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EC number: 251-110-2 | CAS number: 32582-32-4
- 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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- e. g. dosing 5d/week, no food consumption measurements, limited pathology
- Principles of method if other than guideline:
- Internal test protocoll which generally follows OECD 408 principles (which did not exist in 1973).
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- 2-octyldodecan-1-ol
- EC Number:
- 226-242-9
- EC Name:
- 2-octyldodecan-1-ol
- Cas Number:
- 5333-42-6
- Molecular formula:
- C20H42O
- IUPAC Name:
- 2-octyldodecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): 2-Octyldodecanol
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: not given
- Expiration date of the lot/batch: not given
- Stability under test conditions: stable
- Storage condition of test material: no specific conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mus Rattus. Brunntal
- Weight at study initiation: 153 g (m), 142 g (f)
- Housing: type III Macrolon cages with 5 animals each
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: 8d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1°C
- Humidity (%): 60 +/- 5%
- Photoperiod (hrs dark / hrs light): natural daylight cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- - Justification for use and choice of vehicle (if other than water): stable in olive oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Dose / conc.:
- 1 other: ml/kg bw
- Remarks:
- actual ingested
- No. of animals per sex per dose:
- 10 m /10 f per dose
- Control animals:
- yes, concurrent vehicle
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at termination of the study with half of the animals in the control group/dose group
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
- Body weight gain : Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination of the study
- Anaesthetic used for blood collection: No
- Animals fasted: No data
- How many animals: half of dose group and control
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at termination of the study
- Animals fasted: No data
- How many animals: half of dose group and control
URINALYSIS: Yes
- Time schedule for collection of urine: at termination of the study
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table)
HISTOPATHOLOGY: Yes (see table) - Statistics:
- Standard t-test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No clinical signs or mortality was observed.
BODY WEIGHT AND WEIGHT GAIN
There were no statistically significant differences in body weights or body weight gains between the dose and control group.
FOOD AND WATER CONSUMPTION
Food and water consumption was not recorded but was considered to be normal in all groups.
HAEMATOLOGY
There were no differences between dose and control groups in the recorded hematological parameters. All values were within the normal range for animals of this age.
CLINICAL CHEMISTRY
There were no statistically significant differences in clinical chemistry parameters between the dose and control group.
URINALYSIS
There were no statistically significant differences in urine parameters between the dose and control group.
ORGAN WEIGHTS
Organ weights were in the normal range for rats of this age. There were no statistically significant differences in organ weights between dose and control groups.
GROSS PATHOLOGY
No biologically relevant findings were observed in the control or dose animals.
HISTOPATHOLOGY: NON-NEOPLASTIC
No biologically relevant findings were reported for the organs that were histologically investigated. All individual findings were accidental and usual for rats of this age and were found in both, control and dose animals.
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 other: mL/kg bw
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There was no indication that 2-octyl dodecanol was toxic in male or female Wistar rats at the limit dose of 1 mL/kg bw.
- Executive summary:
2-Octyl dodecanol was investigated in a 13 week subchronic toxicity study in male and female Wistar rats. 1 mL/kg bw of the substance was administered by gavage or the animals received olive oil as a control (vehicle).
No clinical signs or mortality was observed. There were no statistically significant differences in body weights or body weight gains between the dose and control group. Food and water consumption was not specifically recorded but was considered to be normal by observation in all groups.
There were no differences between dose and control groups in the recorded hematological parameters. All values were within the normal range for animals of this age.
There were no statistically significant differences in clinical chemistry parameters between the dose and control group. No statistically significant differences in urine parameters between the dose and control group were observed. Organ weights were in the normal range for rats of this age. There were no statistically significant differences in organ weights between dose and control groups.
No biologically relevant macroscopical findings were observed in the control or dose animals.
No biologically relevant findings were reported for the organs that were histologically investigated. All individual findings were accidental and usual for rats of this age and were found in both, control and dose animals.
There was no indication that 2-octyl dodecanol was toxic in a 13 week subchronic study with male or female Wistar rats at the limit dose of 1 mL/kg bw.
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