Assessment of dermal toxicity of mustard oil based formulation of Nerium indicum Mill.
Nerium indicum Mill. with red flowers belong to family Apocynaceae is considered as botanical source of Rakta Karavira drug of Upavisha (semi-poisonous) category of Ayurvedic Pharmacopeia of India. Till date Rakta Karavira Taila (mustard oil based formulation of root bark of Rakta Karavira) has not been evaluated pharmacologically. In present study, acute and repeated dose 28 day dermal toxicity studies of Rakta Karavira Taila was carried out in Charles foster albino rats. Acute dermal toxicity study was assessed at a single dermal application of drug at limit dose of 2000 mg/kg body weight of rats and observed for fourteen consecutive days. The repeated dose 28-day dermal toxicity study was assessed on repeated dermal applications at limit dose of 1000 mg/kg body weight of rats for 28 days consecutive days as per OECD guideline. The test medication was applied equally over a region covering rats body surface area of about 10%. Effects on body weight, haematological, ponderal changes, biochemical, and histological studies were used to evaluate the toxicity of the Rakta Karavira Taila. No mortality and toxicity were observed on single dermal application at limit dose level of 2000 mg/kg in acute dermal toxicity study. On repeated dermal applications of Rakta Karavira Taila at limit dose of 1000 mg/kg, showed statistically significant decrease in weight of testes, increase in WBC and platelet count while rest of hematological and biochemical parameters are not affected in comparison to control group. Histopathological study showed inflammation and fatty degenerative changes in liver and kidney, degenerative changes in seminiferous tubules and decrease in spermatogenesis in drug administered group. Medicated oil prepared out of root bark of Nerium indicum with red flower with mustard oil has potential to produce adverse effect particularly on male reproductive system therefore, should not be used for longer duration at higher dose level.
Acute dermal toxicity, Karavira, Nerium indicum, Rakta Karavira Taila, Sub-acute dermal toxicity
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