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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Female rats acclimatisation period under laboratory condition lasted four days instead of five days. This deviation did not influence the quality or integrity of the present study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Limit test:
- yes
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:
- male/female
Administration / exposure
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
At the end of the exposure period the residual test item was removed using aqua ad injectionem. - Duration of exposure:
- The test item was held in contact with the skin throughout a 24-hour period.
- Doses:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5 Male per 2000 mg/kg body weight.
5 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 application) and on day 8 and 15
- Necropsy performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality.
- Clinical signs:
- The test item showed no signs of acute dermal toxicity and no signs of dermal irritation after a single dose application.
- Body weight:
- A slight weight loss was recorded for 4 out of 5 female animals during the first week and again a weight loss was recorded for 1 out of 5 female animals during second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot clearly be concluded.
The male animals showed weight gain during the first and the second week of 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, single dermal application of the test item TEA Trioleate to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation.
The dermal LD50 was determined to be > 2000 mg TEA Trioleate / kg body weight. - Executive summary:
LD50: > 2000 mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): no vehicle used
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Signs of systemic toxicity related to dose level used, time of onset and duration: No treatment-related effects were observed.
Effect on organs (related to dose level): No treatment-related effects were observed.
Signs of irritation: No erythema or oedema nor any other signs of irritation were observed.
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