Toxicological Study of a Siddha Sastric Formulation Arumuga Chendhuram in Rat Model

The study was aimed to profile the acute and sub-acute oral toxicity of a herbo-metallic drug Arumuga Chendhuram (AC). AC was prepared classically and analyzed for elemental composition using X-ray Fluorescence. Acute oral toxicity study was done on female rats at AC 2 g/kg as single administration following OECD guideline 423. For sub acute toxicity study, AC was administered orally for 28 consecutive days suspended in vehicle (Honey + distilled water) to rats following OECD guideline 407. Four groups was allotted (10 rats/group), control received vehicle; the other received AC at 12, 24 & 48 mg/kg/day respectively. Mortality and abnormal clinical signs were observed. Haematological and biochemical parameters were analyzed using auto analyzer with standard kits and ANOVA-Dunnett test was performed for significant analyses. Gross necropsy and histopathology studies using H&E stain were done on major organs. Mercury and Lead were found more than the WHO permissible limits in XRF study. LD50 was found more than 2 g/kg. No-Observed-Adverse-Effect level of AC was seen at 24 mg/kg in 28 days of treatment. No abnormal findings were noted in high dose group organs. Administration of AC at its human therapeutic dose of 260 mg/kg in rat (24 mg/kg) is safe.