Toxicological evaluation of Gumiganghwaltang aqueous extract in Crl:CD (SD) rats: 13 weeks oral gavage studies.

Gumiganghwaltang is a traditional oriental herbal medicine that has been commonly used to treat colds and inflammatory diseases. Aqueous extract of Gumiganghwaltang (GMGHT) was administrated daily by oral gavage to male and female rats for 13 weeks. A dose of 2000 mg/kg/day was selected as a maximum, and doses of 1000 and 500 mg/kg/day were determined as medium and low doses, respectively. No treatment-related clinical signs or mortality were observed in the treatment group. We observed no clear treatment-related effects with regard to body weight, food consumption, ophthalmology, hematology, or urinalysis data. The serum biochemistry values for sodium and chloride in the treated male and female groups (1000 mg/kg/day) were lower than in those treated with the vehicle control. However, these changes lacked dose dependence, and no abnormalities were found in corresponding pathological findings. Our results indicated that the no-observed-adverse-effect-level (NOAEL) for GMGHT was determined to be a dietary dose of over 2000 mg/kg/day for both sexes under the present experimental conditions.