2020 Volume 17 Issue 1 Pages 1-17
Misatol GL is a neutralized processed food of ume extract which is a heated-concentrate of squeezed juice from green (immature) ume. Various biological effects of ume extract were reported, but its safety has not been evaluated. Hence, we evaluated safety of Misatol GL in SD rats by single dose and 90-day repeated oral administration. As a result of single oral dose, transient watery diarrhea was observed in Misatol GL 10 and 15 mL/kg groups, and this change was not observed in Misatol GL 5 mL/kg group. In 90-day repeated oral administration, a slight decrease in food consumption were observed in male Misatol GL 1.25 and 5 mL/kg/day groups and female Misatol GL 2.5 and 5 mL/kg/day groups. A slight vacuolation of forestomach were observed in male Misatol GL 1.25 and 5 mL/kg/day groups. These changes were considered to low toxicological significance. In addition, no changes caused by Misatol GL were observed in clinical signs, body weight, urinalysis, ophthalmology, blood test, necropsy and organ weight.