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EC number: 938-702-2 | CAS number: -
- 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:
- 2012-08-10 until 2012-10-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-Cyclohexan-1-ol, dodecyl-, branched
- EC Number:
- 938-702-2
- Molecular formula:
- not applicable UVCB
- IUPAC Name:
- 4-Cyclohexan-1-ol, dodecyl-, branched
- Details on test material:
- - Name of test material (as cited in study report): Cyclohexanol, 4-C11-12-alkyl, branched
- Physical state: liquid
- Analytical purity: 97 wt. %
- Impurities (identity and concentrations): not mentioned
- 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: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: female: 149 - 179 g
- Fasting period before study: 16 - 19 h (access to water was permitted)
- Housing: in groups in IVC cages, type III H, polysulphone cages on Altromin Altromin saw fibre bedding
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice (lot no. 856)
- Water: ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: at least 5 days
The animals were non-pregnant and nulliparous.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 1. and 2. step: 0.3 g of the test item were suspended in the vehicle to gain a final volume of 10 mL and to achieve a dose of 300 mg/kg/f at a dose volume of 10 mL/kg body weight, 3. step: 1 g of the test item was suspended in the vehicle to gain a final volume of 5 mL and to achieve a dose of 2000 mg/kg body weight at a dose of 10 mL/kg body weight. For all animals of the fourth step, 1.5 g of the test item were suspended in the vehicle to gain a final volume of 7.5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 mL/kg body weight.
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characterics
- Lot/batch no. (if required): Sigma, lot MKBJ0602V, expiry date 08/2013
- Purity: not mentioned - Doses:
- 300; 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 in each of the 2 steps)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 prior to the administration and on days 8 and 15. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrified by an over-dosage of phenobarbital.
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- not performed
Results and discussion
- Preliminary study:
- not ementioned
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- none animals died
- Clinical signs:
- other: at 300 mg/kg bw/d there were no signs of toxicity, after 2 h 3 animals showed slight piloerection at 2000 mg/kg bw/d after 30 minutes there were no signs of toxicity, after 2 and 3 h slight piloerection was seen in all six animals, 3 animals showed slight
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
- Other findings:
- - Organ weights: Not reported
- Histopathology: Not reported
- Potential target organs: Not reported
- Other observations: Not reported
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No animal died. In the study performed the dosis letalis media (LD50) to rats of Cyclohexanol, 4-C11-12-alkyl, branched was found to be > 2000 mg/kg bodyweight.
- Executive summary:
The median lethal dose of Cyclohexanol, 4-C11-12-alkyl, branched after a single oral administration to female rats, observed over a perid of 14 days is LD50 > 2000 mg/kg. At a dose of 300 mg/kg bw/d after 2 h 3 animals showed slight piloerection. At 2000 mg/kg bw/d after 30 minutes there were no signs of toxicity, after 2 and 3 h slight piloerection was seen in all six animals, 3 animals showed slightly reduced spontaneous activity and bradykinesia after 4 h, after 5 hours the 3 animals showed moderately reduced spontaneous activity and moderate piloerection and d 2 until the end of the observation period no signs of toxicity were seen in all animals. None of the animals showed weight loss during the observation period.
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