Safety assessment of the microalgae .

is a marine-water microalgae that is considered to be a good source of omega-3 fatty acids, specifically eicosapentaenoic acid (EPA), utilized in the production of an omega-3 oil for use as a dietary supplement. This study investigates the safety of in male and female Sprague-Dawley rats administered a 0 or 10 mL/kg bw/rat (10E8 viable cells/mL) suspension by oral gavage once daily for 14 consecutive days. No mortalities occurred and no signs of toxicity were observed during the study. No treatment-related effects were seen for body weight, food consumption, urinalysis, clinical chemistry, hematology, gross pathology, organ weights, or histopathology. Although statistically significant effects were noted for some endpoints, none were considered to be of toxicological significance. The suspension was concluded to have no toxicity in rats, confirming that the algal strain used in the production of omega-3 oil is not pathogenic when administered orally to rats.