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Diss Factsheets
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EC number: 208-293-9 | CAS number: 520-45-6
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Circa 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- Micronucleus test in mice on 39 food additives and eight miscellaneous chemicals
- Author:
- Hayashi et al
- Year:
- 1 988
- Bibliographic source:
- Fd. Chem. Toxic. 26, No. 6, 487-500
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Micronucleus test conducted on a Japanese government laboratories: National Institute of Hygiene Sciences and Public Health Laboratory.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate
- EC Number:
- 224-580-1
- EC Name:
- Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate
- Cas Number:
- 4418-26-2
- Molecular formula:
- C8H7O4.Na
- IUPAC Name:
- sodium 1-(6-methyl-2,4-dioxo-2H-pyran-3(4H)-ylidene)ethanolate
Constituent 1
- Specific details on test material used for the study:
- Dehydroacetic acid, sodium salt DHA-Na, CAS 4418-26-2
Supplied by Japan Food Additives Association
Purity: 99.6%
Test animals
- Species:
- mouse
- Strain:
- other: ddy - from a Japanese breeder
- Details on species / strain selection:
- Used by the laboratories.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Eight-week-old male ddY mice (Shizuoka Agri-cultural Cooperative Association for Laboratory Animals, Shizuoka) were used at both laboratories, and were allowed food pellets CE-2 (Japan Clea, Tokyo) and water ad lib. throughout the experiments.
Administration / exposure
- Route of administration:
- other: Oral and intraperitoneal
- Vehicle:
- water or normal saline
- Details on exposure:
- See any other information on materials and methods below
- Duration of treatment / exposure:
- See any other information on materials and methods below
- Frequency of treatment:
- Multiple (four or five) injections with 24-hr intervals between the injections.
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- See results for route of exposure for dosages
- Dose / conc.:
- 37.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 62.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 75 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 250 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 2-6/group for the pilot and main test
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- Mitomycin C. Additionally a number of substances were tested in this study, some of which were suspected to be genotoxic.
Examinations
- Tissues and cell types examined:
- See any other information on materials and methods below
- Details of tissue and slide preparation:
- See any other information on materials and methods below
- Evaluation criteria:
- See any other information on materials and methods below
- Statistics:
- A two-stage statistical procedure was used: the frequency of MNPCEs in each treatment group was compared with the binomial distribution specified by historical control data. In the second stage, the dose-response relationship was tested by the Cochran-Armitage trend test. A positive result was recorded only when one or more treatment group(s) showed a statistically significant difference (P <0.01) from the spontaneous level of MNPCEs and the trend test indicated a positive dose response (P < 0.05).
Results and discussion
Test resultsopen allclose all
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: intraperitoneal injection route only positive
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: oral gavage
Applicant's summary and conclusion
- Conclusions:
- Dehydroacetic acid, sodium salt DHA-Na, when dosed by oral gavage showed that there was no trend for genotoxicity. When dosed by the intraperitoneal route there was a positive trend for genotoxicity. However, as indicated in the OECD guideline 747, the appropriate route of exposure should be used, the appropriate route of potential exposure is most likely oral rather than intraperitoneal. The data therefore indicate that DHA-Na should be considered as not genotoxic.
- Executive summary:
Dehydroacetic acid, sodium salt DHA-Na, when dosed by oral gavage, at dose levels between 37.5 and 1250 mg/kg showed that there was no positive trend for genotoxicity. When dosed by the intraperitoneal
route there was a positive trend for genotoxicity. However, as indicated in the OECD guideline 747, the appropriate route of exposure should be used, the appropriate route of potential exposure is most
likely oral rather than intraperitoneal. The data therefore indicate that DHA-Na should be considered as not genotoxic.
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.
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