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EC number: 701-349-8 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 July 2017 - 27 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty Acids, C14 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C34H68N2O3
- IUPAC Name:
- Fatty Acids, C14 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C15 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C35H70N2O3
- IUPAC Name:
- Fatty Acids, C15 and C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C36H72N2O3
- IUPAC Name:
- Fatty Acids, C16 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C15 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C37H74N2O3
- IUPAC Name:
- Fatty Acids, C15 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C16 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C38H76N2O3
- IUPAC Name:
- Fatty Acids, C16 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C17 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C39H78N2O3
- IUPAC Name:
- Fatty Acids, C17 and C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Fatty Acids, C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Molecular formula:
- C40H80N2O3
- IUPAC Name:
- Fatty Acids, C18 sat., bisamides with 2-[(2-aminoethyl)amino]ethanol
- Reference substance name:
- Stearic acid
- EC Number:
- 200-313-4
- EC Name:
- Stearic acid
- Cas Number:
- 57-11-4
- Molecular formula:
- C18H36O2
- IUPAC Name:
- stearic acid
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- Molecular formula:
- C16H32O2
- IUPAC Name:
- palmitic acid
- Reference substance name:
- Myristic acid
- EC Number:
- 208-875-2
- EC Name:
- Myristic acid
- Cas Number:
- 544-63-8
- Molecular formula:
- C14H28O2
- IUPAC Name:
- myristic acid
- Reference substance name:
- 2-(2-aminoethylamino)ethanol
- EC Number:
- 203-867-5
- EC Name:
- 2-(2-aminoethylamino)ethanol
- Cas Number:
- 111-41-1
- Molecular formula:
- C4H12N2O
- IUPAC Name:
- 2-(2-aminoethylamino)ethanol
- Test material form:
- solid
- Details on test material:
- Identification: N-(2-{[C16-18 (EVEN NUMBERED) ALKANOYL]AMINO}ETHYL)-N-(2-HYDROXYETHYL)[C16-18 (EVEN NUMBERED) ALKYLAMIDE
Storage Conditions: Room temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (in the dark*)
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable - test item applied undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, applied as supplied.
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: n/a
- Final preparation of a solid: n/a
FORM AS APPLIED IN THE TEST (if different from that of starting material): n/a
OTHER SPECIFICS: n/a
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes
- Cell source:
- other: MatTek Corporation, Bratislava, Slovakia
- Source strain:
- other: N/A
- Details on animal used as source of test system:
- N/A
- Justification for test system used:
- N/A
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 25 mg (~ 39 mg/cm2 according to guideline) of the test item were applied to the tissues, wetted with 25 μL DPBS prior to application.
- Concentration (if solution): See above.
VEHICLE
- Amount(s) applied (volume or weight with unit): See above.
- Concentration (if solution): See above.
- Lot/batch no. (if required): 062717
- Purity: Not reported.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): n/a
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5 % w/v - Duration of treatment / exposure:
- 60 mins
- Duration of post-treatment incubation (if applicable):
- 42 hours and 20 minutes
- Number of replicates:
- 3
Test system
- Type of coverage:
- other: Not applicable
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 86.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 2. Results after treatment with
N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
and the controls.
Dose Group |
Tissue No. |
Absor-bance 570 nm |
Absor-bance 570 nm |
Absor-bance 570 nm |
Mean Absor-bance of 3 Wells |
Mean Absor-bance of three wells blank corrected |
Mean Absor-bance of 3 tissues after blank correction |
Rel. Absor-bance [%] Tissue 1, 2 + 3* |
Relative Standard Deviation [%] |
Mean Rel. Absorbance [%]** |
Blank |
|
0.039 |
0.038 |
0.044 |
0.040 |
0.000 |
|
|||
Negative Control |
1 |
1.396 |
1.399 |
1.398 |
1.398 |
1.357 |
1.495 |
90.8 |
8.1 |
100.0 |
2 |
1.580 |
1.593 |
1.581 |
1.584 |
1.544 |
103.3 |
||||
3 |
1.631 |
1.626 |
1.612 |
1.623 |
1.583 |
105.9 |
||||
Positive Control |
1 |
0.103 |
0.105 |
0.104 |
0.104 |
0.064 |
0.063 |
4.3 |
3.6 |
4.2 |
2 |
0.104 |
0.105 |
0.105 |
0.104 |
0.064 |
4.3 |
||||
3 |
0.100 |
0.101 |
0.100 |
0.100 |
0.060 |
4.0 |
||||
Test Item |
1 |
1.383 |
1.397 |
1.384 |
1.388 |
1.348 |
1.288 |
90.2 |
5.1 |
86.2 |
2 |
1.255 |
1.273 |
1.249 |
1.259 |
1.219 |
81.5 |
||||
3 |
1.348 |
1.327 |
1.342 |
1.339 |
1.299 |
86.9 |
OD= Optical Density
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100 %
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test substance is not considered to be irritant to the skin and does not meet the criteria for classification in accordance with UN GHS and EU CLP regulation.
- Executive summary:
OECD 439 (2017) -The skin irritation potential of
N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
was assessed using an EpiDerm Reconstructed Human Epidermis (RHE) Model Kit in accordance with OECD guidance 439 and GLP.Triplicate tissues were exposed to the test item for 60 minutes. At the end of the exposure period the test item was rinsed and the tissues incubated for a further 42 h in the presence of maintenance solution which would be used for possible inflammatory mediator determination. Each tissue was then loaded with MTT. After incubation and extraction, the solutions were aliquoted for absorbance measurements. Absorbency at 570 nm of each well was measured using a spectrophotometer.
Mean viability of tissues exposed to the test substance after 60 minutes were 86.2 %. It was considered unnecessary to perform IL-1a analysis as the results of the MTT test were unequivocal. The quality criteria required for acceptance of the results was met.
Under the conditions of this study the test substance,
N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
is not irritant to skin according to UN GHS and EU CLP regulation.
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