Safety evaluation of ferrous bisglycinate chelate

Ferrous bisglycinate chelate (Ferrochel(TM)dagger) is a highly stable chela te that can be added to most foods. Data from human and animal studies indi cate that the ferrous iron is readily bioavailable with fewer side-effects than the more commonly used iron salts. The acute oral LD50 for male and fe male Sprague-Dawley (S-D) rats is 2800 mg/kg body weight (560 mg/kg body we ight iron [confidence limit (CL) 399-786] as the active ingredient). Male a nd female CD (Sprague-Dawley-derived) rats were fed ferrous bisglycinate as a dietary admixture at doses: of 0, 100, 250 and 500 mg/kg body weight/day . There were no biologically or statistically significant dose-related diff erences between the control and treated animals with respect to body weight gain, food consumption, food efficiency, behavioural effects, clinical che mistries, haematology, absolute and relative organ weights, or gross and mi croscopic findings. Hepatic non-heme iron concentrations were elevated, ind icating that the ferrous iron had been absorbed. The no-observed-adverse-ef fect level (NOAEL) was 500 mg/kg body weight/day, the highest dose tested. (C) 1999 Elsevier Science Ltd. Ail rights reserved.