Toxicological evaluation of protein powder derived from Cupriavidus necator

Microorganisms have the potential to produce nutrient‐rich products that can be consumed as food or feed. The protein‐rich powder derived from heat treatment of the whole‐cell biomass of polyhydroxybutyrate‐deficient Cupriavidus necator, a metabolically versatile organism that uses elements found in...

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Published in:	Journal of applied toxicology Vol. 43; no. 6; pp. 887 - 912
Main Authors:	Modica, Vickie, Glávits, Róbert, Murbach, Timothy S., Endres, John R., Hirka, Gábor, Vértesi, Adél, Béres, Erzsébet, Pasics Szakonyiné, Ilona
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01.06.2023
Subjects:	Animals Biocompatibility Chromosome aberrations Cupriavidus necator Female Food Genotoxicity Heat treatment Heat treatments Humans In vitro methods and tests In vivo methods and tests Male Mammals Microorganisms Mutagenicity Mutagenicity Tests No-Observed-Adverse-Effect Level NOAEL Polyhydroxybutyrate Polyhydroxybutyric acid Powder Powders - toxicity protein concentrate Proteins Rats Rats, Wistar Side effects single‐cell protein Toxicity toxicity, genotoxicity, safety Cupriavidus necator single-cell protein toxicity, genotoxicity, safety NOAEL protein concentrate
ISSN:	0260-437X, 1099-1263, 1099-1263
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Abstract	Microorganisms have the potential to produce nutrient‐rich products that can be consumed as food or feed. The protein‐rich powder derived from heat treatment of the whole‐cell biomass of polyhydroxybutyrate‐deficient Cupriavidus necator, a metabolically versatile organism that uses elements found in the air, is an example of such a product. To assess the safety of the protein powder for use as a nutritional ingredient in human food, in accordance with internationally accepted standards, its genotoxic potential and repeated‐dose oral toxicity were investigated. A bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test were performed. No evidence of mutagenicity or genotoxicity was found. Additionally, a 90‐day repeated‐dose oral toxicity study in rats was completed, in which a total of 100 male and female Wistar rats were exposed by gavage to daily doses of 1000, 2000, or 3000 mg/kg bw/day of the test material. Following 90 days of continuous exposure, no mortality or treatment‐related adverse effects were observed and no target organs were identified. Therefore, a no observed adverse effect level was determined at 3000 mg/kg bw/day, the highest dose tested. The whole‐cell biomass of polyhydroxybutyrate‐deficient Cupriavidus necator is protein rich. The derived protein concentrate has the potential for use as an environmentally sustainable nutrient‐dense food ingredient. Therefore, we assessed the genotoxic potential and oral toxicity of the heat‐treated and powdered product, in preclinical safety studies. No evidence of genotoxicity or mutagenicity was found. In a 90‐day repeated‐dose oral toxicity study, a no observed adverse effect level in rats of 3000 mg/kg bw/day, the highest feasible dose, was determined.
AbstractList	Microorganisms have the potential to produce nutrient-rich products that can be consumed as food or feed. The protein-rich powder derived from heat treatment of the whole-cell biomass of polyhydroxybutyrate-deficient Cupriavidus necator, a metabolically versatile organism that uses elements found in the air, is an example of such a product. To assess the safety of the protein powder for use as a nutritional ingredient in human food, in accordance with internationally accepted standards, its genotoxic potential and repeated-dose oral toxicity were investigated. A bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test were performed. No evidence of mutagenicity or genotoxicity was found. Additionally, a 90-day repeated-dose oral toxicity study in rats was completed, in which a total of 100 male and female Wistar rats were exposed by gavage to daily doses of 1000, 2000, or 3000 mg/kg bw/day of the test material. Following 90 days of continuous exposure, no mortality or treatment-related adverse effects were observed and no target organs were identified. Therefore, a no observed adverse effect level was determined at 3000 mg/kg bw/day, the highest dose tested.Microorganisms have the potential to produce nutrient-rich products that can be consumed as food or feed. The protein-rich powder derived from heat treatment of the whole-cell biomass of polyhydroxybutyrate-deficient Cupriavidus necator, a metabolically versatile organism that uses elements found in the air, is an example of such a product. To assess the safety of the protein powder for use as a nutritional ingredient in human food, in accordance with internationally accepted standards, its genotoxic potential and repeated-dose oral toxicity were investigated. A bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test were performed. No evidence of mutagenicity or genotoxicity was found. Additionally, a 90-day repeated-dose oral toxicity study in rats was completed, in which a total of 100 male and female Wistar rats were exposed by gavage to daily doses of 1000, 2000, or 3000 mg/kg bw/day of the test material. Following 90 days of continuous exposure, no mortality or treatment-related adverse effects were observed and no target organs were identified. Therefore, a no observed adverse effect level was determined at 3000 mg/kg bw/day, the highest dose tested. Microorganisms have the potential to produce nutrient‐rich products that can be consumed as food or feed. The protein‐rich powder derived from heat treatment of the whole‐cell biomass of polyhydroxybutyrate‐deficient Cupriavidus necator, a metabolically versatile organism that uses elements found in the air, is an example of such a product. To assess the safety of the protein powder for use as a nutritional ingredient in human food, in accordance with internationally accepted standards, its genotoxic potential and repeated‐dose oral toxicity were investigated. A bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test were performed. No evidence of mutagenicity or genotoxicity was found. Additionally, a 90‐day repeated‐dose oral toxicity study in rats was completed, in which a total of 100 male and female Wistar rats were exposed by gavage to daily doses of 1000, 2000, or 3000 mg/kg bw/day of the test material. Following 90 days of continuous exposure, no mortality or treatment‐related adverse effects were observed and no target organs were identified. Therefore, a no observed adverse effect level was determined at 3000 mg/kg bw/day, the highest dose tested. Microorganisms have the potential to produce nutrient‐rich products that can be consumed as food or feed. The protein‐rich powder derived from heat treatment of the whole‐cell biomass of polyhydroxybutyrate‐deficient Cupriavidus necator, a metabolically versatile organism that uses elements found in the air, is an example of such a product. To assess the safety of the protein powder for use as a nutritional ingredient in human food, in accordance with internationally accepted standards, its genotoxic potential and repeated‐dose oral toxicity were investigated. A bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test were performed. No evidence of mutagenicity or genotoxicity was found. Additionally, a 90‐day repeated‐dose oral toxicity study in rats was completed, in which a total of 100 male and female Wistar rats were exposed by gavage to daily doses of 1000, 2000, or 3000 mg/kg bw/day of the test material. Following 90 days of continuous exposure, no mortality or treatment‐related adverse effects were observed and no target organs were identified. Therefore, a no observed adverse effect level was determined at 3000 mg/kg bw/day, the highest dose tested. The whole‐cell biomass of polyhydroxybutyrate‐deficient Cupriavidus necator is protein rich. The derived protein concentrate has the potential for use as an environmentally sustainable nutrient‐dense food ingredient. Therefore, we assessed the genotoxic potential and oral toxicity of the heat‐treated and powdered product, in preclinical safety studies. No evidence of genotoxicity or mutagenicity was found. In a 90‐day repeated‐dose oral toxicity study, a no observed adverse effect level in rats of 3000 mg/kg bw/day, the highest feasible dose, was determined.
Author	Hirka, Gábor Murbach, Timothy S. Endres, John R. Béres, Erzsébet Glávits, Róbert Pasics Szakonyiné, Ilona Modica, Vickie Vértesi, Adél
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Notes	Funding information Adél Vértesi, Erzsébet Béres, and Ilona Pasics Szakonyiné are co‐senior authors. The authors disclose that financial support for the research described herein was provided by Kiverdi, Inc., Pleasanton, CA. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23
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Snippet	Microorganisms have the potential to produce nutrient‐rich products that can be consumed as food or feed. The protein‐rich powder derived from heat treatment... Microorganisms have the potential to produce nutrient-rich products that can be consumed as food or feed. The protein-rich powder derived from heat treatment...
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SubjectTerms	Animals Biocompatibility Chromosome aberrations Cupriavidus necator Female Food Genotoxicity Heat treatment Heat treatments Humans In vitro methods and tests In vivo methods and tests Male Mammals Microorganisms Mutagenicity Mutagenicity Tests No-Observed-Adverse-Effect Level NOAEL Polyhydroxybutyrate Polyhydroxybutyric acid Powder Powders - toxicity protein concentrate Proteins Rats Rats, Wistar Side effects single‐cell protein Toxicity toxicity, genotoxicity, safety
Title	Toxicological evaluation of protein powder derived from Cupriavidus necator
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