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EC number: 205-749-9
CAS number: 149-91-7
Repeated dose toxicity tests have been peformed by oral route in 2
publications for 28 and 90 days with determination of
Although the effects of repeated administration of GA on the induction
of liver enzymes are not known, induction of O-methyltransferase and
some other enzymes may be responsible for the dose-dependent increase of
liver weight and centrilobular liver cell hypertrophy in the present
Subchronic toxicity of gallic acid (GA) was investigated in F344 rats by
feeding diet containing 0, 0.2, 0.6, 1.7 and 5% GA for 13 weeks.
Each group consisted of 10 rats of each sex. Toxicological parameters
included clinical signs, body weight, food consumption, hematology,
blood biochemistry, organ weights and histopathological assessment.
Body weight gain in the 5% GA-treated animals of both sexes from week 1
to the end of the experiment was significantly lower than that of the
untreated controls. Toxic effects following administration of 0.6% or
more in males and 5% in females included reduction of hemoglobin
concentration, hematocrit and red blood cell counts and increase in
reticulocytes. Histopathologically, extramedullary hematopoiesis,
hemosiderin deposition and congestion appeared in the spleens of 5 %
GA-treated animals, suggesting developement of hemolytic anemia. In
addition, centrilobular liver cell hypertrophy, reflected in increase in
liver weight, was observed in animals of both sexes from 1.7%. In the
kidney, Berlin blue-negative brown pigment deposition in the proximal
tuber epithelium was observed at 5% GA. However, the severity of these
pathological change was weak.
Based on the present toxicology data, 0.2% was determined to be a
no-observed-adverse-effect level (NOAEL) in rats.
This level was translated into 119 and 128 mg/kg/day, respectively for
male and female rats.
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