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Mutagenicity and safety evaluation of ethanolic extract of Prunus mume
Baiyi Lu1, Xiaoqin Wu, Yuejie Dong
1Dept. of Food Science and Nutrition, School of Biosystems Engineering and Food Science, Zhejiang Univ., Hangzhou 310029, Zhejiang Province, PR China.
Abstract:
The ethanolic extract of Prunus mume (EPM) is a novel polyphenol preparation derived from branches (with leaves) of Prunus mume, which could be used as a functional ingredient for antioxidant and antiobesity therapy. The purpose of this study was to evaluate the safety of EPM. An EPM was prepared and evaluated for oral acute and subacute toxicity in Sprague-Dawley rats, while its mutagenic potential was assessed by a reverse mutation test using Salmonella typhimurium, by a bone marrow cell micronucleus test using ICR mice, and by a sperm abnormality test using ICR mice. The results showed no acute lethal effects at the maximal tested EPM dose of 20 g/kg bw in either rats or mice, suggesting that EPM can be regarded as virtually nontoxic. Administration at levels of 0.84, 1.67, and 3.33 g/kg bw to rats for 30 d did not induce any significant hematological, clinical, chemical, or histopathological changes. No mutagenicity evidence was detected in any of the 3 mutagenic tests. The level of "no observed adverse effect" (NOAEL) for EPM was above 3.33 g/kg bw for the subacute toxicity study.
Insights
The ethanolic extract of Prunus mume (EPM) is safe for consumption, showing no toxicity or mutagenic effects in rodent studies. This novel polyphenol preparation is suitable for antioxidant and antiobesity functional ingredients.
Area of Science:
- Pharmacology
- Toxicology
- Natural Products
Background:
- Ethanolic extract of Prunus mume (EPM) is a novel polyphenol preparation.
- EPM is derived from branches (with leaves) of Prunus mume.
- EPM shows potential as a functional ingredient for antioxidant and antiobesity therapy.
Purpose of the Study:
- To evaluate the safety of EPM.
- To assess oral acute and subacute toxicity in Sprague-Dawley rats.
- To determine the mutagenic potential of EPM.
Main Methods:
- Oral acute and subacute toxicity tests in Sprague-Dawley rats.
- Reverse mutation test using Salmonella typhimurium.
- Bone marrow cell micronucleus test and sperm abnormality test in ICR mice.
Main Results:
- No acute lethal effects observed up to 20 g/kg bw in rats and mice, indicating EPM is virtually nontoxic.
- No significant hematological, clinical, chemical, or histopathological changes in rats after 30-day administration.
- No mutagenicity detected in Salmonella typhimurium, bone marrow, or sperm abnormality tests.
Conclusions:
- EPM is considered safe, with no observed adverse effects at doses up to 3.33 g/kg bw in subacute toxicity studies.
- EPM demonstrates a lack of mutagenic potential.
- EPM is a safe functional ingredient for antioxidant and antiobesity applications.
