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EC number: 265-779-3 | CAS number: 65443-14-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401 with a deviation: 2 animals/sex/dose were used instead of 5 animals of the same sex/dose. This deviation is not considered to have affected the reliability of the study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 2 animals/sex/dose were used, no details test animals, environmental condition of animal room
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- EC Number:
- 265-779-3
- EC Name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- Cas Number:
- 65443-14-3
- Molecular formula:
- C13H24O
- IUPAC Name:
- 2,2,5-trimethyl-5-pentylcyclopentan-1-one
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 0977/1 100%
- Physical state: Clear, colourless liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD® Strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts, USA.
- Weight at study initiation: Males: 152-226 g; females: 146-162 g
- Fasting period before study: Animals were fasted for 24 h before dosing.
- Housing: Animals were housed in suspended, wire-mesh stock cages.
- Diet: Purina® Rat Chow® 5012 (Ralston Purina Company, St. Louis, Missouri, USA), ad libitum
- Water: Water, ad libitum
- Acclimation period: 5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 900, 3038 and 6834 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Animals were observed for mortality and clinical signs daily for 14 days. Initial and final bodyweights of animals were recorded.
- Necropsy of survivors performed: Yes; animals were subjected to gross necropsy. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 834 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- - No mortality was observed.
- Clinical signs:
- other: - No clinical signs were observed in animals treated with 900 mg/kg bw dose. - Hypoactivity was observed in animals within 15 minutes of dosing at 3038 mg/kg bw, and all animals were recovered after 6-22 h. - Hypoactivity, muscular weakness, laboured brea
- Gross pathology:
- - Enlarged uterine horns was observed in one female at 3038 mg/kg bw.
- No abnormalities were noted at necropsy in other animals. - Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oral LD50 Combined > 6834 mg/kg bw
- Executive summary:
In an acute oral toxicity study, 3 groups of Charles River CD® Strain rats (2/sex/dose) were administered a single oral dose of test material at 900, 3038 and 6834 mg/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
No mortality was observed. Hypoactivity was observed in animals within 15 minutes of dosing at 3038 mg/kg bw, and all animals were recovered after 6-22 h. Hypoactivity, muscular weakness, laboured breathing, lacrimation, diuresis and prostration were observed at 6834 mg/kg bw and animals recovered from clinical signs within 5 days after dosing. All animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy except enlarged uterine horn in one female at 3038 mg/kg bw dose.
Oral LD50 Combined > 6834 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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