Misatol GLのラットを用いた単回経口投与毒性試験及び90日間経口投与毒性試験  [in Japanese] Single dose and 90-day repeated dose oral toxicity studies of a processed ume extract food Misatol in rats  [in Japanese]

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<p>Misatol GLをSD系ラット雌雄に単回及び90日間反復経口投与し,安全性について評価した.単回経口投与において,Misatol GL原液を5, 10及び15 mL/kgの用量で単回経口投与した結果,5 mL/kgでは異常は認められず,10及び15 mL/kgで一過性の水様性下痢が認められた.90日間の反復経口投与において,Misatol GLを1.25, 2.5及び5 mL/kg/dayの用量で投与した結果,雄のMisatol GL 1.25 mL/kg/day投与群及び5 mL/kg/day投与群及び雌のMisatol GL 2.5 mL/kg/day投与群及び5 mL/kg/day投与群において,軽微な摂餌量の低下が,雄のMisatol GL 1.25 mL/kg/day投与群及び5 mL/kg/day投与群において,軽微な前胃の空胞化が認められたが,いずれも毒性学的な意義は低いと考えられた.一般状態,体重,尿検査,眼科学的検査,血液検査,剖検及び器官重量において,Misatol GLに起因する変化は認められなかった.したがって,Misatol GLの安全性は高いと考えられた.</p>

<p>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.</p>


  • Journal of Nutritional Food

    Journal of Nutritional Food 17(1), 1-17, 2020

    Japan Health and Nutrition Food Association


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