Ginseng is a widely used medicinal herb that has long been famous for its healing properties. The pharmacologically active compounds in ginseng are called ginsenosides, referred to as ginseng saponins.
Ginsenoside Rg3 is a best-known ginsenosides extracted from red ginseng. Decades of studies have found that ginsenoside Rg3 can not only slow or arrest the growth of many tumor types but help enhance the therapeutic effects of primary treatments like chemotherapy and radiotherapy.
Toxicity testing, also known as safety assessment, is an important part of preclinical development and animal studies are used to expect and determine safe doses of exposure in humans.
Generally speaking, ginsenoside Rg3 is safe to consume. However, there is still a need to know the maximal safe doses of exposure.
A recent study published in the journal Regulatory Toxicology and Pharmacology examined the toxicity of oral administration of ginsenoside Rg3 for 26 weeks in Beagle dogs that are usually used for preclinical studies.
In the experiment, a total of 40 Beagle dogs of 4.4-6.4 kg were assigned to the dosing group and the control group. Beagle dogs in the dosing group were orally given ginsenoside Rg3 of 0, 7, 20, or 60 mg/kg continuously, while the control group received an empty vehicle capsule. The 26-week oral toxicity test is followed by a 4-week recovery observation.
Researchers monitored key clinical parameters that are linked to drug-related adverse events like weight, food intake, urinalysis, ophthalmic assessments, and electrocardiogram examinations. There were no clear or dose-dependent changes found in these parameters.
Serum biochemical and hematological parameters are essential indicators for detecting potential acute or chronic toxicity to the liver or kidneys. Researchers found that ginsenoside Rg3 administration caused no toxicological effects.
Though some changes were observed in animals receiving ginsenoside Rg3, researchers determined that they were not toxicological events from ginsenoside Rg3 administration.
However, researchers did find the toxicity of high-dose ginsenoside Rg3 administration.
Changes in organ weight are another potential sign of impaired organ functionality. Researchers observed a significant increase in absolute kidney weight in Beagle dogs receiving a high-dose (60 mg/kg) of ginsenoside Rg3. The side effects disappeared during the four-week recovery period.
The side effects of organ weight revealed that ginsenoside Rg3 administration at 60 mg/kg can cause toxic effects in dogs. Thus, the study determined that the no observed adverse effect level of ginsenoside Rg3 is considered to be 20 mg/kg.
This toxicity testing provides a glimpse of the potentially toxic effects of ginsenoside Rg3. Kidney damage shall be a concern for high-dose ginsenoside Rg3 administration.
Gao, Yonglin & Wang, Guangfei & Wang, Tong & Li, Guisheng & Lin, Jian & Sun, Liqin & Wu, Xuran & Sun, Xilin & Wang, Hongbo & Li, Chunmei & Tian, Jingwei & Zhu, Jing & Wang, Kezhou & Cho, Susan. (2019). A 26-week 20(S)-ginsenoside Rg3 oral toxicity study in Beagle dogs. Regulatory Toxicology and Pharmacology. 110. 104522. 10.1016/j.yrtph.2019.104522.