Genotoxicity and subchronic toxicity evaluation of dried Euglena gracilis ATCC PTA-123017

- Euglena gracilis and paramylon may have potential use as functional food ingredients in human and animal nutrition.
- In vitro genotoxicity and 90-day subchronic oral toxicity study of E. gracilis and paramylon were tested.
- E. gracilis was not genotoxic in a bacterial reverse mutation test and mammalian micronucleus test.
- E. gracilis and paramylon showed no toxicity to rats at concentration tested up to 50,000 ppm for 90 days.

Euglena gracilis is a microalga capable of synthesizing various nutrients of interest in human and animal nutrition. When cultivated aerobically in the dark, Euglena synthesize paramylon, a storage polysaccharide comprised of high molecular weight beta-1,3-D-glucose polymers organized in cytoplasmic granules. Beta-glucans have been shown to have immune modulation effects, including anti-microbial, anti-tumor, and anti-oxidant properties, and metabolic effects, such as regulation of cholesterol and blood sugar levels. Preparations of E. gracilis and paramylon may therefore have potential utility as functional food ingredients for human and animal nutrition. A battery of toxicological studies was conducted on a dried preparation of E. gracilis and paramylon to support their safe food use. The dried alga was not genotoxic in a bacterial reverse mutation test and mammalian micronucleus test. In the subchronic toxicity study, rats were provided E. gracilis in the diet at levels of 0, 12,500, 25,000 or 50,000 ppm. Paramylon was provided at a concentration of 50,000 ppm. No effects that could be attributable to treatment were observed in clinical observations, body weight, food consumption, ophthalmology, hematology and clinical chemistry, urinalysis, and macroscopic and microscopic findings. A NOAEL of 50,000 ppm in the diet was determined for both ingredients.