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EC number: 271-547-2 | CAS number: 68585-02-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-04-13 to 2018-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 2015
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- EC Number:
- 271-547-2
- EC Name:
- Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine
- Cas Number:
- 68585-02-4
- Molecular formula:
- C28H63N5O4
- IUPAC Name:
- acetic acid;N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine;octadecanoic acid
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm
- Tissue batch number(s): 25899
- Certificate date: 2018-04-25
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: The incubation conditions were 37°C, 5% CO2 and 95% relative humidity for the first 35 minutes followed by 25 minutes at room temperature under a sterile hood.
- Temperature of post-treatment incubation (if applicable): 42 hours
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: no details
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Tecan Sunrise Magellan Version 7.2
- Wavelength: 540 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: MTT WC assay (OD 540 -570 nm) passed
- Barrier function: ET50 assy (ET50 4.77 -8.72 hrs) passed
- Morphology: passed
- Contamination: sterility an d biological contaminats tested: passed
- Reproducibility: validity criteria fullfilled
NUMBER OF REPLICATE TISSUES: 3 tissues
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Not applicable, no possible interference with the MTT measurement
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
According to the EU and GHS classification (H314 or H315 / Category 1/2 or no label), an irritant is predicted if the mean relative tissue viability of three individual tissues exposed to the test substance is reduced below or equal to 50% of the mean viability of the negative controls.
mean tissue viability ≤ 50% Irritant (I), (H314 or H315 or GHS Category 1 or 2 )
mean tissue viability > 50% non-irritant (NI). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
25 mg of test item were applied to the skin model.
The test item was grounded and applied as a fine powder.
For better contact of the test item to the skin, the skin surface was moistened with 25 µL Dulbecco’s phosphate buffered saline (D-PBS)
NEGATIVE CONTROL
D-PBS was used as the negative control.
30 µL
POSITIVE CONTROL
5% aqueous sodium dodecyl sulphate (SDS)
30 µL - Duration of treatment / exposure:
- The whole exposure period for the used EpiDermTM skin model was 60 minutes. The incubation conditions were 37°C, 5% CO2 and 95% relative humidity for the first 35 minutes followed by 25 minutes at room temperature under a sterile hood.
- Duration of post-treatment incubation (if applicable):
- Post treatment incubation period of the rinsed tissues in fresh assay medium of 42 hours
- Number of replicates:
- 3 tissues
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Test substance
- Value:
- 79.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The mean viability of cells exposed to the test item was 79.5% of the negative controls and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of > 50%.
The test substance was considered to be non-cytotoxic and predicted to be non-irritant to skin.
The mean optical density (OD) of 3 negative control tissues was 1.747 and was well within the acceptable range of ≥ 0.8 to ≤ 2.8.
The viability of cells treated with the positive reference item, 5% SDS, was 6.6% of the negative control and fulfilled the acceptance criterion of ≤ 20%.
The standard deviation (15.7%) determined for all triplicates w3as below the limit of acceptance of 18%.
Hence, all acceptance criteria were met.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions, Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine tested at an exposure time of 60 minutes and a 42-hour post-treatment incubation period, was non-cytotoxic and, hence, predicted to be non-irritant to skin in an experiment employing an artificial three-dimensional model of human skin (EpiDerm™). Hence, the test item did not show irritant properties and is therefore not classified as irritant (UN GHS no category)..
- Executive summary:
The EpiDermTM model was used to distinguishes irritants in accordance with UN GHS Category 1 or Category 2 from non-classified test substances.
Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.
Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine was applied as solid test item to the model skin surface, which was moistened with Dulbecco’s phosphate buffered saline (D-PBS). D-PBS was used as the negative control. 5% aqueous sodium dodecyl sulphate (SDS) was used as the positive reference item. An exposure time of 60 minutes was employed followed by a 42-hour post-treatment incubation period in fresh medium.
The mean viability of cells exposed to the test substance was 79.5% of the negative controls and, hence, was well above the cut-off percentage cell viability value that distinguishes irritant from non-irritant test items of > 50%.Octadecanoic acid, reaction products with acetic acid and tetraethylenepentaminewas considered to be non-cytotoxic and predicted to be non-irritant to skin.
The mean optical density (OD) of 3 negative control tissues was 1.747 and was well within the acceptable range of ≥ 0.8 to ≤ 2.8.
The viability of cells treated with the positive reference item, 5% SDS, was 6.6% of the negative control and fulfilled the acceptance criterion of ≤ 20%.
The standard deviation (15.7%) determined for all triplicates was below the limit of acceptance of 18%.
Hence, all acceptance criteria were met.
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