Preclinical safety evaluation of SloIron CFTN-PS 5: A pea-derived ferritin product.

Ferritins are proteins present in plants and animals that are highly effective in storing iron and maintaining iron homeostasis. Iron deficiency anemia is a widespread nutritional disorder, and plant ferritins (phytoferritin) are potential sources of bioavailable iron with slow-release characteristics that prevent oxidative damage. These characteristics are related to receptor mediated endocytosis, the primary absorption mechanism in humans. However, the available toxicological data are insufficient to determine whether the use of phytoferritin as a nutritional supplement to enhance iron consumption in human populations is safe. Therefore, several GLP-compliant toxicology studies have been conducted with phytoferritin prepared from the seed of Psium sativum (trade name: SloIron CFTN-PS5). SloIron CFTN-PS5 was non-mutagenic and non-clastogenic in vitro and did not induce the formation of micronuclei in vivo. SloIron CFTN-PS5 was well-tolerated in a 90-day subchronic toxicity studies conducted in Sprague-Dawley rats at doses up to 1950 mg/kg bw/day. These findings suggest that the oral consumption of SloIron CFTN-PS5 is of low toxicological concern, with a 90-day oral subchronic No Observed Adverse Effect Level (NOAEL) of 1950 mg/kg-day, the highest dose tested.