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EC number: 213-796-1 | CAS number: 1013-75-8
- 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
- Remarks:
- Reconstructed Human Epidermis Test Method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 3, 2016 - November 24, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- 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:
- Ethyl ethyl(phenyl)carbamate
- EC Number:
- 213-796-1
- EC Name:
- Ethyl ethyl(phenyl)carbamate
- Cas Number:
- 1013-75-8
- Molecular formula:
- C11H15NO2
- IUPAC Name:
- ethyl ethyl(phenyl)carbamate
- Test material form:
- liquid
- Details on test material:
- Colorless
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions:yes
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:NO
In vitro test system
- Test system:
- human skin model
- Remarks:
- SkinEthic RHE® model,Episkin SA, RHE/S/17
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- not specified
- Justification for test system used:
- The SkinEthic™ RHE model can be use in this study according the OECD guideline for irritation testing (OECD No. 439).
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Test item was applied as supplied.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used:Episkin SA, RHE/S/17
- Tissue batch number(s):16-RHE-122
- Delivery date: 22.11.2016
- Date of initiation of testing:22.11.2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: ROOM TEMPERATURE
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps:25 x 1 mL of DPBS
-Observable damage in the tissue due to washing:NO
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:300 μL of MTT solution at 1 mg/mL
- Incubation time:3 HOURS at temperaturwe between 36.4-37.8ºC, 5% CO2
- Spectrophotometer: ELx800 absorbance microplate reader
- Wavelength:570nm
- Linear OD range of spectrophotometer: 0- 2.0
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:Specification :O.D>0.7, Result: O.D.=1.2 (CV=4.6%)
- Barrier function:Specification: 4.0h<=ET50<=10.0h, Result:5.2h
- Morphology:Specification: Number of cell layers >=4, Result:6 cell layers
- Contamination:no
NUMBER OF REPLICATE TISSUES:3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE- no interference
PREDICTION MODEL / DECISION CRITERIA
The test item is considered to be non irritant to skin: if the viability after 42 minutes of exposure and 42 hours of post-treatment incubationis > 50%.
The test item is considered to be irritant to skin: if the tissue viability after 42 minutes of exposure and 42 hours of post-treatment incubation is ≤ 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):16 μL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):16 μL
POSITIVE CONTROL
- Amount(s) applied (volume or weight):16 μL
- Concentration : 0.5 g of SDS in a 10 mL volumetric flask qsp 10 mL of distilled water - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 41 hours and 15 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- MEAN viability
- Value:
- 1.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 1.0%
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: NO
- Colour interference with MTT:The direct interaction of MTT with the test item was checked by adding 16 μL of the test item to 300 μL of solution of MTT at 1 mg/mL. After 3 hours of incubation was observed yellow solution - no direct interference between test item and MTT.
In water: The coloration potential of the test item in water was checked by adding 16 μL of the test item to 300 μL of distilled water. A colorless solution was obtained after 3 hours of incubation between 36.4°C and 37.8°C, 5% CO2.
In isopropanol: The coloration potential of the test item in isopropanol was checked by adding 16 μL of the test item to 1.5 mL of isopropanol. A colorless solution was obtained after 2 hours of incubation at room temperature. No significant coloration appeared. Therefore the test item will not interfere with the MTT assay.
DEMONSTRATION OF TECHNICAL PROFICIENCY:YES
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: SD value of the % viability ≤ 21.3%,instead of ≤ 18% as initially scheduled. This is due to a mean optical density (OD) value of the replicate No.3 treated with the negative control, which is slightly above the maximal OD value of 1.5.
- Acceptance criteria met for positive control: SD value of the % viability ≤ 18%.
- Acceptance criteria met for variability between replicate measurements:SD value of the % viability ≤ 18%.
Any other information on results incl. tables
Treatment of the results
% viability= (OD test Item / OD negative control )* 100%
Table No.1: Results
|
SKIN |
OD |
Mean OD/disc |
Mean OD/product |
Viability % |
Mean viability % |
SD |
CRITERIA |
Negative control |
1 |
0.943 |
1.019 |
1.309 |
77.8 |
100.00 |
21.3 |
|
1.039 |
||||||||
1.075 |
||||||||
2 |
1.308 |
1.334 |
101.9 |
|||||
1.352 |
||||||||
1.343 |
||||||||
3 |
1.512 |
1.575 |
120.3 |
|||||
1.557 |
||||||||
1.657 |
||||||||
Positive control |
4 |
0.012 |
0.013 |
0.013 |
1.0 |
1.0 |
0.1 |
Irritant |
0.013 |
||||||||
0.013 |
||||||||
5 |
0.011 |
0.011 |
0.8 |
|||||
0.012 |
||||||||
0.011 |
||||||||
6 |
0.013 |
0.014 |
1.1 |
|||||
0.014 |
||||||||
0.014 |
||||||||
Test item PH-16/0550 |
15 |
0.018 |
0.018 |
0.019 |
1.4 |
1.5 |
0.2 |
Irritant |
0.019 |
||||||||
0.017 |
||||||||
16 |
0.026 |
0.023 |
1.8 |
|||||
0.027 |
||||||||
0.016 |
||||||||
17 |
0.009 |
0.017 |
1.3 |
|||||
0.014 |
||||||||
0.027 |
OD-optical density
The optical density was measured after a 1:2 dilution of the formazan extracts in isopropanol
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Positive control:-irritant, SD value ≤ 18%, test item-SD value ≤ 18%, Negative control:non irritant, OD value in the range: ≥ 0.8 and ≤ 3%, SD value 21.3% / (acceptable)
- Conclusions:
- The mean corrected percent viability of the treated tissues was 1.5%, therefore test item has to be considered as irritant to skin.
- Executive summary:
In accordance with GLP study and OECD TG 439, this study was to evaluate the possible irritating effects of the test item after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model). The test item was applied at the dose of 16 μL, to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes, followed by a rinse with 25 mL of DPBS and a 41 hours and 15 minutes post-incubation period at 37°C, 5% CO2. Then the epidermis were put in contact with MTT solution. In the same condition a positive and negative control were carried out. To ensure a good contact with epidermis, all items were recovered with a nylon mesh. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The measured OD values were used to calculate a percentage of viability. The mean corrected percent viability of the treated tissues was 1.5%, therefore test item has to be considered as irritant to skin.
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