Abstract
Consumers are demanding plant-based alternative protein sources to complement traditional animal-based protein sources to fulfill their dietary protein requirements. KALGAE™, a dried algal biomass derived from Klebsormidium flaccidum var. ZIVO, is a potential source of plant-based protein that has been evaluated for safety to support its use as a food ingredient. There were no treatment-related adverse effects observed in the 14-day palatability/toxicity or 90-day dietary toxicity study in CRL Sprague-Dawley CD® IGS rats. In the 90-day study, KALGAE™ was administered to rats in the diet at 0, 37,500, 75,000, or 150,000 ppm. No adverse effects were attributed to the test substance for the following parameters: body weight, body weight gain, mean food consumption and efficiency, hematology, clinical chemistry, urinalysis, gross pathology, histopathology, or organ weights. Although some statistically significant effects were recorded, the effects were not considered to be of toxicological relevance. A No Observable Adverse Effect Level (NOAEL) of 150,000 ppm, equivalent to dietary intakes of 7895.2 (male) and 9708.09 (female) mg KALGAE™/kg body weight/day in rats was established. KALGAE™ was non-mutagenic in the in vitro bacterial reverse mutation assay at concentrations up to 5000 μg/plate (with or without S9 metabolic activation), nor was KALGAE™ genotoxic in the in vivo mammalian erythrocyte micronucleus test in Swiss albino (ICR) mice. These results support the safe use of KALGAE™ as an ingredient in foods.