RESUMEN
Melissa officinalis (lemon balm) has a long history of safe use as an aromatic herb, flavoring, tea, food supplement, and traditional medicine. An aqueous extract of the leaves of M. officinalis is intended for use as a food ingredient, however the existing safety database does not contain any high quality toxicological studies to support safe consumer exposure. Therefore, a standard tier 1 genotoxicity battery (bacterial reverse mutation and in vitro mammalian cell micronucleus tests) and a 90-day repeated dose oral toxicity study in rats were conducted in accordance with GLP and OECD guidelines. The genotoxicity studies confirmed that aqueous lemon balm extract is not genotoxic at up to the highest concentrations tested (5000 µg/plate or 5000 µg/mL). A non-GLP 14-day dose range finding study was conducted prior to the 90-day study to confirm dietary administration of aqueous lemon balm extract at concentrations of 0, 0.5, 1.6, or 5.0%. The 90-day study was conducted using the established dietary concentrations and no test substance-related adverse effects on clinical, hematological, biochemical, macroscopic, or histopathologic parameters were reported. Thus, the no-observed-adverse-effect-level was determined to be at least 3046.1 and 3720.9 mg/kg body weight/day (the highest doses tested) for male and female rats, respectively.