


Safety studies on epigallocatechin gallate (EGCG) preparations.
Part 1: Genotoxicity.
Public interest in green tea has grown recently due to the potential health benefits from
its consumption. Epigallocatechin gallate (EGCG), a principal polyphenolic component
of green tea, is considered key to these healthful qualities. Although numerous studies
have evaluated the anti-cancer effects of green tea and EGCG, few have examined the
safety of EGCG consumption. The genotoxic potential of a concentrated EGCG
preparation was tested in Salmonella and L5178Y tk(+/-) mouse lymphoma cell assays
to further define the safety of Teavigotrade mark, a high-concentration EGCG extract
of Camellia sinensis leaves produced by the same novel method. No mutagenic activity
was detected in the bacterial system; however, a clastogenic 'trend' from the formation
of hydrogen peroxide was noted in the murine cells. The oral administration of 500,
1000, or 2000mg EGCG/kg to mice did not induce micronuclei formation in bone
marrow cells. Similarly, administering 400, 800, or 1200mg EGCG/kg/day in their diet
for 10days did not induce bone marrow cell micronuclei and produced plasma EGCG
concentrations comparable to those reported in human studies. The intravenous
injection of 10, 25 and 50mg EGCG/kg/day to rats resulted in much higher plasma
concentrations and demonstrated an absence of genotoxic effects. From these studies,
it is concluded that Teavigotrade mark (EGCG) is not genotoxic.
Isbrucker RA, Bausch J, Edwards JA, Wolz E.
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