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EC number: 287-625-4 | CAS number: 85566-16-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (adopted March 22, 1996)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Isotridecan-1-ol
- EC Number:
- 248-469-2
- EC Name:
- Isotridecan-1-ol
- Cas Number:
- 27458-92-0
- Molecular formula:
- C13H28O
- IUPAC Name:
- Isotridecanol (reaction product of dodecene)
Constituent 1
- Specific details on test material used for the study:
- - Name of test substance: Tridecanol N
- Degree of purity: 99.9 %
- Physical state / appearance: Liquid / colorless-clear
- Lot/batch No.: continuous production
- Homogeneity: Homogeneous by visual inspection
- Storage conditions: Room temperature, covered with N2
- Stability under test conditions: The stability of the test substance in the vehicle for a time period of 4 hours was confirmed by analysis.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 - 12 weeks, female animals approx. 14 - 18 weeks)
- Weight at study initiation: mean(males): 221 g; mean(females): 211 g
- Fasting period before study: yes (Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.)
- Housing: Single housing
- Diet: Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: Acclimatization for at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: olive oil Ph.Eur./DAB
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40 g/100 ml
- Justification for choice of vehicle: Inhomogeneous in aqueous formulation, solution in olive oil Ph.Eur/DAB.
MAXIMUM DOSE VOLUME APPLIED: 5 ml /kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2000 mg/kg body weight (limit test) has been chosen in the first step with 3 female animals. As none of those animals died, 2000 mg/kg body weight were administered to 3 male animals in a second step. Because no mortality occurred either the study fulfilled the criteria for a limit test and was terminated. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 male and 3 female animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: at least 14 days
- Frequency of observations and weighing:
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
Signs and symptoms: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals;
Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes (Necropsy with gross-pathology examination on the last day of the observation period after killing with C02.)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: - Male animal symptoms: sign of toxicity noted in the 2000 mg/kg administration group was piloerection and was observed on hour 5 after administration. - Female animal symptoms: no signs of toxicity were observed during clinical examination in the 2000 mg
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (3 males and 3 females) examined at termination of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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