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Diss Factsheets
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EC number: 204-634-0 | CAS number: 123-54-6
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 001
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 483 (Mammalian Spermatogonial Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- other: mouse spermatogonia chromosomal aberration test
Test material
- Details on test material:
- Purity: 99.59%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle: Water
- Amount of vehicle: 10 mL/kg bw (negative control) - Duration of treatment / exposure:
- single application
- Frequency of treatment:
- single application
Doses / concentrations
- Remarks:
- Doses / Concentrations:
800 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Adriblastin (5 mg/kg bw)
Examinations
- Tissues and cell types examined:
- Spermatogonial cells
- Details of tissue and slide preparation:
- CITERIA FOR DOSE SELECTION:
In a preceding study the bioavailability of the test material was confirmed. It was determined that 800 mg/kg bw administered orally were close to the MTD as shown by signs of toxicity in the treated animals such as reduction of spontaneous activity, eyelid closure, apathy and tremor. In this previous test the systemic distribution of the test substance was also checked and it was found that after oral administration the test substance was detectable in blood serum up to four hours post-treatment.
TREATMENT AND SAMPLING TIMES:
For the investigation of chromosomal aberrations in germ cells, spermatogonial cells were prepared 24 and 48 hours after single test substance administration. Five male mice were examined at each time point.
METHOD OF ANALYSIS:
At least 100 metaphases per animal were scored for cytogenetic damage. Gaps, breaks, fragments, deletions, exchanges and chromosomal disintegrations were recognized as structural chromosome aberrations. - Statistics:
- Statistical analysis of results observed was included and confirmed by the non-parametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- After preparation and examination of spread spermatogonial cells (100 cells of each animal, i.e. 500 per dose and time point were analysed) no reduction in the mitotic index could be observed, indicating that 2,4-pentanedione at the indicated dose and the indicated application route was not cytotoxic for spermatogonial cells. No statistically significant or biologically relevant increase in the number of numerical and structural aberration as compared to vehicle treated controls could be found. Aberration rates were 0.8 % and 1.0 % for the 24 h and the 48 h treatment, respectively, as compared to the vehicle control value of 0.6 % . The mean aberration frequencies observed after treatment with 2,4-pentanedione were consistently below 2% aberrant cells exclusive gaps, given as the upper limit of a tolerable vehicle control value. The positive control showed a statistically significant response (9 % aberration rate excluding gaps). In conclusion, 2,4-pentanedione is being considered non-mutagenic under the conditions of this assay.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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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