Investigation of the teratogenic potential of a Zingiber officinale extract in the rat

The teratogenicity of EV.EXT 33, a patented Zingiber officinale extract, wa s examined in Wistar SPF rats according to GLP Guidelines. EV.EXT 33 was ad ministered by oral gavage in concentrations of 100, 333, and 1000 mg/kg, to three groups of 22 pregnant female rats from days 6 to 15 of gestation. Fo r comparison, a fourth group received the vehicle, sesame oil. Body weight and food and water intake were recorded during the treatment period. The ra ts were killed on day 21 of gestation and examined for standard parameters of reproductive performance. The fetuses were examined for signs of teratog enic and toxic effects. EV.EXT 33 was well tolerated. No deaths or treatment-related adverse effect s were observed. Weight gain and food consumption were similar in all group s during gestation. Reproductive performance was not affected by treatment with EV.EXT 33. The examination of fetuses for external, visceral, and skel etal changes showed no embryotoxic or teratogenic effects of EV.EXT 33. Based on these results, it was concluded that EV.EXT 33, when administered to pregnant rats during the period of organogenesis, caused neither materna l nor developmental toxicity at daily doses of up to 1000 mg/kg body weight . (C) 2001 Elsevier Science Inc. All rights: reserved.