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EC number: 221-779-5 | CAS number: 3234-02-4
- 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:
- 2018-05-14 - 2018-06-18
- 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 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Phenylsuccinic acid
- EC Number:
- 211-238-1
- EC Name:
- Phenylsuccinic acid
- Cas Number:
- 635-51-8
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 2-phenylbutanedioic acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Molecular Formula:
HOCH2C(Br)CH2OH
Molecular Weight:
245.91
Characteristics (Physical Appearance):
White crystalline powder
CAS No.:
3234-02-4
Batch Number:
1088
Purity:
100%
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- Cell line:
SIRC (Statens Seruminstitut Rabbit Cornea) cell line.
Medium:
Minimum essential medium (MEM) supplemented with
L-glutamine containing 10% fetal bovine serum (FBS) and Penicillin Streptomycin Solution (1X).
Culture Conditions:
37 ± 1 °C, ~5% CO2, 90 to 100% Humidity.
Cell refreshing Agent:
Dulbecco’ Phosphate Buffer Saline.
Cell Dispersion Agent:
0.25% Trypsin EDTA.
Test system
- Vehicle:
- other: mineral oil
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- Test item was suspended uniformly in the mineral oil at 5% (w/w) concentration and further diluted by serial 10-fold dilution to 0.5% then to 0.05% concentration. Test item was tested at both 5% and 0.05% concentrations. Cells cultured in the 96-well plate were exposed to 200 μL/well of either a 5% or a 0.05% concentration of the test item suspension, for five minutes at room temperature.
- Duration of treatment / exposure:
- 5 minutes
- Number of animals or in vitro replicates:
- 9
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: cell viability
- Run / experiment:
- 5 %
- Value:
- 22.32
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: cell viability
- Run / experiment:
- 0.05%
- Value:
- 100.17
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: No prediction can be made
- Conclusions:
- 'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' was carried out in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 491 - Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted by the council on 09 October 2017 and as per mutually agreed Study Plan.
Under the given experimental conditions of 'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' (OECD Guideline No. 491)', it is concluded that this test method has successfully classified the test item into ‘No prediction can be made’ category as per the United Nations (UN) Globally Harmonised System (GHS) for classification of chemicals. - Executive summary:
'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' was carried out in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 491 - Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted by the council on 09 October 2017 and as per mutually agreed Study Plan.
Under the given experimental conditions of 'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' (OECD Guideline No. 491)', it is concluded that this test method has successfully classified the test item into ‘No prediction can be made’ category as per the United Nations (UN) Globally Harmonised System (GHS) for classification of chemicals.
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