Acute and Subacute Oral Toxicity Study of a Herbal Formulation Containing , , and in Mice.

The synergistic activity of compounds in herbal drugs has been well established by multiple scientific studies. The compounds present in plants may have increased toxicity and increased efficacy. Owing to the notion that traditional medicines do not have any adverse effects, these are used heftily. The present study was designed to assess the toxicity of an herbal drug consisting of roots, stems, and seeds extract blend (ATTEB), which is widely employed as an antimicrobial, anti-inflammatory, immunomodulator, adaptogen, female tonic, galactagogue, etc. The current study evaluated its safety by acute (OECD 423) and subacute (OECD 407) repeated-dose toxicity studies. A phytochemical investigation was carried out and revealed the presence of principal bioactive constituents. A genotoxicity study was performed by micronucleus assay. Gross necroscopy of the animals was performed, and behavioral, hematological, biochemical, and histopathological studies were performed. In the acute toxicity study, there was no mortality and no significant changes in behavior, organ structure, or organ weight, as observed by gross necroscopy of the animals, at a single dose of 2000 mg/kg BW. In a 28-day repeated-dose toxicity study, up to a daily dose of 1000 mg/kg BW, there was no evidence of toxicity. No significant genotoxicity was observed in the mice. The LD found to be greater than 2000 mg/kg BW with NOAEL at 1000 mg/kg BW in mice. It was found to be free from any genotoxicity. The herbal drug was found to be safe to level of category 4 and can be used further for clinical studies.