Journal
FOOD AND CHEMICAL TOXICOLOGY
Volume 131, Issue -, Pages -Publisher
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.fct.2019.110586
Keywords
Botanical dietary supplements; Ginkgo biloba extract; Terpene trilactones; Flavonols; Flavonol glycosides; Systemic exposure
Categories
Funding
- MRIGlobal [HHSN273201400022C]
- Battelle Memorial Institute [HHSN273201400027C, HHSN273201400015C]
Ask authors/readers for more resources
Ginkgo biloba extract (GBE) is a popular botanical dietary supplement used worldwide and the safety of use is a public health concern. While GBE is a complex mixture, the terpene trilactones and flavonol glycosides are believed to elicit the pharmacological and/or toxicological effects of GBE. In a National Toxicology Program (NTP) 2-year rodent bioassay with GBE, hepatotoxicity was observed in rodents (>= 100 mg/kg in rats, >= 200 mg/kg in mice). Subsequently, questions arose about whether or not the GBE used in NTP studies was representative of other GBE products and how rodent doses are related to human doses. To address these, we generated systemic exposure data for terpene trilactones in male rats following oral administration of 30, 100, and 300 mg/kg GBE test article from the 2-year bioassay. Dose-normalized C-max and AUC(infinity) for terpene trilactones from the current study were within 5-fold of published rodent studies using a standardized GBE preparation. Comparison of our rat systemic exposure data at 100 mg/kg GBE to published human data following ingestion of 240 mg GBE-containing product showed that the rat/human exposure multiple was 3-22, for terpene trilactones. These data demonstrate the relevance of NTP rodent toxicity data to humans.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available