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EC number: 701-046-0 | 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:
- 6th February 2012 to 21st June 2012.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, conducted in accordance with the relevant guidelines.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- High moecular weight adducts of Fatty acids, C16-18 sat. C18 unsat., linear, dimers, and trimers, with Amines, polyethylenepoly-, triethylenetetramine fraction
- IUPAC Name:
- High moecular weight adducts of Fatty acids, C16-18 sat. C18 unsat., linear, dimers, and trimers, with Amines, polyethylenepoly-, triethylenetetramine fraction
- Reference substance name:
- Higher molecular weight adducts of C18 Fatty acids linear (unsat & sat) with amines,polyethylenepoly-, tetraethylenepentamine fraction
- IUPAC Name:
- Higher molecular weight adducts of C18 Fatty acids linear (unsat & sat) with amines,polyethylenepoly-, tetraethylenepentamine fraction
- Reference substance name:
- Amines, polyethylenepoly-, tetraethylenepentamine fraction
- EC Number:
- 292-587-7
- EC Name:
- Amines, polyethylenepoly-, tetraethylenepentamine fraction
- Cas Number:
- 90640-66-7
- IUPAC Name:
- Amines, polyethylenepoly-, tetraethylenepentamine fraction
- Reference substance name:
- lower molecular weight adducts of C18 Fatty acids linear (unsat & sat) amines,polyethylenepoly-, tetraethylenepentamine fraction
- Molecular formula:
- for example : C26H53N5O, C26H55N5O...
- IUPAC Name:
- lower molecular weight adducts of C18 Fatty acids linear (unsat & sat) amines,polyethylenepoly-, tetraethylenepentamine fraction
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report):TOFA DimerFA TEPA PAA
- Physical state:Yellow-red, transparent, viscous liquid
- Analytical purity: 9% free amine
- Storage condition of test material:Room temperature (15°C to 30°C)
-Sponsor batch: BB000649V1
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 to 10 weeks of age.
- Weight at study initiation: The weight variation did not exceed ±20% of the mean weight.
- Fasting period before study: Animals were fasted for a period of time from the evening of the day prior to dosing until approximately 3 hours after dosing.
- Housing: The animals were housed in groups of up to five during the acclimatisation period.
- Diet: SQC(E) Rat and Mouse Maintenance Diet No 1 was freely available at all times, except during the fasting period.
- Water: Mains water was provided, ad libitum, via cage-mounted water bottles.
- Acclimation period: 9 to 14 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
Corn oil.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.
DOSAGE PREPARATION (if unusual):
Due to the viscosity of the test article, it had to be diluted in order for it to be dosed. The test article was dispersed in corn oil because the test article did not suspend in purified water. The formulated concentrations were calculated from the selected dose level and the dose volume of 10 mL/kg bw. All formulations were used within two hours of preparation.
The formulations were maintained on a magnetic stirrer prior to administration to ensure homogeneity.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Since there were no data to indicate that deaths may occur at dose levels of less than 2000 mg/kg bw, the first dose level was 2000 mg/kg bw.
Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals. - Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 3 females per group.
- Control animals:
- no
- Details on study design:
- Two groups of 3 female rats were administered 2000 mg/kg bw test material in a dose volume of 10 mL/kg bw. The treatment of the animals was sequential, with sufficient time allowed between the dosing of each group to allow time for confirmation of the survival of the previously dosed animals. Individual dose volumes (mL) were calculated using the fasted body weights of the rats on the morning of dosing (Day 1) and the dose volume of 10 mL/kg bw.
Rats were observed for clinical signs of reaction to treatment immediately post dose and at approximately 15 and 30 minutes post-dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Individual records of clinical signs were maintained for each treated rat.
Body weights were recorded on the day prior to dosing and on days 1, 4, 8 and 15.
Rats were killed day 15. Examination of all external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines was conducted. No tissue preservation or histopathological assessment of tissues was performed. - Statistics:
- Not required.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single oral dose of TOFA_DimerFA_TEPA_PAA at 2000 mg/kg bw.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No macroscopic changes were observed for animals killed on Day 15.
- Other findings:
- No other findings reported.
Any other information on results incl. tables
No additional information.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute median lethal oral dose level of the test article, TOFA_DimerFA_TEPA_PAA, was found to exceed 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of TOFA_DimerFA_TEPA_PAA was evaluated in a GLP study conducted according to OECD Test Guideline 423 and Method B.1 tris of Council Regulation (EC) No 440/2008. Two groups of three female HsdHan:WIST rats were administered a single dose of TOFA_DimerFA_TEPA_PAA via oral gavage at a dose level of 2000 mg/kg bw. The test article was dispersed in corn oil and administered at a dose volume of 10 mL/kg bw.
All test animals were observed for 14 days and clinical signs, body weight and mortality were recorded. All test animals were killed on Day 15 and subsequently underwent a full necropsy. There were no deaths following a single oral dose of TOFA_DimerFA_TEPA_PAA at 2000 mg/kg bw. There were no clinical signs. All rats gained weight during the first and second weeks of the observation period, with the exception of one animal which did not gain weight during the second week of the observation period. Macroscopic examination of these animals revealed no abnormalities. The acute median lethal oral dose level of the test article, TOFA_DimerFA_TEPA_PAA, was found to exceed 2000 mg/kg bw.
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