Magnesium stearate is widely used in the production of dietary supplement and pharmaceutical tablets, capsules and powders as well as many food products, including a variety of confectionery, spices and baking ingredients. Although considered to have a safe toxicity profile, there is no available information regarding its potential to induce genetic toxicity. To aid safety assessment efforts, magnesium sulfate was evaluated in a battery of tests including a bacterial reverse mutation assay, an in vitro chromosome aberration assay, and an in vivo erythrocyte micronucleus assay. Magnesium stearate did not produce a positive response in any of the five bacterial strains tested, in the absence or presence of metabolic activation. Similarly, exposure to magnesium stearate did not lead to chromosomal aberrations in CHL/IU Chinese hamster lung fibroblasts, with or without metabolic activation, or induce micronuclei in the bone marrow of male CD-1 mice. These studies have been used by the Japanese government and the Joint FAO/WHO Expert Committee on Food Additives in their respective safety assessments of magnesium stearate. These data indicate a lack of genotoxic risk posed by magnesium stearate consumed at current estimated dietary exposures. However, health effects of cumulative exposure to magnesium via multiple sources present in food additives may be of concern and warrant further evaluation.
Keywords: 2AA, 2-aminoanthracene; 9AA, 9-aminoacridine hydrochloride monohydrate; ADI, acceptable daily intake; AF-2, 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide; DMSO, dimethyl sulfoxide; DNA damage; Dietary supplement; EFSA, European Food Safety Authority; ENNG, N-ethyl-N'-nitro-N-nitrosoguanidine; FAO, Food and Agriculture Organization of the United Nations; FDA, U.S. Food and Drug Administration; Food additive; GLP, Good Laboratory Practice; Genotoxicity; JECFA, Joint FAO/WHO Expert Committee on Food Additives; Joint FAO/WHO Expert Committee on Food Additives (JECFA); MMC, mitomycin C; MN, micronucleus or micronuclei; MN-PCE, micronucleated polychromatic erythrocyte(s); Magnesium stearate; OECD, Organization for Economic Cooperation and Development; PCE, polychromatic erythrocyte(s); WHO, World Health Organization.