The 5-KDF safety file: published for anyone to check
Five public studies. OECD-aligned genotoxicity testing. Human-relevant mechanistic data. Osmolarity controls. Published with DOIs.
We publish our safety science so that anyone can read it.
Today, Fooditive is making the complete safety profile of Fooditive Sweetener® Keto-Fructose (5-keto-D-fructose, 5-KDF) publicly available. If an ingredient is built for the real world, its evidence should be visible to the world.
The standard: ethics meet rigor
Our approach to safety is a set of engineering requirements. We believe that “responsible innovation” only counts when it survives contact with hard data.
- Animal welfare (the 3Rs): we replace animal testing wherever scientifically justified.
- Human relevance: we use human intestinal and hepatic models that mimic real biology and real exposure.
- Scientific integrity: we rely on standardized methods, controlled test materials, and full traceability.
The proof pack: what we published
We have released a safety-focused package designed around strict regulatory expectations. This data is now open for independent toxicologists, regulators, and competitors to evaluate.
Why test conditions matter
Study 5 explains how test conditions affect results for sugars like 5-KDF. Three factors matter: material purity and stability, osmolarity controls for high sugar concentrations, and endpoints that are relevant to human safety.
The open-access files
Fooditive has published a complete, open-access safety dossier for 5-KDF. All studies are publicly available, fully traceable, and linked below.
Study 1 — Genotoxicity: bacterial reverse mutation (Ames test)
OECD Test Guideline 471
- Five bacterial strains (Salmonella typhimurium and Escherichia coli)
- Tested with and without metabolic activation (S9)
- Doses up to 5,000 µg/plate
- Result: non-mutagenic
Study 2 — Genotoxicity: in vitro mammalian chromosomal aberration
OECD Test Guideline 473
- Human peripheral blood lymphocytes
- Tested with and without metabolic activation
- Result: non-clastogenic
Study 3 — Human intestinal safety model
Caco-2 human intestinal epithelial cells
- Assessed cytotoxicity, oxidative stress, mitochondrial function, and apoptosis
- Included iso-osmolar controls (mannitol, glucose, fructose)
- Exposure up to 200 mM
- Result: no intrinsic cytotoxicity at ≤100 mM; high-dose effects attributable to osmotic stress
Study 4 — Human hepatic safety model
HepG2 human liver cells
- Evaluated cell viability and metabolic stress
- Human-relevant hepatic exposure model
- Result: no adverse effects on viability or metabolic function
Zenodo record: zenodo.org/records/18215627
Study 5 — Material characterization and reconciliation analysis
- Compares purified crystalline 5-KDF with earlier non-crystalline test material
- Shows the role of impurities and catalytic residues, in-situ Maillard chemistry, and missing osmotic controls
- Purpose: explains how these factors can produce toxicity signals that are not intrinsic to the substance
Zenodo record: zenodo.org/records/18218216
Our commitment
We will continue to publish safety-relevant work in a way that is ethically grounded, scientifically testable, and regulator-ready.
We don’t ask the world to trust us. We publish the evidence so you don’t have to.
Scientific feedback welcome: safety@fooditivegroup.com
