Genotoxicity and subchronic toxicity evaluation of dried Euglena gracilis ATCC PTA-123017.
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.
Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, ON L5N 2X7, Canada.
Ryan R
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Simon
Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, ON L5N 2X7, Canada.
Trung D
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Algal Scientific Corporation, 14925 Galleon Court, Plymouth, MI 48170, USA. Electronic address: robert.levine@algalscientific.com.
Robert
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Levine
D000284:Administration, Oral; D000818:Animals; D004269:DNA, Bacterial / Q000187:drug effects / Q000235:genetics; D003890:Desiccation; D004305:Dose-Response Relationship, Drug; D005056:Euglena gracilis / Q000378:metabolism*; D005260:Female; D059022:Food Safety; D055951:Functional Food / Q000633:toxicity*; D005936:Glucans / Q000008:administration & dosage / Q000378:metabolism / Q000633:toxicity*; D006801:Humans; D008297:Male; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D015162:Micronucleus Tests; D016296:Mutagenesis; D009152:Mutagenicity Tests / Q000379:methods*; D019055:No-Observed-Adverse-Effect Level; D011208:Powders; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D013997:Time Factors; D059550:Toxicity Tests, Subchronic / Q000379:methods*
D004269:DNA, Bacterial; D005936:Glucans; D011208:Powders; C003045:paramylon
Genotoxicity; NOAEL; Rat; Safety; Toxicity