Objectives : Jeopgoltang (JGT) is a new Korean herbal medicine formulation that is used to treat bone fractures. Although JGT is frequently used in clinical practice, there is a lack of scientific evidence on its safety. This study aimed to evaluate the preclinical toxicity of JGT using a single oral dose toxicity test in Sprague-Dawley (SD) rats.
Methods : Five male and female rats per group were orally administered 1,250, 2,500, or 5,000 ㎎/㎏ of JGT after fasting for 12 h. Mortality and changes in clinical signs, body weight, and necropsy findings were monitored for 14 days according to the guidelines of the Korean Ministry of Food and Drug Safety and Organisation for Economic Co-operation and Development (OECD).
Results : No significant clinical signs or mortality were observed after a single administration of up to 5,000 ㎎/㎏. In addition, no significant necropsy findings related to JGT administration were observed.
Conclusions: In conclusion, these results suggest that approximate Lethal Dose (ALD) of JGT on SD rats is over 5,000 ㎎/㎏.