A 14-day repeated dose oral toxicity assessment of the aqueous-ethanolic extract of Schouwia purpurea in female Wistar albino mice

Abstract

Schouwia purpurea (Family: Brassicaceae) S. purpurea is a wild medicinal plant traditionally used for treating gastrointestinal, inflammatory, and infectious disorders in arid regions of North Africa. Despite its ethnomedicinal importance, little is known about its systemic safety profile. This study aimed to evaluate the 14-day repeated dose oral toxicity of the aqueous-ethanolic extract of (SPE) S. purpurea in female albino Wistar mice. Thirty mice were randomly assigned into five groups (n = 6): control (distilled water), and extract-treated groups receiving 200, 500, 1000, and 2000 mg/kg of S. purpurea via oral gavage for 14 consecutive days. Animals were observed daily for mortality, behavioral changes, and clinical signs of toxicity. Blood samples were collected for biochemical analysis of liver and kidney function markers alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea, and creatinine. No deaths were recorded in any group. Groups receiving 200 and 500 mg/kg showed no significant changes in biochemical markers. However, a significant dose-dependent elevation in ALT, AST, urea, and creatinine was observed at 1000 and 2000 mg/kg. Additionally, mice in the 2000 mg/kg group exhibited mild lethargy and transient convulsions during the second week, suggesting potential neurotoxic effects, without mortality. These results indicate that the SPE is biochemically and clinically safe at doses up to 500 mg/kg. However, due to the presence of mild histopathological alterations in the liver and kidneys at 500 mg/kg, the dose of 200 mg/kg is established as the no-observed-adverse-effect level (NOAEL), while 500 mg/kg is identified as the lowest-observed-adverse-effect level (LOAEL). Higher doses of SPE may induce dose-dependent hepatic, renal, and neurobehavioral stress.