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

Simon, Ryan; Vo, Trung D.; Levine, Robert B.

doi:10.1016/j.yrtph.2016.06.007

Cited by 14 publications

(16 citation statements)

References 23 publications

(26 reference statements)

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“…Test article E. gracilis ATCC 12894 whole cell biomass is the dried biomass of E. gracilis ATCC 12894 cultured under heterotrophic conditions in the absence of light. E. gracilis ATCC 12894 whole cell biomass (whole cell biomass) has the following compositional profile: 33.8% protein, 28.8% -glucans, 19.8% fat, 7.1% ash, and 2.8% moisture.…”

Section: Methodsmentioning

confidence: 99%

“…(VIII. 19.) EMMI decree of the Ministry of Human Capacities which corresponds to the OECD GLP, ENV/MC/CHEM (98) 17.…”

Section: Bacterial Reverse Mutation (Ames) Testmentioning

confidence: 99%

“…1 The purpose of the studies described in this report was to assess the toxicity of the whole cell biomass of E. gracilis ATCC 12894, cultured in the absence of light to encourage protein production. The resulting biomass is 33.8% protein, 28.8% -glucans (carbohydrate), 19.8% fat, 7.1% ash, and 2.8% moisture. The majority of the carbohydrates in the test article were measured to be -glucans.…”

Section: Introductionmentioning

confidence: 99%

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Safety assessment of Euglena gracilis ATCC 12894 whole cell biomass

Symonds¹,

Zhang²,

Noble³

et al. 2019

Toxicology Research and Application

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A safety assessment of the dried whole cell biomass of Euglena gracilis ATCC 12894 was performed by the bacterial reverse mutation (Ames) assay, an in vitro micronucleus assay, and a 90-day repeat oral toxicity study in Wistar rats. E. gracilis ATCC 12894 whole cell biomass has no added excipients and contains 33.8% protein, 28.8% -glucans, 19.8% fat, 7.1% ash, and 2.8% moisture. The bacterial reverse mutation assay found no evidence of mutagenicity after exposure to E. gracilis ATCC 12894 whole cell biomass, with or without metabolic activity, at levels up to 1581 mg/plate, the limit dose for the assay. Similarly, no evidence of genotoxicity was observed in the micronucleus assay, with or without metabolic activation, up to 320 mg/mL, the limit dose for the assay. The subchronic toxicity study was performed with the following test article dose groups: 0 (control), 1250, 2500, and 5000 mg/kg/day, administered to male and female Wistar rats via oral gavage for 90 days. No test article-related mortalities or adverse events were reported during the study. Histopathological examination revealed some vacuolation in the livers of males in the 5000 mg/kg/day group. This finding was considered adaptive, due to the approximately 20% fat content of whole cell biomass, and was therefore test articlerelated, but not adverse. No such findings were reported in female rats in the study. The results of the subchronic toxicity study describe a no observed adverse effect level of at least 5000 mg/kg/day.

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Section: Methodsmentioning

confidence: 99%

“…(VIII. 19.) EMMI decree of the Ministry of Human Capacities which corresponds to the OECD GLP, ENV/MC/CHEM (98) 17.…”

Section: Bacterial Reverse Mutation (Ames) Testmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety assessment of Euglena gracilis ATCC 12894 whole cell biomass

Symonds¹,

Zhang²,

Noble³

et al. 2019

Toxicology Research and Application

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“…In addition, BG has widespread use in conventional food products, which have been regulated for food-grade specifications and BetaVia Complete has been affirmed as Generally Recognized as Safe for use in a variety of food and beverage applications. As such, it was deemed safe for human consumption [26].…”

Section: Investigational Productmentioning

confidence: 99%

Effect of a Euglena gracilis Fermentate on Immune Function in Healthy, Active Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Evans¹,

Falcone²,

Crowley³

et al. 2019

Nutrients

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Euglena gracilis produce high amounts of algal β-1,3-glucan, which evoke an immune response when consumed. This study investigated the effect of supplementation with a proprietary Euglena gracilis fermentate (BG), containing greater than 50% β-1,3-glucan, on immune function as measured by self-reported changes in upper respiratory tract infection (URTI) symptoms. Thirty-four healthy, endurance-trained participants were randomized and received either 367 mg of BG or placebo (PLA) for 90 days. Symptoms were assessed by the 24-item Wisconsin Upper Respiratory Symptom Survey and safety via clinical chemistry, hematology, vitals, and adverse event reporting. Participants supplemented with BG over 90 days reported fewer sick days (BG: 1.46 ± 1.01; PLA: 4.79 ± 1.47 days; p = 0.041), fewer URTI symptoms (BG: 12.62 ± 5.92; PLA: 42.29 ± 13.17; p = 0.029), fewer symptom days (BG: 5.46 ± 1.89; PLA: 15.43 ± 4.59 days; p = 0.019), fewer episodes (BG: 2.62 ± 0.67; PLA: 4.79 ± 0.67; p = 0.032), and lower global severity measured as area under curve for URTI symptoms (BG: 17.50 ± 8.41; PLA: 89.79 ± 38.92; p = 0.0499) per person compared to placebo. Sick days, symptoms, and global severity were significantly (p < 0.05) fewer over 30 days in the BG group compared to PLA. All safety outcomes were within clinically normal ranges. The study provides evidence that supplementation with a proprietary Euglena gracilis fermentate containing greater than 50% β-1,3-glucan may reduce and prevent URTI symptoms, providing immune support and protecting overall health.

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“…gracilis” and safety, 5 references, Simon et al. () as relevant. “E. gracilis” and illness: no references. “E.…”

mentioning

confidence: 99%

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 10: Suitability of taxonomic units notified to EFSA until March 2019

Koutsoumanis¹,

Allende²,

Álvarez‐Ordóñez³

et al. 2019

EFS2

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The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic preevaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit (TU) are, where possible and reasonable in number, reflected by 'qualifications' which should be assessed at the strain level by the EFSA's Scientific Panels. During the current assessment, no new information was found that would change the previously recommended QPS TUs and their qualifications. The list of microorganisms notified to EFSA from applications for market authorisation was updated with 47 biological agents, received between October 2018 and March 2019. Of these, 19 already had QPS status, 20 were excluded from the QPS exercise by the previous QPS mandate (11 filamentous fungi) or from further evaluations within the current mandate (9 notifications of Escherichia coli). Sphingomonas elodea, Gluconobacter frateurii, Corynebacterium ammoniagenes, Corynebacterium casei, Burkholderia ubonensis, Phaeodactylum tricornutum, Microbacterium foliorum and Euglena gracilis were evaluated for the first time. Sphingomonas elodea cannot be assessed for a possible QPS recommendation because it is not a valid species. Corynebacterium ammoniagenes and Euglena gracilis can be recommended for the QPS list with the qualification 'for production purposes only'. The following TUs cannot be recommended for the QPS list: Burkholderia ubonensis, due to its potential and confirmed ability to generate biologically active compounds and limited of body of knowledge; Corynebacterium casei, Gluconobacter frateurii and Microbacterium foliorum, due to lack of body of knowledge; Phaeodactylum tricornutum, based on the lack of a safe history of use in the food chain and limited knowledge on its potential production of bioactive compounds with possible toxic effects.

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

Cited by 14 publications

References 23 publications

Safety assessment of Euglena gracilis ATCC 12894 whole cell biomass

Safety assessment of Euglena gracilis ATCC 12894 whole cell biomass

Effect of a Euglena gracilis Fermentate on Immune Function in Healthy, Active Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 10: Suitability of taxonomic units notified to EFSA until March 2019

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