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EC number: 701-204-9 | 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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study performed to a standardised guideline with sufficient detail to assess the quality of the data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- EC Number:
- 701-204-9
- Cas Number:
- 68784-17-8
- IUPAC Name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: The males were 87 days of age and the females were 94 days of age at the time of dosing.
- Weight at study initiation: The males weighed 344-393 grams, and the females weighed 215-243 grams at the time of dosing.
- Fasting period before study: yes, overnight prior to dosing
- Housing: The animals were housed individually in wire-bottom cages in an air-conditioned room.
- Diet/water (e.g. ad libitum): The animals had free access to Purina Laboratory Rodent Chow #5001 and water except during the overnight period prior to dosing when only water was available.
- Acclimation period: the animals were allowed a conditioning period of 36 days prior to dosing in the laboratory.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):23.2-23.5 °C
- Humidity (%): 57.7-64.5%
- Photoperiod (hrs dark / hrs light): The photoperiod consisted of a 12-hour light/dark cycle: lights on at 0630 and off at 1830.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Single doses of 5.0 g/kg of the undiluted test material were administered intragastrically to 5 fasted animals of each sex. Five fasted undosed animals of each sex served as controls.
- Doses:
- Single doses of 5.0 g/kg bw.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: The animals were dosed approximately 5 hours after the onset of the light cycle. They were observed frequently for any physiological or behavioral abnormalities on the day of dosing and at least once each weekday morning and late afternoon for 13 days after treatment; on weekends they were observed once daily. On Day 14, the animals were observed once prior to sacrifice.
- Frequency of observations and weighing: The animals were weighed immediately prior to dosing and at 2, 7, and 14 days after treatment. The mean body weights of the treated animals were compared to those of the respective controls using Student's t-test
- Necropsy of survivors performed: yes, all survivors were killed following the 14-day observation period were examined for gross pathological changes. The following organs and tissues were examined: skin, spleen, pancreas, esophagus, stomach, small and large intestine, liver, adrenals, kidneys, gonads, uterus or seminal vesicles, urinary bladder, heart, thymus, salivary glands, lungs, trachea, thyroid, and fat. Abnormal tissues were preserved in 10% (v/v) neutral buffered formalin and submitted for histopathological examination.
- Other examinations performed: Tissues were submitted to Histopathology Reference Laboratory, Oakland, California, for tissue processing and preparation of routine five-micron H&E stained sections. The tissue sections were evaluated for microscopic abnormalities at Chevron Environmental Health Center, Inc. - Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: One treated male was observed to have reduced food consumption 24 hours following administration. No other signs of toxicity were observed.
- Gross pathology:
- No compound-related gross or microscopic lesions were observed. Bilated dilated renal pelves in a treated male and one female were the only gross pathologic changes observed. Upon histopathological examination, moderate hydronephrosis with mild tubular regeneration was observed in the male and trace hydronephrosis was observed in the female.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 was considered to be >5 g/kg (>5000 mg/kg) based on the results.
- Executive summary:
In a study conducted broadly in line with OECD guideline 401 and in accordance with GLP, single doses of 5.0 g/kg of the undiluted test material were administered intragastrically to five fasted male and female rats. No mortality was observed. The only sign of toxicity was reduced food consumption in one treated male 24 hours following adminitration. No compound-related gross or microscopic lesions were observed.
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