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EC number: 500-382-3 | CAS number: 157707-73-8
- 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 according to 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:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- EC Number:
- 500-382-3
- EC Name:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- Cas Number:
- 157707-73-8
- IUPAC Name:
- Reaction product of fatty acids, C18-unsatd., dimers, and trimers, with Amines, polyethylenepoly-, triethylenetetramine fraction and amines, polyethylenepoly-, tetraethylenepentamine fraction
- Reference substance name:
- MonoFA_DimerFA__TETA_TEPA_PAA
- IUPAC Name:
- MonoFA_DimerFA__TETA_TEPA_PAA
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MonoFA_DimerFA__TETA_TEPA_PAA- Physical state: Yellow liquid with a brown hue. - Analytical purity: 100%- Lot/batch No.: BB001148V1- Expiration date of the lot/batch: 30th June 2012- Storage condition of test material: When not in use the test article was stored in a sealed container, at room temperature in the dark.
Constituent 1
Constituent 2
Constituent 3
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: 180 - 204 g. The weight variation did not exceed ±20% of the mean weight.- Fasting period before study: Animals were fasted for a period on 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. From the day prior to dosing (Day –1), the rats were housed in groups of three. - Diet: SQC(E) Rat and Mouse Maintenance Diet No 1 was freely available until the fasting period. - Water: Mains water was provided, ad libitum, via cage-mounted water bottles.- Acclimation period: 9 - 14 daysENVIRONMENTAL 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 oilMAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw.DOSAGE PREPARATION: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. 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- 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.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per dose.
- Control animals:
- no
- Details on study design:
- Two groups of 3 females were administered 2000 mg/kg bw in a maximum dose volume of 10 mL/kg. The treatment of animals was sequential to allow sufficient time between each group to confirm the survival of the previously dosed animals.Dose levels were expressed gravimetrically and in terms of test article received (without regard to purity or active content).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.Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded immediately post-dose, 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.All animals were examined at the beginning and end of the working day throughout the acclimatisation and study periods to ensure they were in good health.Rats were weighed on Day -1 (day before dosing) and on Days 1, 4, 8 and 15.Rats were killed on day 15. The necropsy procedure included inspection of 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. No tissue preservation or histopathological assessment of tissues was undertaken.
- 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 MonoFA_DimerFA__TETA_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 informationCriteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute median lethal oral dose level of the test article, MonoFA_DimerFA__TETA_TEPA_PAA, was found to exceed 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral toxicity of MonoFA_DimerFA__TETA_TEPA_PAA when administered as a single dose by oral gavage to female HsdHan:WIST rats. The study was conducted in accordance with OECD Test Guideline 423 and Method B.1 tris of Council Regulation (EC) No 440/2008, and was compliant with GLP.
Two groups of three female fasted rats were given the test article as a single dose on Day 1 by 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. Animals were observed for 14 days following treatment and during this observation period, mortality, abnormal clinical signs and bodyweight were recorded. All animals were killed on Day 15 and subsequently underwent a full necropsy.
There were no deaths following a single oral dose of MonoFA_DimerFA__TETA_TEPA_PAA among rats dosed at 2000 mg/kg bw and no clinical signs were observed. All rats gained weight during the first and second weeks of the observation period. Macroscopic examination of these animals revealed no abnormalities.
Under the conditions of this study, the acute median lethal oral dose level of the test article, MonoFA_DimerFA__TETA_TEPA_PAA, was found to exceed 2000 mg/kg bw.
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