Acute Oral Toxicity Test Of Brazilin (From Caesalpinia Sappan l) On Female Wistar Rats

Abstract

The development of novel anticancer therapeutics from natural sources requires comprehensive safety evaluation. The main bioactive component of sappan wood (Caesalpinia sappan L.), brazilin, has shown encouraging anticancer qualities, such as inducing apoptosis and inhibiting the multiplication of malignant cells, and so merits toxicological evaluation for clinical development. The purpose of this study is to assess the acute oral toxicity of brazilin as a potential anticancer agent and determine the LD₅₀ values and target organ effects in female Wistar rats to establish safety parameters for anticancer drug development. The OECD 425 Up and Down Procedure was employed to evaluate acute oral toxicity. Female Wistar rats were administered oral dosages of 2000 mg/kg of body weight. Clinical symptoms, mortality rates, body weight changes, and histological alteration in the stomach, liver, kidneys, and spleen were observed during a period of 14 days. The data analysis using AOT425StatPgm software. No mortality or acute toxicity symptoms were observed at a dosage of 2000 mg/kg body weight, showing that brazilin is non-toxic with an LD₅₀ exceeding 2000 mg/kg. Histopathological examination indicated mild, reversible alterations, such as gastric mucosal erosion and localized hepatic hydropic degeneration, without significant organ damage. The findings suggest adequate safety margins for the development of anticancer therapies. These findings provide acceptable safety margins for the development of anticancer therapies. Brazilin exhibits an excellent acute toxicity profile appropriate for anticancer drug development, with an LD₅₀ approaching 2000 mg/kg body weight. The identified minor histological alterations offer significant safety implications for continuous dosage protocols in cancer therapy. Conclusions encourage the progression of brazilin to efficacy studies in cancer models and the assessment of chronic toxicity for clinical development.