Toxicological evaluation of Yulangsan polysaccharide in Wistar rats: A 26-week oral gavage study

•The LD50 of YLSP in mice based on the acute oral toxicity study is greater than 24 g/kg body weight.•No mortality and toxicologically relevant changes were observed in the toxicity study.•The NOAEL of YLSP in rats is greater than 2.4 g/kg.

Although numerous studies have proven the medicinal values of Yulangsan polysaccharide (YLSP), the toxicity of this active ingredient is unknown. In the acute toxicity study, a single oral administration of 24 g/kg YLSP caused neither toxicological symptoms nor mortality, and the LD50 was estimated >24 g/kg. In the chronic toxicity study, we administered doses of 0, 0.6, 1.2 and 2.4 g/kg YLSP in rats by oral gavage for 26 weeks followed by a 3-week recovery period. There was no mortality or remarkable clinical signs observed during this 26-week study. Additionally, there were no toxic differences in the following parameters: body weight, food consumption, hematology, clinical biochemistry, organ weight, and macroscopic findings. There were no adverse effects on histopathology observed in males or female rats treated with YLSP. Based on the results, the no-observed-adverse-effect-level of YLSP in rats is greater than 2.4 g/kg when administered orally for 26 consecutive weeks.

Graphical abstractFigure optionsDownload full-size imageDownload as PowerPoint slide