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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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: 14 week repeated dose toxicity by inhalation route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conduction and documentation of study acceptable. Literature reference and study report available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Materials and methods
- GLP compliance:
- yes
Test material
- Details on test material:
- Purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: COBS, CDF (F-344/CrlBR)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- 2,4-pentanedione concentration in the exposure chamber measured every 33 min during the exposure.
- Duration of treatment / exposure:
- 6 h/d; 7d/week
- Frequency of treatment:
- 14 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 100, 300, 650 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.409, 1.226, 2.656 mg/L
Basis:
nominal conc.
- No. of animals per sex per dose:
- 20 Male and 20 female rats per group, with half being sacrificed at the end of exposure period and the remaining after a 4 week recovery period for the determination of the reversibility of observable effects.
Additionally 10 male rats were added to control and high dose groups for glutaraldehyde perfusion and subsequent ultrastructural examination of sciatic nerves.
Examinations
- Parental animals: Observations and examinations:
- Clinical signs of toxicity: daily
Ophtalmoscopy of the eye: prior to the first exposure and at sacrifice
Neurobehavioral screening: modified Irwin screen ; monthly before, during and after exposure
Body weight: weekly during the study and before sacrifice
Food and water consumption for 15 h in metabolic cages during the last exposure week (urin collection)
Organ weights (liver, kidneys, lungs, brain, heart, thymus and testes), urine chemistry (n=10 each group), serum chemistry and haematology of blood samples collected at the end of exposure or the 4-week recovery. - Postmortem examinations (parental animals):
- Gross pathology at termination in all groups.
Histopathology (nasal turbinates, larynx, trachea, lungs, epididymides, testes, spleen, thymus, urinary bladder, adrenal glands, brain (5 sections), thyroides, parathyroides, heart, kidneys, pituitary, skeletal muscle (gastronemius), stemal bone, spinal cord (lumbosacral region) and liver) in high dose, mid dose females and control group as well as brains of the mid dose group were processed for histopathology.
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Toxicity results:
In all surviving males the mean testes weights and testes weights expressed as % of organ weight determined on necropsy right at the end of the study were not different from controls in any treatment group . The same observation was made for animals of the recovery group. No histopathological changes were noted in the testes and epididymis in any dose group of surviving males examined immediately after study termination and after a 4 week recovery period, respectively. One/10 control animals of the recovery group was diagnosed with epididymitis. In male animals of the high dose group which died during exposure atrophy of the seminal vesicles were seen in four males and degeneration of the seminiferous tubules in two animals. In the female rats uterus, cervix and ovaries were subject to histopathological examination. No pathological findings were observable after gross and microscopical examination of uterus, cervix and ovaries in any treatment group immediately after study termination. In females of the recovery group ovarial cysts ("cystic ovarian bursa") were found in 2/10 animals of the control group but none in the treated groups. One/10 animals each of the control and intermediate dose group had changes in uterus size ("luminal ectasia") while 1/10 animals of the intermediate dose group had size changes in the cervix ("luminal ectasia").
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 2.656 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no histopathological effects on testes, epididymitis, uterus, cervix and ovaries were observed.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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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