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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Intraperitoneal administration of test substance (not justified), only 4 animals per dose, no toxicity measurements in the bone marrow included.
Data source
Reference
- Reference Type:
- publication
- Title:
- Study of artificial flavouring substances for mutagenicity in the Salmonella/microsome, Basc and micronucleus tests.
- Author:
Wild D, King MT, Gocke E, Eckhardt K.- Year:
- 1 983
- Bibliographic source:
- Food Chem Toxicol. 1983 Dec;21(6):707-19.
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- Intraperitoneal administration of test substance, sampling at different time intervals after single exposure (24, 48 and 72 hours)
- Qualifier:
- according to guideline
- Guideline:
- other: M. Salamone et al. Towards an improved micronucleus test Studies on 3 model agents. In Mutation Research/Environmental Mutagenesis and Related Subjects, Volume 74, Issue 5, 1980, Pages 347-356, ISSN 0165-1161.
- GLP compliance:
- no
- Type of assay:
- other: Micronucleus test
Test material
- Reference substance name:
- 2-ethyl-3-hydroxy-4-pyrone
- EC Number:
- 225-582-5
- EC Name:
- 2-ethyl-3-hydroxy-4-pyrone
- Cas Number:
- 4940-11-8
- Molecular formula:
- C7H8O3
- IUPAC Name:
- 2-ethyl-3-hydroxy-4H-pyran-4-one
- Test material form:
- solid
1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas GmbH, Kisslegg
- Age at study initiation: 10-14 weeks
- Diet: Altromin standard chow ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: olive oil
- Frequency of treatment:
- Two doses (at 0h and 24h) or single dose (at 0h)
- Post exposure period:
Groups exposed twice: 30h
Groups exposed once: 24h, 48h, 72h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 980 mg/kg bw (total dose)
- Remarks:
- Administered as single dose (0h) or dosed twice (0h and 24h)
- Dose / conc.:
- 700 mg/kg bw (total dose)
- Remarks:
- Administered twice (0h and 24h)
- Dose / conc.:
- 420 mg/kg bw (total dose)
- Remarks:
- Administered twice (0h and 24h)
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- none
Examinations
- Tissues and cell types examined:
- polychromatic erythrocytes in the bone marrow
- Details of tissue and slide preparation:
DETAILS OF SLIDE PREPARATION:
Bone-marrow smears were prepared 24h, 30h, 48h or 72h after treatment. The smears were stained according to the method of Schmid (1976).
METHOD OF ANALYSIS:
Slides were scored as previously described (Wild, King & Eckhardt, 1980).- Evaluation criteria:
- no data
- Statistics:
- Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970)
Results and discussion
Test results
- Key result
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Additional information on results:
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no effect
- Ratio of PCE/NCE (for Micronucleus assay) was not examined
Any other information on results incl. tables
Results of micronucleus tests on mouse bone marrow after exposure to Ethyl Maltol
Dose (mg/kg) | Surviving/treated mice | Mean no. of micronucleated PE/1000 PE |
0 | 4/4 | 1.3 |
2*980 | 4/4 | 3.0 |
2*700 | 4/4 | 3.2 |
2*420 | 4/4 | 2.3 |
0 | 4/4 | 2.7 |
1* 980 (24 hr) | 4/4 | 1.3 |
1* 980 (48 hr) | 4/4 | 3.5 |
1* 980 (72 hr) | 4/4 | 1.8 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, Ethyl Maltol did not induce any increase in micronucleated erythrocytes after peritoneal injection in mice.
- Executive summary:
In an NMRI mouse mammalian erythrocyte micronucleus test (Wild et al., 1983), groups of 4 female mice were treated intraperitoneally with Ethyl Maltol in olive oil at doses of 980 mg/kg bw (one dose) or 480, 700, 980 mg/kg bw (two doses 0hrs, 24hrs). Animals were sacrificed 24, 48 or 72 hrs after single treatment, or 30 hours after the second treatment.
Slides were scored for the mean number of micronucleated PE/1000PE (Polychromatic Erythrocytes). After two exposures to 980, 700, 420 or 0 mg/kg bw, the mean numbers of micronucleated PE/100PE were 3.0, 3.2, 2.3 and 1.3 respectively. After a single exposure to 980 mg/kg bw (24, 48, 72 hrs), the number of micronucleated PE/1000PEs were 1.3, 3.5 and 1.8 respectively, with a control value of 2.7. No statistically significant differences were observed. The results of these tests therefore indicate no mutagenic potential of the test substance.
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