Safety Evaluation of Vajra Bhasma (Diamond Ash): Acute and 90-Day Repeated-Dose Oral Toxicity Study in Wistar Albino Rats

Export Introduction: Vajra Bhasma (VB), a classically prepared diamond ash, is a medicinal substance utilized for challenging disorders like cancer in Ayurvedic science. In modern medicine, diamond nanoparticles are used for diagnostic and therapeutic purposes, but safety concerns exist. No safety study has been reported on VB, a classical Ayurvedic formulation. Methods: VB was prepared according to Rasa Tantra Sara Evam Siddha Yoga Samgraha. Acute toxicity of VB was assessed in female Wistar albino rats per OECD guideline 425. A repeated-dose 90-day oral toxicity study was conducted according to OECD Guideline 408 in Wistar albino rats (rr1), using three doses: Therapeutic equivalent dose (TED) (0.702 mg/kg, oral), TED ×5 (3.51 mg/kg, oral), TED ×10 (7.02 mg/kg, oral), and TED ×10 in the recovery phase. The vehicle control group received 1% Na-CMC in distilled water (10 ml/kg, p. o.). Results: In the 90-day study, VB administration caused a significant increase in body weight in the TED ×10 group (P < 0.05) and a 28.15% increase in the TED ×10 recovery group (P < 0.05). No significant changes were observed in organ weight, except a dose-dependent decrease in prostate weight (P < 0.05) and increase in testis weight (P < 0.05). Hematological analysis showed a significant elevation in RBC count (P < 0.05). Serum analysis revealed reduced creatinine and S. G. P. T. levels (P < 0.05 and P < 0.01, respectively) and increased serum calcium at TED ×5 (P < 0.05). VB showed no major toxicity, with normal histological findings in all examined organs. Conclusion: Vajra Bhasma is safe at tested doses in albino rats, however, further studies are needed to confirm its safety profile in human.