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अमूर्त

Safety Assessment of Thymoquinone-rich Black Cumin (Nigella sativa) Oil (BlaQmax®): Acute and Sub-chronic Toxicity Studies

Kannan Ramalingam, Ramadasan Kuttan, Syam Das Sivadasan, Sibi Ittiyavirah and Krishnakumar Illathu Madhavamenon*

Background: Despite the increasing usage of black cumin (Nigella sativa) oil as dietary supplements/Nutraceuticals, systematic investigations on the role of its major bioactive component thymoquinone (TQ) on safety aspects have not been reported so far. Method: Herein, we report the safety of BCO containing various concentrations of TQ (0.6% and 5% w/w) by single dose acute and 90 days oral toxicity studies in Wistar rats, as per OECD guidelines. Results: While BCO with 0.6% (w/w) of TQ content was safe at 300 to 2000 mg/kg b.wt. upon single dose oral acute toxicity study, LD50 cut off dosage for BCO with 5% TQ (BCO-5) was in the range 50-300 mg/kg b. wt. Further repeated dose 90 days study at 0.1, 0.05 and 0.01 mL/kg of BCO-5 (i.e., at 5, 2.5 and 1 mg of TQ/kg b.wt.) established its NOAEL (no observed adverse effect level) as 0.1 mL/kg (5 mg of TQ/kg b.wt.). Conclusion: Black cumin oil containing 5% (w/w) of TQ content established its NOAEL as 0.1 mL/kg body weight (94 mg/kg b.wt.) which corresponds to 5 mg of TQ per kg b.wt. in rodents and at a level not exceeding 50 mg of TQ/adult/day in humans.