title: Safety profile of Hoodia gordonii extract: rabbit prenatal developmental toxicity study.
abstract: Hoodia gordonii extract was orally administered by gavage to groups of 22 female New Zealand white rabbits from day 3-28 after mating at doses of 0 (control), 3, 6 or 12 mg/kg bodyweight/day. These doses were reached by a dose escalation phase between days 3 and 7 after mating. As well as a vehicle control group, a control group pair-fed to the high dose was also included. On day 29 after mating the females were euthanized and examined. Treatment at 6 or 12 mg/kg/day was associated with a dose-related reduction in feed intake and bodyweight gain. Feed consumption and bodyweight gain was unaffected at 3mg/kg/day. In spite of marked maternal effects at 12 mg/kg/day, reproductive indices were unaffected at all doses and there were no effects on fetal or placental weights and no morphological changes in the fetuses. The no-observed-effect level (NOEL) for developmental effects was therefore 12 mg/kg/day, and the maternal NOEL was 3mg/kg/day. At doses that caused marked maternal effects, H. gordonii extract did not affect embryonic or fetal development in a species that is considered predictive of developmental toxicity in man.
authors.affiliation: Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire MK44 1LQ, UK. matthew.dent@unilever.com
authors.forename: M P
authors.initials: MP
authors.lastname: Dent
authors.forename: A P M
authors.initials: AP
authors.lastname: Wolterbeek
authors.forename: P J
authors.initials: PJ
authors.lastname: Russell
authors.forename: R
authors.initials: R
authors.lastname: Bradford
mesh_terms: D000284:Administration, Oral; D000818:Animals; D029062:Apocynaceae / Q000737:chemistry*; D001067:Appetite Depressants / Q000493:pharmacokinetics / Q000633:toxicity*; D001835:Body Weight / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D004622:Embryo, Mammalian / Q000187:drug effects; D047108:Embryonic Development / Q000187:drug effects*; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D020567:Fetal Weight / Q000187:drug effects; D006207:Half-Life; D008297:Male; D018811:Maternal Exposure; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D010920:Placenta / Q000187:drug effects; D010936:Plant Extracts / Q000145:classification / Q000493:pharmacokinetics / Q000633:toxicity*; D011247:Pregnancy; D011817:Rabbits; D012098:Reproduction / Q000187:drug effects; D012744:Sex Ratio; D013723:Teratogens / Q000145:classification / Q000493:pharmacokinetics / Q000633:toxicity*
chemical_list: D001067:Appetite Depressants; D010936:Plant Extracts; D013723:Teratogens