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Int J Toxicol. 2013 Sep-Oct;32(5):385-94. doi: 10.1177/1091581813492827. Epub 2013 Jun 14.

Safety assessment of a hydroethanolic extract of Caralluma fimbriata.

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1
AIBMR Life Sciences, 4117 South Meridian, Puyallup, WA 98373, USA. Email: antoinette@aibmr.com.

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.

KEYWORDS:

Caralluma fimbriata; NOEL; and developmental toxicity studies; appetite suppressant; chronic; genotoxicity; safety assessment

PMID:
23771637
DOI:
10.1177/1091581813492827
[Indexed for MEDLINE]
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