Comprehensive Genotoxicity and 28-Day Oral Toxicity Evaluation Reveal Safety of a Standardized Anisomeles...

Anisomeles indica is widely used in traditional medicine and functional foods; however, its toxicological safety has not been systematically evaluated. This study evaluated the genotoxicity and subacute oral toxicity of a standardized A. indica-containing powder (AIHP) using OECD-compliant test guidelines. Genotoxicity was assessed via the bacterial reverse mutation test (OECD 471), in vitro chromosomal aberration test (OECD 473), and in vivo micronucleus assay in mice (OECD 474). A repeated-dose 28-day oral toxicity study (OECD 407) was performed in Sprague-Dawley rats at doses of 2000, 4000, and 8000 mg/kg/day. AIHP did not induce mutagenicity, chromosomal aberrations, or micronucleus formation in any assay. No treatment-related mortality, clinical signs, or adverse changes in body weight, hematology, serum biochemistry, organ weights, urinalysis, or histopathology were observed. The no-observed-adverse-effect level (NOAEL) was established at 8000 mg/kg/day. These results support the toxicological safety of AIHP and its suitability for use as a health food ingredient.