Acute and Repeated Toxicological Study of Anti-Inflammatory Herbal Formula, Yeosinsan, in Rats

Abstract

Yeosinsan, an herbal formula composed of roots of Paeonia lactiflora and tubers of Cyperus rotundus, was reported as a possible anti-inflammatory and pro-fertility drug. However, the safety of Yeosinsan has not yet been previously investigated. The possible acute and chronic oral toxicity of Yeosinsan was estimated using female and male Sprague Dawley rats. During the administration period, rats were monitored for mortality, body weight changes, food intake, clinical signs, and gross findings. Hematological analysis, serum biochemistry analysis, urinalysis, organ weight measurement, and histopathological examination were also conducted after sacrifice. Acute and chronic oral administration of Yeosinsan did not result in any signs of toxicity in the animals during the observation period. However, in the histopathological examination, several significant changes were observed in the stomach and spleen. In the high-dose group, extramedullary hematopoiesis and increased pigmentation in the spleen and squamous cell hyperplasia in the forestomach were observed. In conclusion, the no observed adverse effect level (NOAEL) of the test material, Yeosinsan, was estimated at 1000 mg∙kg−1∙d−1 for both male and female rats. Therefore, our data suggest that Yeosinsan might be safe to use for treating female infertility.