Safety assessment of heat-sterilized green tea catechin preparation: A 6-month repeat-dose study in rats

Food and Chemical Toxicology

Volumn 47, Issue 8, 2009, Pages 1760-1770

  Morita, Osamu ^a   Kirkpatrick, Jeannie B ^b   Tamaki, Yasushi ^a   Chengelis, Christopher P ^b   Beck, Melissa J ^b   Bruner, Richard H ^b  

^a KAO CORPORATION   (Japan)

^b WIL RESEARCH LABORATORIES   (United States)

Author keywords

Functional observational battery; Green tea catechins; Green tea extract; Long term effects; Rat; Toxicity

Indexed keywords

CATECHIN; CATECHIN GALLATE; EPICATECHIN; EPICATECHIN GALLATE; EPIGALLOCATECHIN; EPIGALLOCATECHIN GALLATE; GALLOCATECHIN; GALLOCATECHIN GALLATE; GREEN TEA EXTRACT; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL TISSUE; ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DRUG MEGADOSE; DRUG SAFETY; DRUG STRUCTURE; FEMALE; FLUID INTAKE; FOOD INTAKE; HEAT TREATMENT; HISTOPATHOLOGY; MALE; MOTOR ACTIVITY; NONHUMAN; RAT; SEX DIFFERENCE; TOXICITY TESTING; WEIGHT GAIN; WEIGHT REDUCTION;

ANIMALS; BEHAVIOR, ANIMAL; BLOOD CELL COUNT; BLOOD CHEMICAL ANALYSIS; BODY WEIGHT; CAFFEINE; CATECHIN; DOSE-RESPONSE RELATIONSHIP, DRUG; EATING; EYE; FEMALE; HOT TEMPERATURE; MALE; MOTOR ACTIVITY; RATS; RATS, SPRAGUE-DAWLEY; SEX CHARACTERISTICS; STEREOISOMERISM; STERILIZATION; SURVIVAL ANALYSIS; TEA; URINALYSIS;

RATTUS;

EID: 68649118070     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2009.04.033     Document Type: Article

References (46)

1. Bonkovsky H.L. Hepatotoxicity associated with supplements containing Chinese green tea (Camellia sinensis). Ann. Intern. Med. 144 (2006) 68-71
2. Chan P.T., Fong W.P., Cheung Y.L., Huang Y., Ho W.K.K., and Chen Z.Y. Jasmine green tea epicatechins are hypolipidemic in hamsters (Mwsocricetus auratus) fed a high fat diet. J. Nutr. 129 (1999) 1094-1101
3. Chaudhari P.N., and Hatwalne V.G. Effect of epicatechin on liver lipids of rats fed with choline deficient diet. Ind. J. Nutr. Dietet. 14 (1977) 136-139
4. Chen Z.-Y., Xhu Q.Y., Tsang D., and Huang Y. Degradation of green tea catechins in tea drinks. J. Agric. Food Chem. 49 (2001) 477-482
5. Chengelis C.P., Kirkpatrick J.B., Regan K.S., Radovsky A.E., Beck M.J., Morita O., Tamaki Y., and Suzuki H. 28-Day oral (gavage) toxicity studies of green tea catechins prepared for beverages in rats. Food Chem. Toxicol. 46 (2008) 978-989
6. Chow H.H., Cai Y., Hakim I.A., Crowell J.A., Shahi F., Brooks C.A., Dorr R.T., Hara Y., and Alberts D.S. Pharmacokinetics and safety of green tea polyphenols after multiple-dose administration of epigallocatechin gallate and polyphenon E in healthy individuals. Clin. Cancer Res. 9 (2003) 3312-3319
7. Dulloo A.G., Seydoux J., Girardier L., Chantre P., and Vandermander J. Green tea and thermogenesis: interactions between catechin-polyphenols, caffeine and sympathetic activity. Int. J. Obes. Relat. Metab. Disord. 24 2 (2000) 252-258
8. Dunnett C.W. New tables for multiple comparisons with a control. Biometrics 20 (1964) 482-491
9. Federico A., Tiso A., and Loguercio C. A case of hepatotoxicity caused by green tea. Free Radic. Biol. Med. 43 (2007) 474
10. Galati G., Lin A., Sultan A.M., and O'Brien P.J. Cellular and in vivo hepatotoxicity caused by green tea phenolic acids and catechins. Free Radic. Biol. Med. 40 (2006) 570-580
11. Hattori M., Kusumoto I.T., Namba T., Ishigami T., and Hara Y. Effect of tea polyphenols on glucan synthesis by glucosyltransferase from streptococcus mutans. Chem. Pharm. Bull. 38 (1990) 717-720
12. Henry J.P., and Stephen-Larson P. Reduction of chronic psychosocial hypertension in mice by decaffeinated tea. Hypertension 6 (1984) 437-444
13. Holtzman S.G. Complete, reversible, drug-specific tolerance to stimulation of locomotor activity by caffeine. Life Sci. 33 (1983) 779-787
14. Holtzman S.G., and Finn I.B. Tolerance to behavioral effects of caffeine in rats. Pharmacol. Biochem. Behav. 29 (1988) 411-418
15. Ikeda I. Multifunctional effects of green tea catechins on prevention of the metabolic syndrome. Asia Pac. J. Clin. Nutr. 17 S1 (2008) 273-274
16. Ikeda I., Imasato Y., Sasaki E., Nakayama M., Nagao H., Takeo T., Yayabe F., and Sugano M. Tea catechins decrease micellar solubility and intestinal absorption of cholesterol in rats. Biochim. Biophys. Acta 1127 (1992) 141-146
17. Isbrucker R.A., Edwards J.A., Wolz E., Davidovich A., and Bausch J. Safety studies on epigallocatechin gallate (EGCG) preparations. Part 2: dermal, acute and short-term toxicity studies. Food Chem. Toxicol. 44 (2006) 636-650
18. Ishigaki A., Tonooka F., Matsumoto N., and Hara Y. Suppression of the accumulation of body and liver fat by tea catechin. Proc. Int. Sympos. Tea Sci. 30 (1991) 9-313
19. Kadowaki M., Ootani E., Sugihara N., and Furuno K. Inhibitory effects of catechin gallates on o-methyltranslation of protocatechuic acid in rat liver cytosolic preparations and cultured hepatocytes. Biol. Pharm. Bull. 28 (2005) 1509-1513
20. Kakegawa H., Mitsumoto H., Endo K., Sato T., Nonaka G., and Nishioka I. Inhibitory effects of tannins on hyaluronidase activation and on the degranulation from rat mesentery mast cells. Chem. Pharm. Bull. 33 (1985) 5079-5082
21. Katiyar S.K., and Mukhtar H. Tea in chemoprevention of cancer: epidemiologic and experimental studies (Review). Int. J. Oncol. 8 (1996) 221-238
22. Kim E.S., Liang Y.R., Jin J., Sun Q.S., Lu J.L., Du Y.Y., and Lin C. Impact of heating on chemical compositions of green tea liquor. Food Chem. 103 (2007) 1263-1267
23. Lambert J.D., Sang S., and Yang C.S. Possible controversy over dietary polyphenols: benefits vs risks. Chem. Res. Toxicol. 20 (2007) 583-585
24. Matsumoto N., Ishigaki F., Ishigaki A., Iwashima H., and Hara Y. Reduction of blood glucose levels by tea catechin. Biosci. Biotech. Biochem. 57 (1993) 525-527
25. Murase T., Nagasawa A., Suzuki J., Hase T., and Tokimitsu I. Beneficial effects of tea catechins on diet-induced obesity: stimulation of lipid catabolism in the liver. Int. J. Obesity 26 (2002) 1459-1464
26. Nagai M., Conney A.H., and Zhu B.T. Strong inhibitory effects of common tea catechins and bioflavonoids on the O-methylation of catechol estrogens catalyzed by human liver cytosolic catechol-O-methyltransferase. Drug Metab. Dispos. 32 (2004) 497-504
27. Nagao T., Meguro S., Soga S., Otsuka S., Tomonobu K., Fumoto S., Chikama A., Mori K., Yuzawa M., Watanabe H., Hase T., Tanaka Y., Tokimitsu I., Shimasaki H., and Itakura H. Tea catechins suppress accumulation of body fat in humans. J. Oleo Sci. 50 (2001) 717-728
28. Nagao T., Komine Y., Soga S., Meguro S., Hase T., Tanaka Y., and Tokimitsu I. Ingestion of a tea rich in catechins leads to a reduction in body fat and malondialdehyde-modified LDL in men. Am. J. Clin. Nutr. 81 (2005) 122-129
29. Nagao T., Hase T., and Tokimitsu I. A green tea extract high in catechins reduces body fat and cardiovascular risks in humans. Obesity 15 6 (2007) 1473-1483
30. Nakayama M., Suzuki K., Toda M., Okubo S., Hara Y., and Shimamura T. Inhibition of the infectivity of influenza virus by tea polyphenols. Antiviral Res. 21 (1993) 289-299
31. National Research Council, 1996. Guide for the care and use of laboratory animals. Institute of Laboratory Animal Resources, Commission on Life Sciences. National Academy Press, Washington, DC, p. 125.
32. Osaki N., Harada U., Watanabe H., Onizawa K., Yamaguchi T., Tokimitsu I., Shimasaki H., and Itakura H. Effect of tea catechins on energy metabolism in rats. J. Oleo Sci. 50 (2001) 677-682
33. Oz H.S., and Chen T.S. Green-tea polyphenols downregulate cyclooxygenase and bcl-2 activity in acetaminophen-induced hepatotoxicity (2008), Dig. Dis. Sci. (epub ahead of Print)
34. Oz H.S., McClain C.J., Nagasawa H.T., Ray M.B., de Villiers W.J., and Chen T.S. Diverse antioxidants protect against acetaminophen hepatotoxicity. J. Biochem. Mol. Toxicol. 18 (2004) 361-368
35. Raederstorff D.G., Schlachter M.F., Elste V., and Weber P. Effect of EGCG on lipid absorption and plasma lipid levels in rats. J. Nutr. Biochem. 14 (2003) 326-332
36. Sakamoto Y., Mikuriya H., Tayama K., Takahashi H., Nagasawa A., Yano N., Yuzawa K., Ogata A., and Aoki N. Goitrogenic effects of green tea extract catechins by dietary administration in rats. Arch. Toxicol. 75 (2001) 591-596
37. Sarma D.N., Barrett M.L., Chavez M.L., Gardiner P., Ko R., Mahady G.B., Marles R.J., Pellicore L.S., Giancaspro G.I., and Low Dog T. Safety of green tea extracts: a systematic review by the US Pharmacopeia. Drug Saf. 31 (2008) 469-484
38. Schmidt M., Schmitz H.J., Baumgart A., Guedon D., Netsch M.I., Kreuter M.H., Schmidlin C.B., and Schrenk D. Toxicity of green tea extracts and their constituents in rat hepatocytes in primary culture. Food Chem. Toxicol. 43 (2005) 307-314
39. Seto R., Nakamura H., Nanjo F., and Hara Y. Preparation of epimers of tea catechins by heat treatment. Biosci. Biotech. Biochem. 61 (1997) 1434-1439
40. Snedecor G.W., and Cochran W.G. One Way Classifications; Analysis of Variance. In Statistical Methods. seventh ed. (1980), The Iowa State University Press, Ames, IA pp. 215-237
41. Steel R.G.D., and Torrie J.H. Principles and Procedures of Statistics, A Biometrical Approach. second ed. (1980), McGraw-Hill Book Company, New York, NY pp. 504-506
42. Takami S., Imai T., Hasumura M., Cho Y.M., Onose J., and Hirose M. Evaluation of toxicity of green tea catechins with 90-day dietary administration to F344 rats. Food Chem. Toxicol. 46 (2008) 2224-2229
43. Uchida S., Ozaki M., Suzuki K., and Shikita M. Radioprotective effects of (-)-epigallocatechine 3-o-gallate (green-tea tannin) in mice. Life Sci. 50 (1992) 147-152
44. Yang T.T., and Koo M.W. Chinese green tea lowers cholesterol level through an increase in fecal lipid excretion. Life Sci. 66 (2000) 411-423
45. Yokozawa T., Nakagawa T., and Kitani K. Antioxidative activity of green tea polyphenol in cholesterol-fed rats. J. Agric. Food Chem. 50 (2002) 3549-3552
46. Yoshino K., Hara Y., Sano M., and Tomita I. Antioxidative effects of black tea theaflavins and thearubigin on lipid peroxidation of rat liver homogenates induced by tert-butyl hydroperoxide. Biol. Pharm. Bull. 17 (1994) 146-149