Acute Oral Toxicity Evaluation of Vangadi Yoga, a Classical Herbo-Metallic Formulation in Wistar Albino Rats Conducted According to OECD Test Guideline 423.
DOI:
https://doi.org/10.70066/jahm.v14i8.2869Keywords:
Acute toxicity, Bhasma, Vangadi Yoga, Histopathology, OECD test guideline 423Abstract
Background:
Vanga Bhasma, is known to be effective in disorders related to Shukra is used either singularly or with multiple ingredients. Among them, Vangadi Yoga containing Vanga Bhasma, Shilajitu, Apamarga Panchanga Churna processed with Shalmali Moola Twak Kwatha, was tested for its acute toxicity in Wistar Albino rats.
Aims: The article focuses on acute toxic effects of Vangadi Yoga as per OECD test guideline 423.
Methods and Materials:
Acute toxicity study was carried out in accordance with OECD Test Guideline 423 using nine healthy adult male Wistar Albino rats (8-10 weeks old) divided into three experimental groups (n = 3 rats/group). Vangadi Yoga was given orally as a single dose in two groups of animals using the sequential dose levels of 300 mg/kg (intermediate dose) and 2000 mg/kg (limit test dose) dissolved in 0.5% CMC solution. In vehicle control group, only 0.5% CMC solution was administered.
Results:
After 14 days of observation, no mortality or major signs of clinical toxicity were found following administration of Vangadi Yoga at either 300 mg/kg or 2000 mg/kg. Body weight increased normally throughout the study. Gross pathological examination revealed no treatment-related abnormalities. However, few histopathological changes were observed, including focal tubular necrosis in the kidney, focal gliosis in the brain, mucosal gland hypertrophy in the stomach, and coronary congestion without ischemic changes in a few animals at limit dose.
Conclusion:
Vangadi Yoga demonstrated low acute oral toxicity, with LD50 value greater than 2000 mg/kg body weight according to OECD Test Guideline 423. Although no mortality or severe clinical toxicity was observed, minimal-to-mild microscopic lesions were identified in selected organs at the limit dose. These findings indicate a preliminary favorable acute safety profile, while highlighting the need for repeated-dose toxicity studies incorporating biochemical and hematological assessments to comprehensively establish the safety of the formulation.
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