Genotoxicity of Carbohydrate Derived Fulvic Acid

Naturally derived and extracted fulvic acids have been used for immune modulation, antioxidant, diuretic, and antihypertensive applications for centuries. However, fulvic acid materials from the environment vary substantially in composition and may contain impurities such as heavy metals, increasing the toxicological risk to consumers when using these products. To overcome compositional variability and avoid environmental contaminants, carbohydrate-derived fulvic acid (CHD-FA) was developed by wet oxidation of sucrose using only molecular oxygen and water, and is manufactured under GMP via a patented process. To determine the genotoxicity of CHD-FA, we evaluated its potential toxicity using the OECD bacterial reverse mutation (Ames) test, the in vitro mammalian cell micronucleus test and the mammalian erythrocyte micronucleus test. In the Ames test, CHD-FA did not induce reverse mutations in either S. typhimurium or E. coli, nor did it increase the number of revertant bacterial colonies due to base-pair substitution or frameshift mutations. Furthermore, CHD-FA did not affect the Micronucleated Polychromatic Erythrocyte (MNPCE) count or Polychromatic/Normochromatic (PCE/NCE) ratio in an in vivo micronucleus test. A weak genotoxic effect was observed in human lymphocytes. This may have been due to extrinsic factors, such as the pH of the test solution, rather than because of the CHD-FA. These data indicate that CHD-FA is not genotoxic in the experimental models used.