Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
2017
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

Constituent 1
Chemical structure
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

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).