toxic [12,[16][17][18].…”

“…Since the potential of its aqueous extract has been reported earlier in Sood et al [15], the present study has thus been further extended to evaluate the best organic solvent and hence the major groups of bioactive phytoconstituents. The organic extract and active phytoconstituents have been tested for their various bioactivities such as antimicrobial single dose (5000 mg/ kg)] has also been determined by acute oral toxicity test using Swiss albino mice (males and females) weighing between 25 g to 35 g and aged 8 to 10 weeks [12,[16][17][18].…”

A Toxicological Evaluation of Methylliberine (Dynamine®)

“…e studies herein described were conducted in compliance with OECD Principles of Good Laboratory Practice (GLP) [6], except for the following deviation: analytical control of the test item formulations for homogeneity and stability was not performed because no appropriate test method has been validated. We have described the OECD methods and laboratory standard operating procedures (SOP) used in previous works [7][8][9][10][11][12], and summarize them again, in brief, below.…”

Psychophysiological Effects of Zembrin&lt;sup&gt;&#174;&lt;/sup&gt;Using Quantitative EEG Source Density in Combination with Eye-Tracking in 60 Healthy Subjects. A Double-Blind, Randomized, Placebo-Controlled, 3-Armed Study with Parallel Design

“…Extract Sceletium tortuosum (Zembrin ® ) has been shown to be safe and well tolerated in pre-clinical [6] and clinical studies [7]. The acute effects of extract Sceletium tortuosum (Zembrin ® ) administration in 16 healthy young adults was studied in a pharmaco-fMRI study focused on anxiety-related activity in the amygdala and its connected neuro-circuitry.…”