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EC number: 217-044-3 | CAS number: 1729-67-5
- 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:
- 2018-12-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed to current OECD guidelines with no significant deviations and run in OECD GLP certified lab.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl 2,3-dibromopropionate
- EC Number:
- 217-044-3
- EC Name:
- Methyl 2,3-dibromopropionate
- Cas Number:
- 1729-67-5
- Molecular formula:
- C4H6Br2O2
- IUPAC Name:
- methyl 2,3-dibromopropanoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: 98%
Batch No.: 800327680
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse, where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
- Storage, temperature and transport conditions of ocular tissue:
Storage: The isolated corneas were stored in a petri dish with cMEM (Earle's Minimum Essential Medium containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum).
Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): 98% - Duration of treatment / exposure:
- 10 ± 1 minutes
- Number of animals or in vitro replicates:
- Three corneas for each treatment group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- Preparation of Corneas: The isolated corneas were mounted in a corneal holder (one cornea per holder) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 ± 1°C. The corneas were incubated for the minimum of 1 hour at 32 ± 1°C.
- Cornea Selection: After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer. Corneas that had an initial opacity reading higher than 7 were not used.
QUALITY CHECK OF THE ISOLATED CORNEAS: The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
NUMBER OF REPLICATES : Three corneas for each treatment group
NEGATIVE CONTROL USED : physiological saline
POSITIVE CONTROL USED : Ethanol
APPLICATION DOSE AND EXPOSURE TIME : 750 μL of either the negative control, positive control (Ethanol) or test item; 10 ± 1 minutes
REMOVAL OF TEST SUBSTANCE: After the incubation the control or test item was washed with MEM with phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: measured by the diminution of light passing through the cornea
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: the decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- >= -0.7 - <= 1.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
The corneas were clear after the 10 minutes of treatment with test item. No pH effect of the test item was observed on the rinsing medium.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.
- Acceptance criteria met for positive control: The mean in vitro irritancy score of the positive control (Ethanol) was 47 and was within two standard deviations of the current historical positive control mean.
Applicant's summary and conclusion
- Interpretation of results:
- other: unclassfied
- Conclusions:
- In conclusion, since the test substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
- Executive summary:
The study was performed to evaluate the eye hazard potential of the test substance in accordance with OECD Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.
The test item was applied as it is (750 μL) directly on top of the corneas for 10 minutes. After exposure the cornea was thoroughly rinsed to remove the test item and incubated for 2 hours with fresh medium followed by opacity measurement and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein.
The test conditions were adequate and that the test system functioned properly.
The test substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.1 after 10 minutes of treatment.
In conclusion, since the test substance induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
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