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Diss Factsheets
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EC number: 944-271-1 | CAS number: -
- 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:
- 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 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
- 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
Constituent 1
- 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.
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