Subchronic toxicity of propyl-gallate

A subchronic toxicity experiment with propyl gallate in SPF-derived Wistar RIVM:TOX rats was performed. Groups of 10 female and 10 male rats were fed a semisynthetic diet containing 0, 490, 1910 and 7455 mg propyl gallate /kg feed. Body weight gain was recorded weekly and food-intake twice weekly. Other parameters comprised haematology, biochemical determinations in urine, serum and liver and complete histopathological examinations. Adverse effects of propyl gallate observed in the high dose group were effects on the haemopoeitic system reflected in the haematological parameters and the morphological changes in the spleen. The other effects observed comprised decreased incidence of the nephrocalcinosis in female rats, the increased activity of EROD in the high dose group and increased activity of the conjugating enzymes; glucorynyl-transferase and glutathion-s-transferase, in the mid and high dose group of propyl gallate. The effects on the nephrocalcinosis and on the conjugating enzymes may be considered as not adverse. The no observed adverse effect level (NOAEL) is 1910 mg propyl gallate /kg feed corresponding with 135 mg propyl gallate /kg body weight.