Acute Oral Toxicity Study And Safety Assesment Of An Herbal Formulation Containing Nigella Sativa, Aegle Marmelos, Crassocephalum Crepidioides, And Spondias Pinnata In Mice

Although polyherbal compositions are frequently employed in traditional medicine, further pharmacological or clinical development must wait until their safety has been scientifically confirmed. Important first data on systemic tolerance, target-organ safety, and median lethal dosage (LD₅₀) are provided by acute oral toxicity studies. As a combination herbal preparation, the polyherbal formulation SANCEB—which contains Spondias pinnata, Aegle marmelos, Nigella sativa, and Crassocephalum crepidioides—necessitated a thorough safety assessment. Assessing SANCEB's acute oral toxicity, systemic safety, and LD₅₀ classification in mice in compliance with OECD Test Guideline 423 (Acute Toxic Class Method) was the goal of the current investigation. Mice were given 400 and 2000 mg/kg body weight of SANCEB orally as a single dose, and the acute oral toxicity was assessed. Throughout the trial period, the animals were monitored for behavioral changes, clinical indications of toxicity, and mortality. Relative organ weights were assessed after body weight, food, and water intake were tracked. To find any structural changes connected to treatment, main organs such as the liver, heart, lungs, brain, and kidneys were examined histopathologically. At any dose level, no mortality or clinical or behavioral problems associated with therapy were noted. There was no immediate systemic toxicity, as evidenced by the body weight progression and food and water consumption remaining similar to the control group. Histopathological analysis indicated maintained tissue architecture in all studied organs without indications of inflammation, necrosis, or degenerative alterations, and relative organ weights did not exhibit any notable changes. The fact that there was no death at the 2000 mg/kg body weight limit dose suggested that SANCEB's LD₅₀ was higher than 2000 mg/kg, placing it in OECD/GHS Category 5 (unclassified) for acute oral toxicity. The study shows that the polyherbal formulation SANCEB has a broad margin of safety, low acute systemic toxicity, and is safe and well tolerated after acute oral administration. These results lend credence to additional sub-acute and chronic toxicity investigations in order to fully determine the formulation's longterm safety profile.