Abstract
BackgroundUrsolic acid (UA) has been used in alternative medicine for decades, and there has been a great interest in its medicinal properties. Despite this increased interest, a detailed long-term toxicity study has not been performed. The objective of this study was to determine the long-term toxic effect of UA on clinical chemistry, haematology, coagulation, pathology/morphology, behaviour and motor skills in rats. MethodsA solution was made by dissolving UA in a mixture of 0.1% Tween 80 and 0.5% hydroxypropyl methylcellulose in Milli-Q Water. The control group received the vehicle, and the test groups received a dose up to 1000 mg/kg/day via oral gavage. The solution was administered to both male and female (Han-Wistar) rats for 90 consecutive days. ResultsUA did not cause any deaths, abnormal body weights or abnormal pathology at all test doses. In addition to that, no toxicological changes were observed in behaviour, neurotoxicity, coagulation, haematology or clinical chemistry that are related to the administration of UA. ConclusionThis study indicates that oral dosing of UA for 90 consecutive days does not lead to toxic effects at any of the doses. Therefore, the NOAEL for UA is likely to be higher than 1000 mg/kg/day.
Highlights
Ursolic acid (UA) is a pentacyclic triterpenoid that can be isolated from different types of plant leaves and fruit waxes [1]
No premature deaths were recorded during this study; all the data from each animal was included in all analysis unless indicated otherwise
Body weight and food consumption The body weight of the rats was measured on a daily basis
Summary
Ursolic acid (UA) is a pentacyclic triterpenoid that can be isolated from different types of plant leaves and fruit waxes [1]. Studies have shown that UA inhibits excitotoxicity [2] and oxidative stress [3] in the brain and this could indicate that UA may have protective properties against several brain diseases. Ursolic acid (UA) has been used in alternative medicine for decades, and there has been a great interest in its medicinal properties. Despite this increased interest, a detailed long-term toxicity study has not been performed. The objective of this study was to determine the long-term toxic effect of UA on clinical chemistry, haematology, coagulation, pathology/morphology, behaviour and motor skills in rats. Conclusion: This study indicates that oral dosing of UA for 90 consecutive days does not lead to toxic effects at any of the doses. The NOAEL for UA is likely to be higher than 1000 mg/kg/day
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