An evaluation of genotoxicity and 90-day repeated-dose toxicity in rats of a Dracocephalum moldavica powdered extract

The safety of a powdered extract of Dracocephalum moldavica (Dracobelle™ Nu sd) was examined through a battery of in vitro and in vivo toxicological studies including a bacterial reverse mutation test, an in vivo mammalian micronucleus assay in male NMRI mice, and a subchronic toxicity study in Han:Wist rats. No mutagenic activity was observed in any of the tested bacterial strains with or without metabolic activation in the reverse mutation test, and no evidence of clastogenic or aneugenic activity was observed in the in vivo mouse micronucleus test. In the 90-day repeated dose oral toxicity study conducted in 80 (40 male/40 female) rats at dose levels of 0 (control), 250, 500, and 1000 mg/kg bw/day, no treatment related mortality or clinical signs of toxicity were observed, and no significant adverse effects attributable to the test item were found in any of the examined parameters in accordance with the OECD guidelines. The No Observed Adverse Effect Level (NOAEL) was determined to be 1000 mg/kg bw/day in male and female rats, the highest dose tested.