title: Safety evaluation of a natural eggshell membrane-derived product.
abstract: 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 μg 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 μg/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.
authors.affiliation: ESM Technologies, LLC, 2213 Missouri St., Carthage, MO 64836, USA. kruff@esmingredients.com
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Ruff
authors.forename: John R
authors.initials: JR
authors.lastname: Endres
authors.forename: Amy E
authors.initials: AE
authors.lastname: Clewell
authors.forename: James R
authors.initials: JR
authors.lastname: Szabo
authors.forename: Alexander G
authors.initials: AG
authors.lastname: Schauss
mesh_terms: D000284:Administration, Oral; D000818:Animals; D019587:Dietary Supplements / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004528:Egg Shell / Q000737:chemistry*; D006801:Humans; D051381:Rats; D017207:Rats, Sprague-Dawley