Preclinical Safety Assessment of an Ayurvedic Dentifrice: Acute and 28-Day Oral Toxicity Studies in Wistar Albino Rats.

Abstract

Background: Herbal formulations with antimicrobial and anti-inflammatory properties are commonly used in traditional medicine for oral hygiene. Despite growing popularity, little or no research exists on the safety profile of these products to confirm their long-term safety. An ayurvedic dentifrice formulation was analyzed in Wistar albino rats for acute and subacute oral toxicity, with emphasis on the toxic effects of the product on physiological, hematological, biochemical, and histopathological parameters. Methods: Wistar rats (n = 6) were administered a single dose of the test formulation above 2000 mg/kg body weight and were kept on a 14-day observation period for acute toxicity. Subacute toxicity was induced by daily oral administration of 300, 600, and 1000 mg/kg of the test formulation to male (n = 30) and female (n = 30) rats for 28 days. A 14-day recovery period in the high-dose group was then carried out. Clinical signs, including mortality, food and water intake, body weight, hematological and biochemical parameters, vital organ weights, and histopathological alterations, were assessed. Results: Acute and subacute toxicity studies did not reveal any mortality or significant clinical signs. At 2000 mg/kg body weight, the hepatic changes were minor and reversible. The no-observed-adverse-effect level (NOAEL) was determined to be 1000 mg/kg body weight, as there were no significant changes in biochemical, hematological, and histopathological parameters until this dose. Conclusions: In Wistar albino rats, the tested Ayurvedic dentifrice formulation tapered with quiescent toxicity can be considered safe for oral use. Long-term studies in the form of clinical trials are recommended for human use.