Safety assessment of a lyophilized biomass of Tetraselmis chuii (TetraSOD®) in a 90 day feeding study

TetraSOD (R) is a powder of the lyophilized biomass of Tetraselmis chuii strain CCFM03, a marine microalga with a history of use as feed in the aquaculture industry. Recently, algae including T. chuii have been investigated for their potential use in human food. However, published toxicology studies addressing the safety of T. chuii as a food ingredient are not available. To address this issue, the toxicity of TetraSOD (R) was evaluated using a 90-day oral toxicology study in rats following the Organisation for Economic Co-operation and Development (OECD) test guideline 408. No treatment-related mortality or clinical signs were noted with TetraSOD (R) at doses of 625, 1667, or 2500 mg/kg/day. Additionally, no adverse effects on haematology, blood biochemistry, organ weights, gross or histopathology were observed. The Non Observed Adverse Effect Level (NOAEL) for TetraSOD (R) is greater than the highest tested dose of 2500 mg/kg/day.