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EC number: 606-384-1 | CAS number: 19797-08-1
- 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:
- 26 Mar - 30 Mar 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
- Report date:
- 2018
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 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test"
- Version / remarks:
- Official Journal of the European Union No. L142, 31 May 2008
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-ethylazepan-2-one
- EC Number:
- 606-384-1
- Cas Number:
- 19797-08-1
- Molecular formula:
- C8H15NO
- IUPAC Name:
- 1-ethylazepan-2-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room tempearture, protected from light
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek Corporation, Ashland MA, USA
- Source strain:
- other: EpiDerm Skin Model (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™(EPI-200) (MatTek Corporation, Ashland MA, USA)
- Tissue batch number: 28307, kit E and F
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 ± 0.5 min exposure); 37.0 ± 1.0 °C (60 ± 5 min exposure)
- Temperature of post-treatment incubation: 37.0 ± 1.0 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissues were washed with phosphate buffered saline to remove residual test item; not further specified
- Observable damage in the tissue due to washing: not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT concentrate (5 mg/mL) diluted (1:5) with MTT diluent (1 mg/mL)
- Incubation time: 3 h
- 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 undertaking an MTT cell viability test. The determined OD (540 - 570 nm) was 1.851 ± 0.085 (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 7.24 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. None of these were 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 1 h after MTT incubation.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: single experiment
PREDICTION MODEL / DECISION CRITERIA
Step 1
- 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%.
Step 2 (for test items identified as corrosive in Step 1)
- Sub-category 1A: if the viability after 3 minutes exposure is less than 25%
- A combination of sub-categories 1B and 1C : if the viability after 3 minutes exposure is greater than or equal to 25% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 μL
POSITIVE CONTROL
- Amount applied: 50 μL
- Concentration : 8 N
NEGATIVE CONTROL
- Amount applied: 50 μL - Duration of treatment / exposure:
- 3 min and 60 ± 5 min
- Number of replicates:
- duplicates for each treatment and control group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean values of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 97
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean values of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 25
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: The test item did not show reducing capacity after 1 h incubation with MTT
- Colour interference with MTT: The test substance did not change colour, when mixed with deionised water.
ACCEPTANCE OF RESULTS:
- The mean OD of the tissue replicates treated with the negative control are within the laboratory historical control data range, i.e. ≥ 1.258.and ≤ 2.615 for every exposure time (range: 1.871 to 2.120).
- Acceptance criteria met for positive control: The mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control (6.2%).
- Acceptance criteria met for variability between replicate measurements: The Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (range: 2.7% to 15%).
Any other information on results incl. tables
Table 2. Mean absorption values
|
3-minute application |
1-hour application |
||||||||
A (OD570) |
B (OD570) |
Mean ± (OD570) |
SD |
A (OD570) |
B (OD570) |
Mean ± (OD570) |
SD |
|||
Negative control |
1.871 |
1.923 |
1.897 |
± |
0.037 |
2.120 |
2.112 |
2.116 |
± |
0.006 |
N-ethylcaprolactam |
1.918 |
1.751 |
1.834 |
± |
0.118 |
0.532 |
0.518 |
0.525 |
± |
0.010 |
Positive control |
0.212 |
0.244 |
0.228 |
± |
0.023 |
0.143 |
0.122 |
0.132 |
± |
0.015 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0414). Isopropanol was used to measure the background absorption.
Table 3. Mean tissue viability
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
N-ethylcaprolactam |
97 |
25 |
Positive control |
12 |
6.2 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- CLP: not classified
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