Safety assessment of a hydroethanolic extract of Caralluma fimbriata

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

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Apocynaceae*
  • Appetite Depressants / toxicity*
  • Ethanol / chemistry
  • Female
  • Male
  • Mutagenicity Tests
  • No-Observed-Adverse-Effect Level
  • Plant Extracts / toxicity*
  • Pregnancy
  • Rats
  • Rats, Sprague-Dawley
  • Solvents / chemistry
  • Toxicity Tests, Chronic
  • Water / chemistry

Substances

  • Appetite Depressants
  • Plant Extracts
  • Solvents
  • Water
  • Ethanol