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EC number: 945-989-8 | 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 March to 23 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Condensation products of N-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid
- EC Number:
- 945-989-8
- IUPAC Name:
- Condensation products of N-(2-aminoethyl)octadecanamide and N-(2-aminoethyl)hexadecanamide with sebacic acid
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Kyoeisha Chemical Co., Ltd
- Lot No.of test material: 6021874
- Expiration date of the lot/batch: 18 February 2019
- Purity test date: 3 October 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (Ambient). In original container as supplied by the Sponsor. Container was kept tightly closed and away from heat or sunlight
- Stability under test conditions: Assumed stable for the duration of the study
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable, the test item was administered as supplied
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: None
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, cornea surface wetted with sterile water and test item added
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: obtained from human derived non-transformed epidermal keratinocytes
- Justification for test system used:
- This study addresses the human health endpoint skin irritation. It uses reconstructed human epidermis (RhE) (obtained from human derived non-transformed epidermal keratinocytes) which closely mimics the histological, morphological, biochemical and physiological properties of the upper parts of the human skin. The use of reconstructed human epidermis (RhE) is recommended by the OECD and other regulatory authorities. SkinEthicTM RHE model has been validated and is part of the OECD validated reference methods (VRMs) and is a recommended model for conducting in vitro skin irritation studies. The results of the study are believed to be of value in predicting the potential of inducing skin irritation by the test item in humans.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The SkinEthicTM RHE model
- Tissue batch number: 18-RHE-029
- Production date:
- Shipping date:
- Delivery date:
- Date of initiation of testing: 10 March 2018 (Experimental start)
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Incubated at room temperature for 42 minute exposure.
- Temperature of post-treatment incubation (if applicable): After washing and drying, tissues were incubated in a 6-well plate containing 2 mL growth medium at 37 ± 1°C in 5 ± 1% CO2 in a humidified incubator for 42 hours (± 60 min).
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After exposure, tissues were rinsed and then dried with cotton buds. The test item was removed by rinsing 25 times in a constant stream of DPBS at 5-8 cm distance from the insert to remove test item from the epidermal surface. Mesh (applied on negative and positive control tissues) was removed by washing. The bottom of tissue inserts were dried on a sterile absorbent paper (Kim wipes) for 1-2 seconds. The surface of the stratum corneum was gently swept up using both ends of a cotton tip (5-6 turns per end). After washing, inserts were transferred to holding plates (at room temperature) containing 300 µL maintenance medium.
- Observable damage in the tissue due to washing: None
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 180 minutes at 37 ± 1°C in 5 ± 1% CO2 in a 95% humidified incubator.
- Spectrophotometer: SynergyHT Microplate Reader
- Wavelength: 570 nm
- Filter: not specified
- Filter bandwidth: not spacified
- Linear OD range of spectrophotometer: Not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: yes, cell viability in tissues of the negative control, test item and positive control was compared against laboratory historical data.
- Barrier function: Not specified
- Morphology: obtained from human derived non-transformed epidermal keratinocytes which closely mimics the histological, morphological, biochemical and physiological properties of the upper parts of the human skin,
- Contamination: None
- Reproducibility: within acceptable parameters
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues
- Procedure used to prepare the killed tissues (if applicable):
- N. of replicates :
- Method of calculation used:
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.]
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): 16 ± 2 mg of test item/0.5 cm2
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL/0.5 cm2 sterile dulbecco’s phosphate buffered saline (DPBS)
POSITIVE CONTROL
- Amount(s) applied (volume): 16 µL/0.5 cm2 of 5% sodium dodecyl sulphate (5% aq.)
- Concentration (if solution): 5% aq - Duration of treatment / exposure:
- Incubated at room temperature for 42 minute exposure.
- Duration of post-treatment incubation (if applicable):
- After washing and drying, tissues were incubated in a 6-well plate containing 2 mL growth medium at 37 ± 1°C in 5 ± 1% CO2 in a humidified incubator for 42 hours (± 60 min).
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- One experiment
- Value:
- 100
- Negative controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- one experiment
- Value:
- 110.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- one experiment
- Value:
- 1.5
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: The test item did not produce direct MTT reduction when compared to the concurrent negative control (Maintenance medium).
- Colour interference with MTT: The results of the color interference test showed no interference in optical density due to the test item.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the classification for Reaction mass of N, N’-bis [2-(octadecanoylamino) ethyl] decanediamide and N, N’-bis [2-(hexadecanoylamino) ethyl] decanediamide is as follows:
Globally Harmonized System of Classification and : No Category (Non Skin Irritant)
Labelling of Chemicals
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