Standardization and assessment of acute dermal toxicity of an Ayurvedic medicine Brihat Somraji Taila in Sprague-Dawley rats.

Brihat Somraji Taila (BSO), an Ayurvedic oil preparation, is used topically to treat various bacterial and fungal skin diseases. The current study standardized the BSO preparation and evaluated its acute dermal toxicity in Sprague-Dawley rats. Phytochemicals of BSO were investigated, and compliance with analytical parameters was tested. GC-MS analysis was conducted with hot water extract of BSO, presence of heavy metals and physiochemical parameters were analyzed. Acute dermal toxicity of BSO (2000 mg/kg; topical) was conducted as per OECD 402 guideline. Dermal reactivity was assessed using the Draize scoring criteria. BSO meets optimal parameters and is devoid of lead and arsenic contamination. Over 34 phytochemicals were found including Amine, Phenol, Fatty acid and Amino acid. In acute dermal toxicity study, BSO did not alter any clinical signs and no mortality or moribund was witnessed; body weights of control and BSO groups did not change significantly. The primary irritation index (PII) was 0.17. No significant changes were noted in hematological and biochemical parameters, lipid profile and histological findings compared with control rats. BSO's single dose topical application in rats exhibited no adverse effects or cutaneous toxicity, suggesting that the LD50 of BSO is greater than 2000 mg/kg for the acute dose.