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Diss Factsheets

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of (((1,3-phenylenebis(oxy))bis(ethane-2,1-diyl))bis(oxy))bis(ethane-2,1-diyl) bis(2-methylacrylate) and (1,3-phenylenebis(oxy))bis(propane-3,1-diyl) bis(2-methylacrylate) and 3-(3-(2-(2-(methacryloyloxy)ethoxy)ethoxy)phenoxy)propyl methacrylaterate
EC Number:
944-271-1
Cas Number:
2305048-54-6
Molecular formula:
not applicable for multi-constituent.
IUPAC Name:
Reaction mass of (((1,3-phenylenebis(oxy))bis(ethane-2,1-diyl))bis(oxy))bis(ethane-2,1-diyl) bis(2-methylacrylate) and (1,3-phenylenebis(oxy))bis(propane-3,1-diyl) bis(2-methylacrylate) and 3-(3-(2-(2-(methacryloyloxy)ethoxy)ethoxy)phenoxy)propyl methacrylaterate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Batch: 653940
- Purity, including information on contaminants, isomers, etc.: No data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: No data
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): test article solubilized in tissue culture water
- Preliminary purification step (if any): No data
- Final concentration of a dissolved solid, stock liquid or gel: No data

FORM AS APPLIED IN THE TEST: test article solubilized in tissue culture water

In vitro test system

Test system:
human skin model
Remarks:
MatTek EpiDerm™ tissues
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: No data
Justification for test system used:
Per OECD 431.
Vehicle:
other: See 'Remarks'
Remarks:
Tissue culture water
Details on test system:
SKIN DISC PREPARATION
- Procedure used: EpiDerm™ tissues, Lot No. 27144 Kit O, were received from MatTek Corporation (Ashland, MA) on
03 Oct 2017 and refrigerated at 2-8°C. Before use, tissues were incubated (37±1°C, 5±1% CO2) with
assay medium (MatTek) for a one-hour equilibration. Equilibration medium was replaced with fresh
medium before dosing.

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37C
- Temperature of post-treatment incubation (if applicable): No data

REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Following exposure to test materials, any test material remaining atop the EpiDerm™ tissues will be discarded. Each insert will be individually rinsed extensively with phosphate buffered saline (PBS) to remove residual test material. For a test article in which the tissue or assay medium undergoes a noticeable color change (due to pH change, staining of the tissue, etc.), an extra rinsing procedure will be performed before the MTT conversion. The tissues will be submerged twice in fresh PBS and then incubated in PBS at room temperature for 3 minutes.
- Observable damage in the tissue due to washing: No data
- Modifications to validated SOP: No data

DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: visible range
- Wavelength: 540 to 570 nm
- Filter: No data
- Filter bandwidth: No data

NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the mean viability at 3 min is greater than 50% or if the mean viability is less than or equal to 50% at 3 min but the mean viability at 60 min is greater than 15%.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 uL
Duration of treatment / exposure:
3 or 60 minutes
Duration of post-treatment incubation (if applicable):
None
Number of replicates:
2

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 minutes
Value:
95.5
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
not examined
Remarks on result:
other:
Remarks:
Non-corrosive
Irritation / corrosion parameter:
% tissue viability
Remarks:
60 minutes
Value:
91.9
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
not examined
Remarks on result:
other:
Remarks:
Non-corrosive
Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: None
- Colour interference with MTT: None detected

DEMONSTRATION OF TECHNICAL PROFICIENCY: The CRO running the study is techincally proficient in running OECD 439 with MatTek tissues.

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
- Range of historical values if different from the ones specified in the test guideline: Per OECD 431 and MatTek protocol.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The percent viability was 95.5% at 3 minutes and 91.9% at 60 minutes. The test article was non-corrosive. 
Executive summary:

DiBrorma was tested in a GLP-compliant, OECD 431EpiDerm™ Skin Corrosivity Test.MatTek EpiDerm™ tissues were treated in duplicate with the test article, negative control, tissue culture water, and positive control, potassium hydroxide solution, for 3 minutes and 60 minutes. Following treatment, the viability of the tissues was determined using thiazolyl blue tetrazolium bromide (MTT) uptake and conversion, and the absorbance of each tissue was measured at 540 nm. The mean viability was then expressed as a percent of control values. The percent viability was used to determine corrosivity potential. The percent viability was 95.5% at 3 minutes and 91.9% at 60 minutes. The test article was non-corrosive.