Volume 43, Issue 6 p. 887-912
RESEARCH ARTICLE

Toxicological evaluation of protein powder derived from Cupriavidus necator

Vickie Modica

Corresponding Author

Vickie Modica

AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, Washington, 98122 USA

Correspondence

Vickie Modica, AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, WA 98122, USA.

Email: [email protected]

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Róbert Glávits

Róbert Glávits

Toxi-Coop Zrt., Berlini utca 47–49, H-1045, Budapest, Hungary

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Timothy S. Murbach

Timothy S. Murbach

AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, Washington, 98122 USA

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John R. Endres

John R. Endres

AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, Washington, 98122 USA

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Gábor Hirka

Gábor Hirka

Toxi-Coop Zrt., Berlini utca 47–49, H-1045, Budapest, Hungary

Toxi-Coop Zrt., Arácsi út 97, 8230, Balatonfüred, Hungary

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Adél Vértesi

Adél Vértesi

Toxi-Coop Zrt., Arácsi út 97, 8230, Balatonfüred, Hungary

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Erzsébet Béres

Erzsébet Béres

Toxi-Coop Zrt., Arácsi út 97, 8230, Balatonfüred, Hungary

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Ilona Pasics Szakonyiné

Ilona Pasics Szakonyiné

Toxi-Coop Zrt., Berlini utca 47–49, H-1045, Budapest, Hungary

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First published: 04 January 2023
Citations: 2

Adél Vértesi, Erzsébet Béres, and Ilona Pasics Szakonyiné are co-senior authors.

Funding information: The authors disclose that financial support for the research described herein was provided by Kiverdi, Inc., Pleasanton, CA.

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.

CONFLICT OF INTEREST

The authors have no conflict of interest to report.

DATA AVAILABILITY STATEMENT

The data sets generated during these studies are available in the Supporting Information.