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EC number: 263-218-7 | CAS number: 61792-31-2
- 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:
- weight of evidence
- Study period:
- 13 - 17 Jan 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
- EC Number:
- 263-218-7
- EC Name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
- Cas Number:
- 61792-31-2
- Molecular formula:
- C17H36N2O2
- IUPAC Name:
- N-[3-(dimethylamino)propyl]dodecanamide N-oxide
Constituent 1
- Specific details on test material used for the study:
- Freeze-dried test material was used to ensure that the purity was sufficiently high.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM reconstituted three-dimensional human epidermis (EPI-200)
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- freeze-dried test material
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200) (MatTek Corporation, Ashland, MA, USA)
- Tissue batch number: 32138
- Date of initiation of testing: 13 Jan 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min at room temperature and 60 min at 37.0 ± 1.0 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the exposure period, the tissues were washed with phosphate buffered saline to remove residual test item. The skin inserts were carefully dried. Rinsed tissues were kept in 24 well plates on 300 µL DMEM until 6 tissues (= one application time) were dosed and rinsed.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL, 1 mL/well
- Incubation time: Approx. 3 h at 37 °C
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm™ tissue was assessed by an MTT cell viability test. The determined OD (540 - 570 nm) was 1.721 ± 0.052 (acceptance criteria < 1.0 - 3.0)
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 7.67 h (acceptance criteria: 4.77-8.72 h).
- Contamination: The cells used to produce the EpiDerm™ tissue were screened for the presence of viruses, bacteria, yeast and other fungi. No contamination was detected.
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Not applicable as the test item did not show reducing capacity 60 min after MTT incubation.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: Single experiment
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test item is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50% and the viability after 1 hour exposure is less than 15%.
- The test item is considered to be non-corrosive to skin if 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%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: The skin was moistened with 25 µL Milli-Q-water and 27.1 - 35.5 mg of the solid test item were added on top of the skin tissues.
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8.0 N - Duration of treatment / exposure:
- 3 and 60 min
- Number of replicates:
- Duplicates for each treatment and control group (3 and 60 min)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 75
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: Since the test substance did not directly reduce MTT, an additional test with freeze-killed or viable tissues was not performed.
- Colour interference with MTT: Because the solutions did not turn blue / purple nor a blue / purple precipitate was observed it was concluded that the test item did not interfere with the MTT endpoint.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD 570 nm of the tissue replicates treated with the negative control was 1.677 ± 0.103 for the 3 min exposure and 1.799 ± 0.001 for the 1 h exposure and fell within the acceptance limits of OECD 431 (lower acceptance limit ≥ 0.8 and upper acceptance limit ≤ 2.8) and within the laboratory historical control data range (1.258 – 2.414 for 3 min exposure and 1.317 – 2.371 for 1 h exposure).
- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control was < 15% compared to the negative control (9.2% for 3 min exposure and 12.0% for 1 hour exposure).
- Acceptance criteria met for variability between replicate measurements: The coefficient of variation (CV) in the range 20 – 100% viability between tissue replicates for the negative control was ≤ 30% (values between 0.1 - 8.3). The CV between replicates of the test item tissues was > 30% for the 1 hour exposure. Since all individual viabilities were in the same sub-category, the test outcome was considered to be valid.
Any other information on results incl. tables
Table 1: Mean absorption data
3-minute application | 1-hour application | |||||
A (OD570) | B (OD570) | Mean ± SD | A (OD570) | B (OD570) | Mean ± SD | |
Negative control | 1.75 | 1.604 | 1.677 ± 0.103 | 1.8 | 1.798 | 1.799 ± 0.001 |
Test item | 1.583 | 1.635 | 1.609 ± 0.037 | 1.646 | 1.053 | 1.349 ± 0.419 |
Positive control | 0.248 | 0.158 | 0.203 ± 0.063 | 0.147 | 0.186 | 0.166 ± 0.028 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
Table 2: Mean tissue viability data
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
Test item |
96 |
75 |
Positive control |
12 |
9.2 |
Table 3: Coefficient of Variation between tissue replicates
|
3 minute |
1 hour |
Negative control |
8.3 |
0.1 |
Test item |
3.2 |
36 |
Positive control |
36 |
21 |
CV (%) = 100 - [(lowest OD570 / highest OD570) x 100%]
Table 4: Historical control data
|
Negative control |
Positive control |
||
3-minute treatment(OD570) |
1-hour treatment(OD570) |
3-minute treatment(OD570) |
1-hour treatment(OD570) |
|
Range |
1.258 – 2.414 |
1.317 – 2.371 |
0.083 – 0.512 |
0.070 – 0.298 |
Mean |
1.71 |
1.73 |
0.18 |
0.14 |
SD |
0.21 |
0.20 |
0.09 |
0.04 |
n |
104 |
107 |
102 |
100 |
SD = Standard deviation
n = Number of observations
The historical control data range of the controls were obtained by collecting all data over the period of Nov 2016 to Nov 2019.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive according to Regulation (EC) No. 1272/2008.
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat.1A) based on a positive result in the human epidermis model test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant and shall therefore be subject to further evaluation.
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