Repeated-dose 26-week oral toxicity study of ginsenoside compound K in Beagle dogs.
J Ethnopharmacol
; 248: 112323, 2020 Feb 10.
Article
in En
| MEDLINE
| ID: mdl-31639487
ABSTRACT
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 36â¯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 36â¯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 12â¯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 12â¯mg/kg.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Ginsenosides
/
Chemical and Drug Induced Liver Injury
/
Liver
Type of study:
Etiology_studies
/
Risk_factors_studies
Limits:
Animals
Language:
En
Journal:
J Ethnopharmacol
Year:
2020
Document type:
Article