Safety profile assessment of standardized root extract of Potentilla fulgens in Wistar rats: Acute and sub-acute dermal toxicity study

Abstract

Potentilla fulgens Wall (Rosaceae), a well-known medicinal plant native to Asian regions has a rich history of traditional use for treating skin, gastrointestinal tract, and various metabolic disorders. Research has addressed that the plant is applied topically to treat conditions such as wounds, ulcers, and other skin ailments. Surprisingly, no prior investigation has explored the dermal toxicity of this plant. Therefore, the study was set to conduct the acute and sub-acute toxicity assessments on the ethyl acetate (EAPF) and methanol (MEPF) extracts of P. fulgenson Wistar rats. In the acute dermal toxicity study, rats received a single dose and were monitored for 14 days, while in the sub-acute study; they received a daily dose for 28 days. 2,000 and 5,000 mg/kg were tested by applying them to the shaved dorsal skin. Throughout the experiments, changes in physical appearance, behavior, and histological alterations were monitored. The results unequivocally revealed no abnormal physical or physiological changes, behavioral deviations, or mortality in any of the rats in both acute and sub-acute dermal toxicity assessments. Furthermore, there were no statistically significant differences (nsp > 0.05) in body weight, kidney, liver, spleen weights, hematological parameters, or blood biochemistry values between the treatment and control groups. These findings were further substantiated by the normal macroscopic and microscopic characteristics of the rats’ skin, kidneys, liver, and spleen. In conclusion, our study affirms that the application of EAPF and MEPF to the skin does not induce acute or sub-acute skin irritation nor elicit systemic toxic responses in rats.