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EC number: 270-279-3 | CAS number: 68424-19-1 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid triethanol amine salt and SDA Reporting Number: 11-006-14.
- 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:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to internationally accepted test guidelines and is considered relevant, adequate and reliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine
- EC Number:
- 270-279-3
- EC Name:
- Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine
- Cas Number:
- 68424-19-1
- Molecular formula:
- Not applicable as the substance is a UVCB
- IUPAC Name:
- Fatty acids, C16-18 (even numbered) and C18-unsatd., compds. with triethanolamine.
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- paste
- Details on test material:
- - Name of test material (as cited in study report): Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine
- Physical state: Viscous, translucent yellowish waxy paste
- Analytical purity: >95%
- Impurities (identity and concentrations):See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: 01/2013
- Lot/batch No.: DDR02/91
- Expiration date of the lot/batch: October 2014
- Storage condition of test material: At +10° to +25°C
- Other: Manufacturer/Supplier: OLEON NV, Assenedestraat 2, 9940 Ertvelde, Belgium
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD/Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at dosing: Males: 7 weeks; Females: 9 weeks
- Weight at dosing: Males: 220 – 241 g; Females: 210 – 219 g
- Fasting period before study: Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus). Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. This food was offered ad libitum.
- Water (e.g. ad libitum): Drinking water was offered in bottles ad libitum.
- Acclimation period: 5 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8°C -24.8°C
- Humidity (%): 58% -64%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: March 11, 2013 To: April 3, 2013
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: sesame oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The site was situated on the animal's back between the fore and hind extremities.
- % coverage: An area of at least 5 cm x 6 cm = 10% of body surface
- Type of wrap if used: The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not necessary (no residuals)
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg bw of the mixture, correlating with 2000 mg test item/ kg bw
- Concentration (if solution): 10000 mg Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine were moistened with 5000 mg sesame oil
- Constant volume or concentration used: yes, 3000 mg/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw (limit test)
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days.
During the follow-up period (at least 2 weeks) changes in skin and fur, eyes and mucous membranes, and the respiratory, circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern were observed at least once a day until all symptoms have subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Animals found in a moribund condition and animals showing severe pain or enduring signs of severe distress were humanely killed.
Observations on deaths were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
The skin was observed for the development of erythema and oedema and was rated.
- Necropsy of survivors performed: yes. At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. No histopathology was carried out as no macroscopical findings were noted at autopsy. - Statistics:
- The LD50 could not be calculated as no animal died prematurely.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- A single dermal administration of 2000 mg test item/kg bw to rats revealed no deaths.
- Clinical signs:
- other: A single dermal administration of 2000 mg test item/kg bw to rats revealed no signs of toxicity. A very slight erythema was observed on test day 2 in all 5 of 5 male and 5 of 5 female animals.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A very slight erythema was observed on test day 2 in all 5 of 5 male and 5 of 5 female animals.
LD50 > 2000 mg/kg bw. - Executive summary:
Acute dermal toxicity was tested in rats according to Council Regulation (EC) No. 440/2008 part B.3 and OECD guideline 402. The test item Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine was moistened with sesame oil and administered at 2000 mg/kg bw.
No-effect dose level by dermal administration was > 2000 mg/kg bw. Dose level with first intolerance reactions by dermal administration was > 2000 mg/kg bw. Lowest lethal dose level by dermal administration was > 2000 mg/kg bw. There were no test item-related findings at necropsy.
Under the present test conditions, a single dermal administration of 2000 mg test item/kg bw to rats revealed no signs of toxicity and no deaths. All animals gained the expected body weight throughout the whole experimental period. A very slight erythema was observed on test day 2 in all 5 of 5 male and 5 of 5 female animals. No signs or abnormalities were noted at necropsy. LD50 > 2000 mg/kg bw.
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