title: Reproductive and developmental toxicity of the Ginkgo biloba special extract EGb 761® in mice.
abstract: Extracts from leaves of Ginkgo biloba are among the most widely used and best investigated phytopharmaceuticals worldwide. Almost all clinical trials and the majority of preclinical studies have been performed with a specifically defined extract (EGb 761(®)) standardized to contain confined concentrations of active ingredients and limited quantities of potentially harmful substances. Besides pharmaceutical grade extracts poorly characterized Ginkgo preparations are now increasingly appearing on the market as nutraceuticals. While the safety of EGb 761(®) has been evaluated in an extensive set of toxicology studies, adverse effects of Ginkgo extracts of non-pharmaceutical quality on reproductive functions in mice have been reported in several publications in recent years. As this species has not previously been used in reproductive toxicity studies with EGb 761(®), the present investigation was conducted to examine the influence of EGb 761(®) (100, 350 and 1225mg/kg/day) on embryo-fetal development in mice during the critical period of organogenesis. During external and internal inspection of the fetuses as well as examination of skeletal and soft tissues no embryotoxic properties were noted. In particular, the incidence of malformations, variations or retardations was not increased and the general condition of dams was not influenced. Thus, the no-observed-effect level (NOEL) was above 1225mg/kg/day for the dams and the fetuses.
authors.affiliation: Dr. Willmar Schwabe GmbH & Co. KG, Preclinical Research, 76227 Karlsruhe, Germany. Electronic address: egon.koch@schwabe.de.
authors.forename: Egon
authors.initials: E
authors.lastname: Koch
authors.forename: Michael
authors.initials: M
authors.lastname: Nöldner
authors.forename: Jost
authors.initials: J
authors.lastname: Leuschner
mesh_terms: D000818:Animals; D047108:Embryonic Development / Q000187:drug effects*; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D020441:Ginkgo biloba / Q000009:adverse effects; D051379:Mice; D008815:Mice, Inbred Strains; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology*; D018515:Plant Leaves; D011247:Pregnancy; D012098:Reproduction / Q000187:drug effects*; D000096983:Ginkgo Extract
chemical_list: D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract
keywords: Developmental toxicity; EGb 761(®); Extract characterization; Ginkgo biloba; Mouse; Reproductive toxicity; Teratogenicity