Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-271-8 | CAS number: 118-71-8
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Validity of study confirmed by EFSA (FGE.213), Only tested strains TA98 and TA100, Quercetin and sterigmatocystin were used as positive controls. Max dose tested 2 mg/plate.
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of 1,2-dicarbonyl compounds: Maltol, Kojic Acid, Diacetyl and related substances
- Author:
- Bjeldanes L.F. and Chew H.
- Year:
- 1 979
- Bibliographic source:
- Mutation Research, 67 (1979) 367-371
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Ames, B.N., J. McCann and E. Yamasaki, Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test, Mutation Res., 31 (1975) 347-364.
- Deviations:
- yes
- Remarks:
- Only tested strains TA98 and TA100, Quercetin and sterigmatocystin were used as positive controls. Max dose tested 3 mg/plate.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-hydroxy-2-methyl-4-pyrone
- EC Number:
- 204-271-8
- EC Name:
- 3-hydroxy-2-methyl-4-pyrone
- Cas Number:
- 118-71-8
- Molecular formula:
- C6H6O3
- IUPAC Name:
- 3-hydroxy-2-methyl-4H-pyran-4-one
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Chemical Division, Pfizer, New York, NY
Method
- Target gene:
- hisG46/hisD3052
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Provided by B.N. Ames
- Suitability of cells: commonly used strain to detect frameshift reverse mutation - Additional strain / cell type characteristics:
- other: R factor plasmid, pKM101, deep rough coat mutation and uvrB deletion
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Provided by B.N. Ames
- Suitability of cells: commonly used strain to detect base-pair substitution reverse mutation - Additional strain / cell type characteristics:
- other: R factor plasmid, pKM101, deep rough coat mutation and uvrB deletion
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital -induced rat liver S9
- Test concentrations with justification for top dose:
- Initial study: 10 µg, 100 µg, 1 mg, 10 mg/plate
Main study: 0.5, 1, 1.5, 2 and 3 mg/plate - Vehicle / solvent:
- Filter sterilised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: Quercetin, Sterigmatocystin
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48h
DETERMINATION OF CYTOTOXICITY
- Method: not specified
NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): 3 - Rationale for test conditions:
- As described by Ames et al. (1975)
- Evaluation criteria:
- Not specified
- Statistics:
- The mean number of revertant colonies is calculated from triplicate runs, and the number of spontaneous revertants is subtracted from each value.
Further statistics were not specified.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- max dose tested 3 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- max dose tested 3 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: the publication did not mention precipitation, also not at the highest dose tested 3 mg/plate
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Cytotoxicity was not observed for maltol up to the highest concentration tested (3 mg/plate).
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, a dose related mutagenic effect was observed for Maltol against tester strain TA100 but not in strain TA98. Based on this result, the test substance is considered mutagenic.
- Executive summary:
In a reverse gene mutation assay in bacteria (Bjeldanes and Chew, 1979), strains of S. typhimurium TA 98 and TA 100 were exposed to Maltol at concentrations of 0.5, 1, 1.5, 2 and 3 mg/plate (plate incorporation) in the presence and absence of mammalian metabolic activation (Phenobarbital-induced rat liver S9). Quercetin, sterigmatocystin and benzo[a]pyrene were used as positive controls. The study was judged to be valid by the EFSA (FGE.213) and rated Klimisch 2.
The substance induced a dose-related increase in the number of revertant colonies in S. typhimurium TA100, both in the absence and presence of S9 metabolic activation. No mutagenicity was observed in strain TA98. Under the conditions of this study, the test substance is considered mutagenic.
EFSA Journal 2015;13(9):4244
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
