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EC number: 202-678-5 | CAS number: 98-53-3
- 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:
- 28 Mar - 02 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted: 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-tert-butylcyclohexanone
- EC Number:
- 202-678-5
- EC Name:
- 4-tert-butylcyclohexanone
- Cas Number:
- 98-53-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-tert-butylcyclohexan-1-one
- Details on test material:
- - Name of test material (as cited in study report): 4-tert-Butycycloheanone
- Physical state: colourless solid
- Analytical purity: 99.58%
- Lot/batch No.: CHHDKP1901
- Expiration date of the lot/batch: 18 Jan 2014
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, Horst, Germany
- Age at study initiation: 8 – 12 weeks (females)
- Weight at study initiation: 151 – 186 g (females)
- Fasting period before study: food was withdrawn from the animals between approximately 16 – 24 h before administration and 2 - 4 h after administration of the test substance.
- Housing: the animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding. Wooden blocks for the environmental enrichment were added to each cage.
- Diet: standard diet “ssniff R/N-H 10 mm (Ratten-/Mäuse-Haltungsf.) V1534-0, ssniff Spezialdiäten GmbH, 59494 Soest“, ad libitum (except during the fasting period)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION:
The test item was formulated in polyethylene glycol 400 to give a solution and the applied formulations were well mixed before administration. The test substance was heated to approximately 60 °C for formulation.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the dose level to be used as the starting dose was selected from one of four fixed levels: 5, 50, 300, and 2000 mg/kg bw. The starting dose level was supposed to be the one that was most likely to produce mortality in some of the dosed animals. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (females)
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily during the observation period. The weight gain of the animals was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, grosspathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Cut-off of the test substance in 1000 mg/kg bw
- Mortality:
- 300 mg/kg bw: 1/3 female died
2000 mg/kg bw: 2/3 female died - Clinical signs:
- other: 300 mg/kg bw: lateral position, clonical clamps, tremor, labored breathing and decreased motility 2000 mg/kg bw: decreased motility, abdominal position, spasmodic state, temporary tremor, narrowed palpebral fissure, tonical cramps, lateral position and la
- Gross pathology:
- 300 and 2000 mg/kg bw: Necropsy and histopathological examination revealed no substance-related findings.
- animals found dead: black discoloured liver and spleen and hemorrhagic lung. For details refer to Table 1 under "any other information on results"
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Acute Oral 4, H302
DSD: Xn, R22
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