Toxicological studies on the botanical supplement LI12542F6 containing extracts of Sphaeranthus indicus flower heads and Mangifera indica (mango tree) bark.

LI12542F6, a botanical extract composed of Sphaeranthus indicus and Mangifera indica, was evaluated for mutagenicity in bacteria, clastogenicity in mouse bone marrow, acute oral and dermal toxicity in the rat, irritation (dermal, eye) in rabbit, and subacute and subchronic toxicity (28 and 90 days) in the rat. All studies followed standard OECD test protocols, in accordance with the principles of Good Laboratory Practice (GLP). LI12542F6 did not induce mutations in the bacterial assay using Salmonella and Escherichia coli strains, nor did it induce genotoxic effects in erythrocytes from mouse bone marrow. LI12542F6 was found to have oral and dermal LD 50 values greater than the limit dose of 2,000 mg/kg body weight in the rat. In an eye irritation/corrosion test, LI12542F6 caused conjunctival redness, corneal opacity, and chemosis and is classified as Category 2A ("irritating to eyes - reversible eye effect"). Doses in the 28-day and 90-day rat oral toxicity studies were 0, 500, 1,000, and 1,500 and 0, 1,000, 1,500, and 2,000 mg/kg body weight/day, respectively, administered by gavage. Both studies featured a recovery period. Minor effects were random and not treatment related except for local irritation of the forestomach in the 28-day study, evidenced by histopathologic examination, in mid- and high-dose animals. The frequency and severity of these effects were reduced in the recovery group; irritation was not found in the forestomach of rats in the 90-day study. The no observed adverse effect level (NOAEL) was greater than the highest dose tested, that is, >2,000 mg/kg in the 90-day study. This botanical composition will be marketed commercially for muscle health as Myotor™.