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EC number: 211-708-6 | CAS number: 688-84-6
- 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:
- May 15, 2017 - May 22, 2017 (experimental phase)
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted on 28 July 2015
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethylhexyl methacrylate
- EC Number:
- 211-708-6
- EC Name:
- 2-ethylhexyl methacrylate
- Cas Number:
- 688-84-6
- Molecular formula:
- C12H22O2
- IUPAC Name:
- 2-ethylhexyl methacrylate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™ - 0.38 cm2
- Tissue batch number(s): 17-EKIN-020
- Shipping date: 15 May 2017
- Delivery date: 16 May 2017
- Date of initiation of testing: 15 May 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature of post-treatment incubation: 37°C, 5% CO2 and saturated humidity
REMOVAL OF TEST MATERIAL AND CONTROLS
At the end of the exposure, each tissue was rinsed with approximately 25mL of sterile D-PBS,
filling and empting the tissue insert. The excess liquid was carefully removed and the sample
transferred in new wells pre-filled with 2mL/well of maintenance medium.
- Modifications to validated SOP: not indicated in the report
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2mL/well of MTT ready-to-use solution
- Incubation time: approximately 3 hours at 37°C, 5% CO2 and saturated humidity
- Wavelength: 595 nm
- Linear OD range of spectrophotometer: confirmed by MTT formazan calibration curve
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
Criteria Classification
Mean relative viability ≤ 50% UN GHS Category 2 or 1
Mean relative viability > 50% UN GHS No Category (for member states that do not adopt optional category 3) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL, NEGATIVE and POSITIVE CONTROL
- Amount(s) applied: 20 μL (i.e. approx. 53 µL/cm2) - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- A 42 ± 1 hour recovery period was allowed by incubation at 37°C, 5% CO2 and saturated humidity
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 95
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Viability range of three test item replicates: 84.7 - 103.3% ; standard deviation 9.4
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Colour interference with MTT: no
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
Any other information on results incl. tables
Tabulated results
Blank | Negative Control | |||||
OD | sample | OD | OD-blank | mean | Viability (%) | |
0.037 | N1-1 | 0.696 | 0.6590 | |||
0.037 | N1-2 | 0.627 | 0.5900 | 0.6245 | 98.7 | |
0.036 | N2-1 | 0.702 | 0.6650 | |||
0.037 | N2-2 | 0.673 | 0.6360 | 0.6505 | 102.8 | |
0.038 | N3-1 | 0.675 | 0.6380 | |||
0.037 | N3-2 | 0.647 | 0.6100 | 0.6240 | 98.6 | |
mean | 0.037 | 0.7 | 0.6 | 100 | ||
SD | 0.001 | 0.03 | 0.02 | 2.4 | ||
CV (%) | 1.7 | 4.3 | 2.4 | 2.4 | ||
Positive Control | ||||||
sample | OD | OD-blank | mean | Viability (%) | ||
P1-1 | 0.081 | 0.0440 | ||||
P1-2 | 0.075 | 0.0380 | 0.0410 | 6.5 | ||
P2-1 | 0.068 | 0.0310 | ||||
P2-2 | 0.065 | 0.0280 | 0.0295 | 4.7 | ||
P3-1 | 0.086 | 0.0490 | ||||
P3-2 | 0.081 | 0.0440 | 0.0465 | 7.3 | ||
mean | 0.1 | 0.04 | 6 | |||
SD | 0.01 | 0.01 | 2.4 | |||
CV (%) | 10.8 | 22.2 | 22.2 | |||
Test item | ||||||
sample | OD | OD-blank | mean | Viability (%) | ||
A1-1 | 0.653 | 0.6160 | ||||
A1-2 | 0.632 | 0.5950 | 0.6055 | 95.7 | ||
A2-1 | 0.592 | 0.5550 | ||||
A2-2 | 0.554 | 0.5170 | 0.5360 | 84.7 | ||
A3-1 | 0.710 | 0.6730 | ||||
A3-2 | 0.672 | 0.6350 | 0.6540 | 103.3 | ||
mean | 0.6 | 0.6 | 95 | |||
SD | 0.06 | 0.06 | 9.4 | |||
CV (%) | 8.8 | 9.9 | 9.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this GLP conform in vitro study according to OECD 439, the test item 2-EHMA is not irritant to the skin (UN GHS No Category).
- Executive summary:
The potential of the test item 2-EHMA to be irritant to the skin was investigated through an GLP conform in vitro skin irritation study according to OECD 439, using a commercial reconstructed human epidermis (RhE) model named EPISKIN™.
The blank, negative and positive controls gave acceptable results and the study was accepted as valid.
The mean cell viability of the test item treated tissues, after the blank subtraction, was 95%.
Based on the results obtained, the test item 2-EHMA is classified as not irritant to the skin (UN GHS No Category).
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