Safety assessment of ellagic acid, a food additive, in a subchronic toxicity study using F344 rats.
Ellagic acid is a phenolic acid compound, used as a food additive for its antioxidative properties. Because of its chemical characteristics, use is also to be expected in cosmetics. The present 90-day subchronic toxicity study was performed in F344 rats at dose levels of 0, 1.25, 2.5 and 5% in powdered basal diet, with actual doses of 9.4, 19.1, 39.1 g/kg b.w., respectively, in males, and 10.1, 20.1, 42.3 g/kg b.w. in females. No mortality or treatment-related clinical signs were observed throughout the experimental period. Body weight gain was significantly reduced from weeks 3 (5% group), 6 (2.5% group) and 7 (1.25% group) to the end of the experiment (except week 8 in the lowest group) in the treated females, the final body weights being decreased in the 5% (92.5%), 2.5% (94.2%) and 1.25% (94.8%) treated groups as compared to the control. Changes in MCV and serum AST, ALP, Ca, Cl and P were sporadically observed, but these were not considered to be treatment-related alterations. There were no obvious histopathological changes in any of the groups. The no-observed-effect level (NOEL) was estimated to be 5% (3011 mg/kg b.w./day) for males and the no-observed-adverse-effect level (NOAEL) and NOEL in females were estimated to be 5% (3254 mg/kg b.w./day) and <1.25% (778 mg/kg b.w./day), respectively.
D000818:Animals; D000975:Antioxidants / Q000633:toxicity*; D001774:Blood Chemical Analysis; D001835:Body Weight / Q000187:drug effects; D004610:Ellagic Acid / Q000633:toxicity*; D005247:Feeding Behavior / Q000187:drug effects; D005260:Female; D005503:Food Additives / Q000633:toxicity*; D006403:Hematologic Tests; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D051381:Rats; D011916:Rats, Inbred F344
D000975:Antioxidants; D005503:Food Additives; D004610:Ellagic Acid