The safety of Osmanthus fragrans ethanol extract treatment in BALB/c mice

  • Authors

    • Chien-Ya Hung Department of Food Nutrition Chung Hwa University of Medical Technology
    • Chih-Hung Lin Department of Optometry, Chung Hwa University of Medical Technology, Tainan City, Taiwan.
    • Kuo-Yu Li Department of Food Nutrition, Chung Hwa University of Medical Technology, Tainan City, Taiwan
    • Tsung-Jen Hung Department of Graduate Institute of Biomedical Science, Chung Hwa University of Medical Technology, Tainan 71703, Taiwan.
    • Fu-Long Huang Graduate Institute of Food Science, National Chiayi University, Chiayi City, Taiwan
    2013-12-06
    https://doi.org/10.14419/ijpt.v2i1.1426
  • Background: Osmanthus fragrans flower, recently certificated as a new natural antioxidant, has been used in various foods. We performed an acute and subacute toxicological test for evaluating the safety and toxicity of 75 % ethanol extraction of Osmanthus fragrans (OFEE).

    Method: In the acute toxicity study, a single dose of 5 g/kg and 10 g/kg of the extract was administered orally to six mice. General behaviour, mortality and toxic symptoms were determined daily for 14 days. For the subacute toxicity, two groups of 12 mice received 0.9% normal saline (control) and 1 g/kg of the extract daily for 28 consecutive days by oral gavage. The animals were observed daily for abnormal clinical signs and death. Body weight, haematological and biochemical parameters of blood as well as kidney, liver, lung and spleen tissues histology were evaluated.

    Results: The total phenolic contents in OFEE were 371.71 ± 12.35 mg GAE/g extracts and total flavonoid contents were 47.23 ± 5.36 mg QE/g extract. OFEE did not cause any mortality or morbidity. Maximum tolerated dose (MTD) was 10 g/kg body weight in our BALB/c mice, which can be regarded as virtually non-toxic. Administration of OFEE at dose 1 g/kg/day for 28-day did not cause changed in hematological, biochemical assay, and histopathological conditions change, suggesting a no-observed-adverse-effect level (NOVEL) of 1 g/kg/day.

    Conclusion: We found no evidence of adverse effects in our laboratory test and pathological studies. 75 % ethanol extraction may safely be used in the research of Osmanthus fragrans in animal and probably human studies.

     

  • References

    1. Huxley A (1992) Ed. New RHS Dictionary of Gardening.
    2. Cochinch. Osmanthus Loureiro. Fl. Flora of China. (1996) 15, 286–292.
    3. Kikuchi M (1984) Studies on the constituents of Osmanthus species. I. The components of the leaves of Osmanthus fragrans Lour. Var. aurantiacus Makino. 1. Yakugaku Zasshi 104, 535–539.
    4. Lee HH, Lin CT & Yang LL (2007) Neuroprotection and free radical scavenging effects of Osmanthus fragrans. Journal of Bi-omedical Science 14, 819–827.
    5. Wang H, Gan D, Zhang X & Pan Y (2010) Antioxidant capacity of the extracts from pulp of Osmanthus fragrans and its components. LWT - Food Science and Technology 43, 319–325.
    6. Hung CH, Tsai YC & Li KY(2012) Phenolic Antioxidants Isolated from the Flowers of Osmanthus fragrans. Molecules 17, 10724–10737.
    7. Lee DG, Lee SM, Bang MH, Park HJ, Lee TH, Kim YH, Kim JY & Baek NI (2011) Lignans from the flowers of Osmanthus fragrans var. aurantiacus and their inhibition effect on NO production. Archlive of Pharmacal Research 34, 2029–2035.
    8. Hung CY, Yang YH, Tsai YC, Hung MY & Lin CH (2012) The effects of Osmanthus fragrans flower extract on maternally deprived rats in early life. Life Science Journal 9, 3173–3178.
    9. Tu, CH, Sun, YM, Tsai YC, Hung TJ, Chu HF & Hung CY (2014) Osmanthus fragrans ex-tracts for preventing noise induced hearing loss in brewery workers: a randomized, double-blind, controlled study. Journal of Alternative and Complementary Medicine, in press.
    10. Hung CY & Ye YL (2011) Extracted method of anti-asthmatic substances from Osmanthus fragrans. Taiwan patent number: I341205. May, 1.
    11. Li KY, Tsai YC & Hung CY (2013) Effect of Osmanthus Fragrans flower beverage on antioxidant activity in healthy individuals. Taiwanese Journal of Agricultural Chemistry and Food Science 51, 7-16.
    12. Guideline assessment for food safety of health foods (1999) Department of Health (DOH). Taipei, Taiwan, R.O.C.
    13. Mehta AK, Arora N, Gaur SN & Singh BP (2009) Acute toxicity assessment of choline by inhalation, intraperitoneal and oral routes in Balb/c mice. Regulatory Toxicology and Pharmacology 54, 282–286.
    14. Cheng YW, Lou HY, Lee SS, Liao JW, Chengi, HW, Li CH, Liao PL & Kang JJ (2010) Safety assessment of musk substitute from nu-tria of yocastor Coypus in mice. Journal of Food and Drug Analysis 18, 380–390.
    15. Freireich EJ, Gehan EA, Rall DP, Schmidt LH & Skipper HE (1966) Quantitative comparison of toxicity of anticancer agents in mouse, rat, hamster, dog, monkey, and man. Cancer Chemotherapy Reports 50, 219–244.
    16. Schein PS, Davis RD, Carter S, Newman J, Schein DR & Rall DP (1970) The evaluation of anticancer drugs in dogs and monkeys for the prediction of qualitative toxicities in man. Clinical Pharmacology and Therapeutics 11, 3–40.
    17. Reagan-Shaw S, Nihal M & Ahmad N (2007) Dose translation from animal to human studies revisited. Faseb Journal 22, 659–666.
    18. Estimating the safe starting dose in clinical trials for therapeutics in adult healthy volunteers (2002) Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, USA.
    19. Yen GC & Hung CY (2000) Effects of alkaline and heat treatment on antioxidative activity and total phenolics of extracts from Hsian-tsao (Mesona procumbens Hemsl.). Food Research International 33, 487–492.
    20. Woisky RG & Salatino A (1998) Analysis of propolis: some parameters and procedures for chemical quality control. Journal of Apicultural Research 37, 99–105.
    21. Chang CC, Yang MH, Wen HM & Chern JC (2002) Estimation of total flavonoid content in propolis by two complementary colorimetric methods. Journal of food and drug analysis 10, 178–182.
    22. Shimada K, Fujikawa K, Yahara K & Nakamura T(1992) Antioxidative properties of xanthan on the autoxidation of soybean oil in cycodextrin emulsion. Journal of Agricultural and Food Chemistry 40, 945.
    23. Chung KY, Lee SJ, Chung SM, Lee MY, Bae ON & Chung JH (2005) Generation of free radical by interaction of iron with thiols in human plasma and its possible significance. Thrombosis Research 116, 157-164.
  • Downloads

  • How to Cite

    Hung, C.-Y., Lin, C.-H., Li, K.-Y., Hung, T.-J., & Huang, F.-L. (2013). The safety of Osmanthus fragrans ethanol extract treatment in BALB/c mice. International Journal of Pharmacology and Toxicology, 2(1), 8-12. https://doi.org/10.14419/ijpt.v2i1.1426