Acute Oral Toxicity Testing of Thai Traditional Medicine “Ya-Kae-Lom-Utthang-Ka-Ma-Va-Ta” Formula in Sprague Dawley Rat

Abstract

Since herbal medicines are being used on large scale, the studies looking at the efficacy and safety profile of medicinal plants and herbal medicine formulary have increased especially in Thailand. Acute oral toxicity tests are the most commonly performed tests for toxicity assessment in herbal medicine. In this study, acute oral toxicity of Ya-Kae-Lom-Utthang-Ka-Ma-Va-Ta remedy (UKMVT) was determined by oral acute toxicity class method according to OECD guidelines No.423. Three female Sprague Dawley rats per step were used in the procedure. Before administering the sample, all animals fasted for approximately 16 hours. The starting dose was 2,000 mg/kg/body weight by gavage. After administration, animal survival, mortality and morbidity were confirmed. Clinical signs were observed at 30 minutes, 1, 2, 3, 4 hours, and every day for 14 days. The results showed that the animals in both steps with a dose 2,000 mg/kg body weight had normal clinical signs, with no mortality or morbidity, until termination. The acute oral toxicity of UKMVT is classified as category 5, or unclassified, according to the Globally Harmonized System (GHS) of classification and labeling of chemicals.  Therefore, The LD₅₀ was greater than 5,000 mg/kg body weight under the conditions of this study.