Safety Assessment of Hydro-Ethanolic Extract of Falcaria vulgaris in Wistar Rats: Acute and Subchronic Toxicities

Background: Falcaria vulgaris is a medicinal plant with culinary uses and widespread therapeutic applications. Despite already proven as a very promising dietary supplement, its safety and possible effects on the human body are yet to define. This study was designed to investigate the acute and subchronic toxic effects of hydroethanolic F. vulgaris in male and female Wistar rats. 
Experimental: To evaluate the safety of a hydroethanolic extract of F. vulgaris, acute and subchronic toxicity in Wistar rats treated with extract was investigated. For investigation of acute toxicity of F. vulgaris, both genders of rats were treated for 45 days with a single dose of the extract (4000 mg/ kg) via gavage. Also for sub-chronic testing, the extract was administrated orally at the doses of 150, 300, and 450 mg/kg for 45 days. At the end of the study, the animals were sacrificed and the hematological, biochemical, and histopathological parameters were assayed. 
Results: After a single oral administration of F. vulgaris (4000 mg/kg), no mortality was observed in both control and groups in either sex. Also, histopathological inspection of vital organs and tissues revealed no obvious alteration in these organs. The obtained results showed a significant reduction in the weight of heart and liver in male rats that received the highest dose of the extract. The level of red blood cell distribution width (dose of 450 mg/kg) from the hematological parameters and the level of serum creatinine (dose of 150 and 450 mg/kg) from the biochemical parameters increased significantly in male rats. On the contrary, during treatment the concentration of all examined minerals remained unchanged. Histopathological inspection indicated that liver, kidney, and testis were found to be affected by subchronic exposure to F. vulgaris extract. 
Conclusion: The results of the acute study revealed that F. vulgaris may be nontoxic even at doses less than 4000 mg/kg body weight. However, the result of subchronic study confirmed the liver dysfunctions in Wistar rats and also suggested the significant effect of F. vulgaris on testicular tissue, which may cause serious male infertility. The ability to impair male fertility by such a medicinal plant has not been reported yet. It can be concluded that the no observed adverse effect level (NOAEL) of F. vulgaris are 150 and 450 mg/kg for male and female rats, respectively.