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EC number: 268-369-2 | CAS number: 68082-25-7 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid triethanol amine salt and SDA Reporting Number: 04-006-14.
- 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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
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:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- EC Number:
- 268-369-2
- EC Name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- Cas Number:
- 68082-25-7
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- Test material form:
- liquid
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item was administered at a single dose by gavage using a feeding tube.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing. - Doses:
- The test item was administered at a dose volume of 10 mL/kg body weight.
3 Female per 300 mg/kg body weight.
6 Female per 2000 mg/kg body weight. - No. of animals per sex per dose:
- 3 Female per 300 mg/kg body weight.
6 Female per 2000 mg/kg body weight. - Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: once daily
- Frequency of weighing: on day 1 (prior to the administration) and on day 8 and 15.
- Necropsy performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, mortality
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality.
- Clinical signs:
- No signs of toxicity.
- Body weight:
- None of the animals showed weight loss during the observation period.
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item TEA Trioleate to rats at a dose of 300 mg/kg body weight was associated with no signs of toxicity or mortality.
Under the conditions of the present study, a single oral application of the test item TEA Trioleate to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.
The median lethal dose of TEA Trioleate after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): ∞ mg/ kg bw - Executive summary:
One group of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 300 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.03 g/mL and administered at a dose volume of 10 mL/kg.
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended with the vehicle corn oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study without showing any test-item related signs of toxicity.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
LD50 cut-off: ∞ mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle: Corn Oil
Number of animals: 3 per step / 3 steps performed
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