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EC number: 946-944-5 | 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:
- 1 October 1999 - 14 March 2002
- 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 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated
- EC Number:
- 946-944-5
- Molecular formula:
- C12H27N (C3H6O)n n=1-5, C14H31N (C3H6O)n n=1-4
- IUPAC Name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: test item provided by sponsor
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: males 8 weeks, females 9 weeks
- Weight at study initiation: 177-193g (dose range), 187-254 (main study)
- Fasting period before study: overnight
- Housing: group housing during acclimation, single housed during study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Method of randomisation in assigning animals to test and control groups : based on weight
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30 November 1999 To: 23 December 1999
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: test item is soluble in water
- Lot/batch no. (if required): 0630991047
- Purity: distilled water
- Doses:
- dose range finding study: 500, 2500, 5000 mg/ kg bw
main study: 1000, 1500, 2000 mg/ kg bw - No. of animals per sex per dose:
- dose range finding study: 1 animal/sex/dose
main study: 5 animals/ sex/ dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded 1 and 4 hours after dosing and once/ day from day 2 to 15. Body weight was recorded on days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: all surviving rats were sacrificen on day 15 and necropsis were perfomed including examination of the extermal body surface, all orifices and the thoracic, pelvic and the abdominal cavities and their contents - Statistics:
- Litchfield and Wilcoxon method for confidence limit calculation
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 308.3 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 100 - <= 1 556.1
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 212.4 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 933.9 - <= 1 574.1
- Sex:
- male
- Based on:
- test mat.
- Remarks on result:
- other: could not be determined with the statistical method used
- Mortality:
- One of 10 animals died at 1000mg/kg bw and seven of ten animals died at 1500mg/kg bw. All animals were found dead at 2000mg/kg bw by day 5.
- Clinical signs:
- other: Decreased activity, decreased body tone, abnormal gait, abnormal stance, piloerection, poor grooming, soft stools and dark areas around the nose and/or eyes were observed in all three dose levels. Dry eyes and hair loss was observed at 1000mg/kg bw with b
- Gross pathology:
- No visible lesions were observed in the surviving animals. In the animals found dead lesions of the stomach or intestines predominated. Pale intestines, mottled liver, dark liver and dark discharge from the mouth/ nose and/ or anal area were also seen.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of the study the combined LD50 for males and females is 1308.3mg/ kg bw.
- Executive summary:
The study evaluated the acute oral toxicity with a 14- day post dose observation period in Sprague Dawley rats.
In a dose ranging study the doses of 500, 2500 and 5000mg/kg bw were tested. Based on the resutls the doses selected for the main study were 1000, 1500 and 2000mg/kg bw.
Three groups of ten rats (5 males and 5 females) were administered a single oral dose. Clinical observations were recorded 1 and 4 hourse post dosing and daily from day 2 to 15. body weights were recorded on days 1, 8 and 15. Surviving animals were euthanised on day 15 and gross necropsy was perfomed.
One of 10 animals died at 1000mg/kg bw and seven of ten animals died at 1500mg/kg bw. All animals were found dead at 2000mg/kg bw by day 5.
Clinical signs included decreased activity, decreased body tone, abnormal gait, abnormal stance, piloerection, poor grooming, soft stools and dark areas around the nose and/or eyes were observed in all three dose levels. Dry eyes and hair loss was observed at 1000mg/kg bw with body quivers and right eye closure observed at 1500mg/kg bw with prostration observed at 2000mg/kg bw.
Necropsis showed in the animals found dead lesions of the stomach or intestines predominated. Pale intestines, mottled liver, dark liver and dark discharge from the mouth/ nose and/ or anal area were also seen. No lesions were observed in the animals surviving to day 15.
Based on the results of the study the combined LD50 for males and females is 1308.3mg/ kg bw (95% CL 1100- 1556.1 mg/kg bw)
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