Safety evaluation of a natural eggshell membrane-derived product
Kevin J. Ruff a, John R. Endres b,⇑, Amy E. Clewell b, James R. Szabo c, Alexander G. Schauss b
Natural Eggshell Membrane (NEM) is a novel dietary ingredient that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues. NEM was evaluated for safety via in vitro and in vivo toxicological studies. This included testing for cytotoxicity, genotoxicity, acute oral toxicity, and 90-day repeated-dose oral toxicity. NEM did not exhibit any cytotoxic effects at a dose of 100 lg in an in vitro human cell viability assay after incubation for up to 20 h. NEM did not exhibit any genotoxic effects in an in vitro assay of four strains of histidine-dependent Salmonella typhimurium and one strain of tryptophan-dependent Escherichia coli at a dose of up to 5000 lg/plate. NEM did not exhibit any signs of acute toxicity in rats at a single oral dose of up to 2000 mg/kg body weight, nor signs of toxicity (via urinalysis, hematology, clinical chemistry, or histopathological evaluation) in rats at a repeated oral dose of up to 2000 mg/kg body weight per day for 90 days. The results of these studies suggest that NEM may be safe for human consumption."