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EC number: 243-606-2 | CAS number: 20217-01-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02. February - 31. May 2017
- 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [(2,4-dibromophenoxy)methyl]oxirane
- EC Number:
- 243-606-2
- EC Name:
- [(2,4-dibromophenoxy)methyl]oxirane
- Cas Number:
- 20217-01-0
- Molecular formula:
- C9H8Br2O2
- IUPAC Name:
- 2-[(2,4-dibromophenoxy)methyl]oxirane
- Reference substance name:
- 2,4-dibromophenol
- EC Number:
- 210-436-5
- EC Name:
- 2,4-dibromophenol
- Cas Number:
- 615-58-7
- Molecular formula:
- C6H4Br2O
- IUPAC Name:
- 2,4-dibromophenol
- Reference substance name:
- [(p-bromophenoxy)methyl]oxirane
- EC Number:
- 218-656-3
- EC Name:
- [(p-bromophenoxy)methyl]oxirane
- Cas Number:
- 2212-06-8
- Molecular formula:
- C9H9BrO2
- IUPAC Name:
- 2-[(4-bromophenoxy)methyl]oxirane
- Reference substance name:
- [(2,4,6-tribromophenoxy)methyl]oxirane
- EC Number:
- 226-140-4
- EC Name:
- [(2,4,6-tribromophenoxy)methyl]oxirane
- Cas Number:
- 5296-40-2
- Molecular formula:
- C9H7Br3O2
- IUPAC Name:
- 2-[(2,4,6-tribromophenoxy)methyl]oxirane
- Test material form:
- liquid
- Details on test material:
- sample used for testing,
no further details
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
CG272
- Expiration date of the lot/batch: 11. July 2018
- Purity test date: not stated
RADIOLABELLING INFORMATION (if applicable)
not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle:
direct applicabion
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: direct application
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- Specification
Commercially available EpiOcularTM kit.
The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been
cultured to form a stratified squamous epithelium similar to that found in the human cornea.
It consists of highly organized basal cells. These cells are not transformed or transfected
with genes to induce an extended life span. The EpiOcularTM tissues are cultured in
specially prepared cell culture inserts with a porous membrane through which nutrients
can pass to the cells. The tissue surface is 0.6 cm2.
Origin
EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories,
Mylnské Nivy 73, 82105 Bratislava, Slovakia.
Designation of the kit: OCL-212-EIT
Day of delivery: 21. Feb. 2017
Batch no.: 23767
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 1h
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- according to Guideline
EVALUATION
The values of the 96-plate-reader were transferred into a validated spreadsheet (Microsoft
Excel®).
Note: All calculations are performed with unrounded values. Therefore, re-calculation with
rounded values may lead to slightly different results.
Calculation
- Calculation of mean OD of the blank isopropanol (ODBlk)
- Subtraction of mean ODBlk of each value of the same experiment (corrected values)
- Calculation of mean OD of the two replicates for each tissue
- Calculation of mean OD of the two relating tissues for controls and test item
Note: Corrected OD value of negative control corresponds to 100 % viability
To calculate the relative absorbance, the following equation was used:
% viability = [OD corrected of test item / OD corrected of mean negative control] 100%
Assessment of Eye Irritation
% Viability Assessment GHS classification
> 60 % Non eye irritant No GHS category
for eye irritation
≤ 60 % Eye irritant GHS category 1 or 2
Results and discussion
In vitro
Results
- Irritation parameter:
- other: % viability
- Run / experiment:
- 1
- Value:
- >= 85.8 - <= 89.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Validity criteria and results are stated in the following table:
Criterion Demanded Found
OD of negative control > 0.8 and < 2.5 1.7
% viability of positive control < 50% of negative control 24.2%
Variation within replicates ≤ 20% 2.3% (negative control)
1.9% (positive control)
3.5% (test item)
Values for negative control and for positive control were within the range of historical data
of the test facility
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, DENACOL EX-147 is considered as
non-eye irritant in the EpiOcularTM Eye Irritation Test. - Executive summary:
One valid experiment was performed.
The test item DENACOL EX-147 was applied to a three-dimensional human cornea tissue
model in duplicate for an exposure time of 28 minutes.
50 μL of the liquid test item was applied to each tissue.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of
the tissues was evaluated by addition of MTT, which can be reduced to formazan. The
formazan production was evaluated by measuring the optical density (OD) of the resulting
solution.
Demineralised water was used as negative control and methyl acetate was used as positive
control.
The controls showed the following results: After treatment with the negative control, the
absorbance values (OD was 1.7) were within the required acceptability criterion of mean
OD > 0.8 and < 2.5. The positive control showed clear eye irritating effects, the relative
absorbance value was reduced to 24.2 % (< 50%).
Variation within tissue replicates was acceptable (≤ 20%).
After treatment with the test item, the mean value of tissue viability was 87.6 %.
This value is well above the threshold for eye irritation potential (≤ 60%).
Under the conditions of the test, DENACOL EX-147 is considered as
non-eye irritant in the EpiOcularTM Eye Irritation Test.
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