Assessment of the no-observed-adverse-effect level (NOAEL) of gallic acid in mice

• Published in: Food and chemical toxicology Vol. 39; no. 9; pp. 919 - 922
• Main Authors: Rajalakshmi, K, Devaraj, H, Niranjali Devaraj, S
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.09.2001; New York, NY Elsevier Science
• Subjects: Acute/subacute toxicity; Administration, Oral; Animals; Biological and medical sciences; Body Weight - drug effects; Female; Food toxicology; Gallic acid; Gallic Acid - administration & dosage; Gallic Acid - toxicity; Male; Medical sciences; Mice; No-Observed-Adverse-Effect Level; NOAEL; Organ Size - drug effects; Random Allocation; Tannins - metabolism; Toxicity Tests, Acute; Toxicology; NOAL; Mice; Acute/subacute toxicity; Gallic acid; NOAEL; Toxicity; Acute; Rodentia; Oral administration; Food additive; Harmlessness; Antioxidant; No observed effect level; Vertebrata; Mammalia; Mouse; Animal; Plant origin; Phenols; Subacute
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/S0278-6915(01)00022-9

Gallic acid is a naturally occurring plant phenol obtained by the hydrolysis of tannins and is known to show some pharmacological activities. The purpose of this paper is to establish the safety of gallic acid in mice. In this study, acute administration of gallic acid even at a dose as high as 5 g/kg body weight did not produce any signs of toxicity or mortality. In the subacute study, gallic acid at a dose of 1000 mg/kg body weight did not significantly alter the hematological parameters. Further, no appreciable change was noted in the various biochemical parameters such as SGOT and SGPT, as well as many serum constituents such as protein, cholesterol, urea and bilirubin. Therefore, from this study, it may be concluded that gallic acid is non-toxic up to a level of 5000 mg/kg body weight, when given orally. In addition, the subacute study indicated the absence of cumulative toxicity, as reflected by the non-significant alterations in the parameters investigated. The NOAEL was 5000 mg/kg body weight, the highest dose tested.