Safety evaluation of Nannochloropsis gaditana oil as a novel food

To assess the safety of the Nannochloropsis gaditana oil as a new food ingredient, we conducted a comprehensive toxicological evaluation, including acute oral toxicity study, genotoxicity studies, teratogenicity study, and subchronic toxicity study. In the acute oral toxicity study, the LD₅₀ > 8.4 g/kg BW. In the genotoxicity studies (mammalian erythrocyte micronucleus, chromosomal aberrations, and Ames test), all dose groups showed no significant changes compared to negative controls. Teratogenicity study demonstrated no adverse effects on maternal body weight, reproductive capacity, or fetal development in rats, with a no-observed-adverse-effect level (NOAEL) of 2.8 g/kg BW. Similarly, the 90-day subchronic toxicity study identified a NOAEL of 2.8 g/kg BW, as no treatment-related abnormalities were observed in body weight, hematology, blood biochemistry, urinalysis, or histopathology. These findings support the safety of Nannochloropsis gaditana oil for human consumption.