Safety assessment of SIRTMAX^®, a standardized Kaempferia parviflora rhizome extract: genotoxicity and oral toxicity studies

抄録

Kaempferia parviflora has long been used in traditional medicine because of its various health benefits, including the promotion of longevity and vitality. SIRTMAX^®, a rhizome extract of K. parviflora standardized for polymethoxyflavones, is widely used as an ingredient in functional foods and dietary supplements. However, comprehensive safety data generated in accordance with internationally recognized regulatory guidelines remain limited. To comprehensively evaluate the safety of SIRTMAX^®, we conducted a battery of genotoxicity and oral toxicity studies in accordance with Good Laboratory Practice (GLP) and Organisation for Economic Co-operation and Development (OECD) guidelines. Genotoxicity was assessed using a bacterial reverse mutation test, in vitro chromosomal aberration test, and in vivo mammalian erythrocyte micronucleus test. Oral toxicity was evaluated in Sprague-Dawley rats using a 90-day repeated-dose oral toxicity study. SIRTMAX^® did not exhibit genotoxic effects in any of the assays conducted. In the 90-day repeated-dose oral toxicity study, daily oral administration of SIRTMAX^® at doses up to 1000 mg/kg body weight/day was not associated with adverse effects. Accordingly, the no-observed-adverse-effect level (NOAEL) was determined as 1000 mg/kg body weight/day. These findings provide scientific evidence supporting the safety of SIRTMAX^® for daily consumption.