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Repeated-dose 26-week oral toxicity study of ginsenoside compound K in Beagle dogs
Chunmei Li1, Zhezhe Wang1, Tong Wang2
1School of Pharmacy, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University), Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Yantai University, Yantai, 264005, PR China.
Ethnopharmacological Relevance:
Ginsenoside compound K (CK), a product produced by the intestinal bacteria-mediated breakdown of ginsenoside, exhibits a wide array of pharmacological activities against diverse targets. However, few of preclinical safety evaluation of CK is reported.
Aims Of The Study:
The present study therefore sought to assess the toxicity of oral CK in Beagle dogs over a 26-week period.
Material And Methods:
All dogs received 4, 12, or 36 mg/kg oral CK doses for 26 weeks with regular monitoring, followed by a 4-week recovery period. Animals were monitored through measurements of temperature, weight, food intake, blood chemistry and hematological findings, electrocardiogram (ECG) measurements, urinalysis, gross necropsy and organ weight and tissue histopathology.
Results:
Animals in the 36 mg/kg group exhibited an apparent reduction in body weight over the study period, in addition to the presence of focal liver necrosis and increased plasma enzyme levels (alanine aminotransferase, ALT; alkaline phosphatase, ALP) consistent with hepatotoxicity, although there was some evidence suggesting this toxicity was reversible. Animals in the 4 and 12 mg/kg groups did not exhibit any apparent toxicity for any measured parameters.
Conclusion:
These results thus indicate that the no observed adverse effect level (NOAEL) in dogs is 12 mg/kg.
Insights
Ginsenoside compound K (CK) showed no toxicity in dogs at 12 mg/kg over 26 weeks. Higher doses (36 mg/kg) caused reversible liver toxicity, establishing a no observed adverse effect level (NOAEL) of 12 mg/kg for oral CK.
Area of Science:
- Pharmacology and Toxicology
- Natural Products Research
- Preclinical Safety Assessment
Background:
- Ginsenoside compound K (CK), a metabolite of ginsenoside, possesses diverse pharmacological activities.
- Limited preclinical safety data exists for CK, necessitating further evaluation.
Purpose of the Study:
- To assess the oral toxicity of Ginsenoside compound K (CK) in Beagle dogs over a 26-week period.
- To determine the no observed adverse effect level (NOAEL) of CK in this animal model.
Main Methods:
- Beagle dogs were administered oral doses of CK at 4, 12, or 36 mg/kg for 26 weeks, followed by a 4-week recovery period.
- Comprehensive monitoring included body weight, food intake, hematology, blood chemistry, ECG, urinalysis, necropsy, organ weights, and histopathology.
Main Results:
- The 36 mg/kg group exhibited reduced body weight, focal liver necrosis, and elevated liver enzymes (ALT, ALP), indicating hepatotoxicity.
- Hepatotoxicity observed at the highest dose showed signs of reversibility.
- No apparent toxicity was observed in the 4 and 12 mg/kg groups across all measured parameters.
Conclusions:
- The no observed adverse effect level (NOAEL) for oral CK in Beagle dogs was determined to be 12 mg/kg.
- CK demonstrates a favorable safety profile at lower doses, with dose-dependent hepatotoxicity at higher levels.
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