Safety assessment of yerba mate (Ilex paraguariensis) dried extract: results of acute and 90 days subchronic toxicity studies in rats and rabbits.

Acute toxicity of yerba mate dried extract (YMDE) was investigated in Wistar rats (6/sex/group) from single dose of 2g/kg body weight by intragastric administration and 14days monitoring. Subchronic toxicity was investigated in Wistar rats, by intragastric administration (10/sex/group), and in New Zealand rabbits by oral administration (3/sex/group) of 2g/kg body weight for 12weeks. Toxicological parameters included clinical signs, body weight, water, and food consumption, hematological and serum parameters, and histopathological assessment. Acute YMDE administration showed no effects on survival, clinical observations, macroscopic examination of organs, body weight or food, and water consumption. Sub-chronic administration of YMDE did not change behavior, body weight, and histopatological assessment of stomach, kidney, liver, and small gut. Moreover, most of biochemical and hematological parameters remained unchanged. In summary, the results of our preclinical toxicological investigation are indicative that the YMDE is well tolerated for both single and chronic administration.