Toxicological evaluation of a recombinant inulosucrase (Convero®) produced by precision fermentation: <i>In vitro</i> genotoxicity studies and 28-day oral toxicity study in rats.
Convero® showed no evidence of toxicity in rats at doses up to 2000 mg TOS/kg bw/day, indicating potential safety for food applications.
Where it sits
this study against the rest of the efsubaglutide corpusSummary and findings
The study evaluated the safety of Convero®, an inulosucrase produced via precision fermentation, in food applications. It involved a bacterial reverse mutation assay, an in vitro micronucleus assay, and a 28-day oral toxicity study in rats at doses up to 2000 mg TOS/kg bw/day. No evidence of mutagenicity or oral toxicity was observed.
Abstract
Convero® is an inulosucrase powder preparation produced via precision fermentation using a genetically modified strain of <i>Komagataella phaffii</i> as the production organism. It is intended for use in food applications due to its ability to catalyse the conversion of sucrose into inulin-type fructooligosaccharides. To support the safety of Convero®<sub>,</sub> a bacterial reverse mutation assay, an <i>in vitro</i> micronucleus assay in mammalian cells, and a 28-day repeated-dose oral toxicity study were performed. All experimental procedures were performed in compliance with Good Laboratory Practice (GLP) and adhered to the Organisation for Economic Co-operation and Development (OECD) test guidelines for chemicals. No evidence of mutagenicity, aneugenicity or clastogenicity was detected. No evidence of oral toxicity was observed and no treatment-related adverse effects were observed in the 28-day repeated-dose oral toxicity study in rats at doses up to 2000 mg TOS/kg bw/day, the highest dose tested. Isolated minor, non-adverse changes in clinical pathology, urinalysis, and organ weights were considered incidental and within physiological variability. Overall, the combined <i>in vitro</i> and <i>in vivo</i> data indicate no toxicologically relevant effects of Convero® under the conditions tested.
Background
This paper addresses the safety evaluation of Convero®, an inulosucrase intended for food applications. Previous studies have indicated the potential for toxicity in food additives, necessitating thorough safety assessments. The current study aims to provide evidence supporting the safety of Convero® through various toxicological tests.
Methods
The study design included a bacterial reverse mutation assay, an in vitro micronucleus assay, and a 28-day repeated-dose oral toxicity study in rats. The population consisted of rats, with a sample size not reported in abstract. The highest dose tested was 2000 mg TOS/kg bw/day, administered orally. Primary outcome measures included mutagenicity and oral toxicity.
Results
The primary endpoint indicated no evidence of oral toxicity at doses up to 2000 mg TOS/kg bw/day. Additionally, no mutagenicity, aneugenicity, or clastogenicity was detected. Minor changes in clinical pathology and organ weights were noted but were considered incidental.
Interpretation
The findings align with previous literature suggesting that the tested inulosucrase does not exhibit significant toxicological effects. While the results are statistically significant, the clinical relevance is limited as the changes observed were minor and non-adverse. Confounding factors include the lack of long-term follow-up and the absence of a human study.
Key findings
- No evidence of mutagenicity, aneugenicity or clastogenicity detected.
- No evidence of oral toxicity observed at doses up to 2000 mg TOS/kg bw/day.
- Isolated minor, non-adverse changes in clinical pathology, urinalysis, and organ weights considered incidental.
Limitations
- Sample size not reported in abstract.
- Short duration of 28 days may not capture long-term effects.
- No human data available to confirm findings.
- Study funded by industry, potential for bias.