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Diss Factsheets
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EC number: 225-582-5 | CAS number: 4940-11-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
The genotoxicity of the Ethyl Maltol has been assessed in vitro for two genotoxicity endpoints: mutagenicity in bacteria (Ames test) and genemutation in mammalian cells using read across from Kojic Acid. This results in a positive result in bacteria and a negative result in mammalian cells. An in vivo mammalian somatic cell study in mice with Ethyl Maltol was negative for cytogenicity.
Based on this the substance is not considered genotoxic in vitro or in vivo.
The carcinogenicity of Ethyl Maltol has been assessed in vivo in rats and dogs (Gralla et al. 1969; similar to OECD TG 453). No histopathological changes and no increases in neoplasms were seen after two years treatment with the test substance. Ethyl Maltol was evaluated by the EFSA Panel (FGE.213) which concluded that the substance is not carcinogenic based on the 24 month repeated dose toxicity study.
EFSA, 2015, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4244/epdf
Key value for chemical safety assessment
Justification for classification or non-classification
Based on all genotoxicity information the substance is not genotoxic in vitro and in vivo and it is not carcinogenic based on a carcinogenicity study. Therefore the substance does not need to be classified for carcinogenicity according to EU CLP (EC no. 1272/2008 and its amendments).
Additional information
Chronic rat (Gralla et al. 1969; similar to OECD TG 453)
Groups of 25 male and female rats were fed for two years on diets containing Ethyl Maltol [FL-no: 07.047] calculated to deliver 0, 50, 100 and 200 mg Ethyl Maltol/kg bw/day. No abnormalities were seen as regards survival, clinical appearance, growth rate or food consumption, clinical chemistry, haematology and urinalysis. No histopathological changes and no increases in neoplasms were seen after the treatment with Ethyl Maltol.
Chronic dog (Gralla et al. 1969; similar to OECD TG 453)
Groups of 8 male and female dogs were given Ethyl Maltol, in capsules, at dose levels of 200, 250 or 125 mg/kg bw/day, 5 days per week for 2 years. All levels of Ethyl Maltol were tolerated without adverse effects. No treatment-related pathologic changes were found. No histopathological changes and no increases in neoplasms were seen after the treatment with Ethyl Maltol.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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