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EC number: 939-485-7 | CAS number: 218141-16-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- January 15, 1985 - January 30, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not fully compatible with Guideline 423: 2 male and 2 female animals at each dose level, dose levels 25, 200, 2000 mg/kg, rather then 50, 300, 2000 mg/kg.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Limited reporting. - 4 dose levels, highest is exceptionally: 25, 200, 2000 and 5000 mg/kg - 4 animals: 2 M + 2 F at each dose level - animals aging 4 to 6 weeks
- GLP compliance:
- yes
- Remarks:
- audited inhouse
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-Propanamine, 3-(C12-15-alkyloxy) derivs.
- EC Number:
- 271-855-7
- EC Name:
- 1-Propanamine, 3-(C12-15-alkyloxy) derivs.
- Cas Number:
- 68610-26-4
- Reference substance name:
- C12-15-Etheramine
- IUPAC Name:
- C12-15-Etheramine
- Details on test material:
- - Name of test material (as cited in study report): Etheramine 1215
- Molecular formula (if other than submission substance): CH3(CH2)n-O-(CH2)3)-NH2 (n = 11 - 14)
- Molecular weight (if other than submission substance): no info
- Physical state: Cloudy yellow liquid
- Analytical purity: no info
- Impurities (identity and concentrations): Dobanol 25
- Composition of test material, percentage of components: 3-alkyloxy propylamine
- Purity test date: no info
- Lot/batch No.: no info
- Stability under test conditions: not determined
- Storage condition of test material: stored at ambient temperature
- Other: strongly alkaline
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague-Dawley obtained from Hacking and Churchill Limited, Huntingdon, Cambridgeshire, England
- Age at study initiation: 4 to 6 weeks of age
- Weight at study initiation: 100 to 133 g
- Fasting period before study: overnight and approximately 4 hours after dosing
- Housing: metal cages with wire mesh floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet (Scientific Feeds LAD 1 obtained from Special Diet Services Ltd., Witham, Essex, England),
ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period:minimum period of 5 days prior to the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): min 21 + max 23
- Humidity (%): average 42%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hour period
IN-LIFE DATES: From: 15 January 1985 To: 30 January 1985
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil, and the other one is unknown (supplied by Sponsor)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 concentrations tested: one as supplied bij Sponsor (unknown vehicle) and one as 25% w/v solution in distilled water
- Amount of vehicle (if gavage): no info
- Justification for choice of vehicle: no justification, but the substance is insoluble in water and soluble in acetone
- Lot/batch no. (if required): no info
- Purity: no info
MAXIMUM DOSE VOLUME APPLIED: 5.75 ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no info, just started with lowest dose level - Doses:
- Dose levels:
- 25 mg/kg
- 200 mg/kg
- 2000 mg/kg
- 5000 mg/kg - No. of animals per sex per dose:
- 2 males and 2 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations after dosing, frequently on Day 1 and on subsequent days at least twice per day. Weighing
on Days 1 (dosing), 4, 8 and 15 and at death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology (macroscopic post mortem examination) - Statistics:
- No statistics.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Remarks on result:
- other: No confidence limits
- Mortality:
- At 2000 mg/kg and 5000 mg/kg all animals died (4 males and 4 females).
- Clinical signs:
- other: - 25, 200, 2000 and 5000 mg/kg: pilo-erection, abnormal body carriage (hunched posture) and increased salivation (shortly after dosing) - 200, 2000 and 5000 mg/kg: abnormal gait (waddling), lethargy and pallor of the extremities - 2000 and 5000 mg/kg: dec
- Gross pathology:
- - Animals that died: autopsy revealed haemorrhage and congestion of the lungs and pallor of the spleen, liver and kidneys
- Terminal autopsy findings were normal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The acute lethal oral dose to rats of Etheramine C12-15 was found to be: between 200 and 2000 mg/kg bodyweight, with a LD50 cut-off of 500 mg/kgbw.
- Executive summary:
The study was performed with similarities to OECD Guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) and according to GLP standards (audited in-house).
The test material, Etheramine C12-15 was evaluated for its acute oral toxicity potential in rats when administered as gavage doses at levels of 25, 200, 2000 and 5000 mg/kg to two males and two females. Dosing started with the lowest dose. As no deaths occurred at this level within 24 hours, the next dose was given to another group, and so on. At the 2000 and 5000 mg/kg levels all animals died. Clinical signs of toxicity included pilo-erection, abnormal body carriage and increased salivation accompanied by lethargy, abnormal gait, decreased respiratory rate, pallor of the extremities and ptosis. Gross pathologic examination on the animals that died showed haemorrhage and congestion of the lungs and pallor of the spleen, liver and kidneys. Gross pathologic examination at termination revealed nothing remarkable.
The dose of at 5000 mg/kg did not seem to results to higher toxicity compared to 2000 mg/kg, as time to death was not shorter (actually longer on average.)
The etheramine is (very) corrosive. The test substance was administrated undiluted at 200, 2000 and 5000 mg/kg with 0.23, 2.3 and 5.75 ml/kg respectively. It is uncertain what would happen at 300 mg/kg when 0.35 ml/kg would be dosed, but it is expected that most of the animals would survive this.
Consequently, Etheramine C12-15 is classified for GHS as Toxicity Category 4 with LD50 cut-off of 500 mg/kgbw.
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