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EC number: 803-919-2 | CAS number: 409071-16-5
- 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:
- 2021.01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lithium difluoro(oxalato)borate(1-)
- EC Number:
- 803-919-2
- Cas Number:
- 409071-16-5
- Molecular formula:
- C2BF2LiO4
- IUPAC Name:
- Lithium difluoro(oxalato)borate(1-)
- Test material form:
- solid: particulate/powder
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:
Provided by sponsor, Batch No.:G200810043
- Purity, including information on contaminants, isomers, etc.:
99.80%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Refrigeration (+2 to +8°C)
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Cornea
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source:
Local abattoir (Slaughter house), Near Frazer
town, Bengaluru.
- Number of animals:
3
- Characteristics of donor animals (e.g. age, sex, weight):
Between 3 to 4 years
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):
The bovine eyes were procured from local abattoir and transported in a jar containing Hank’s Balanced Salt Solution (HBSS) and penicillinstreptomycin (100 IU/mL & 100 μg/mL) in an ice box. The experiment was initiated within 6 hours from the collection of eyes.
- Time interval prior to initiating testing:
- Indication of any existing defects or lesions in ocular tissue samples:
none
- Indication of any antibiotics used:
penicillin-streptomycin (100 IU/mL & 100 μg/mL).
- Selection and preparation of corneas:
Post pretest examination, all eyes were dissected with approximately 2-mm to
3-mm sclera with cornea from surrounding tissue and then placed in a
container with fresh HBSS (Hank’s Balanced Salt Solution), containing
penicillin-streptomycin (100 IU/mL & 100 μg/mL).
- Quality check of the isolated corneas:
Immediately after receiving the eyes in the lab, all eyes were observed for any
evidence of vascularization, pigmentation, opacity or scratches. All fourteen
collected eyes were found to be suitable for the experiment purpose.
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- positive control: 0.75 ml 20% w/v Imidazole
negative control: 0.75 ml undiluted distilled water
test group: 0.75 ml 20% w/v test material - Duration of treatment / exposure:
- 4 hour
- Duration of post- treatment incubation (in vitro):
- 1 hour
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
Negative control (Distilled water)
POSITIVE CONTROL USED
positive control (Imidazole)
APPLICATION DOSE AND EXPOSURE TIME
20% w/v
4 hour
TREATMENT METHOD:
closed chamber
POST-INCUBATION PERIOD:
yes. 1 hour
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
the test substances from anterior chambers were removed and washed with EMEM (with phenol red) until test material was completely removed from the corneal surface. A final wash was made with EMEM without phenol red. Both the chambers were filled with fresh EMEM (without phenol red) and final opacity was measured.
- POST-EXPOSURE INCUBATION:
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490)
- Others (e.g, pertinent visual observations, histopathology): (please specify)
After final opacity measurement, the EMEM (without phenol red) was removed from anterior chamber of each cornea holder and 1 mL of 5 mg/mL sodium fluorescein solution (in Dulbecco’s Phosphate-Buffered Saline) was added.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 171.616
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study, the negative control (Distilled water) & positive control (Imidazole) exhibited expected response as No category (IVIS score 0.825) &
Category I (IVIS score 103.584) respectively. The test item Lithium Difluoro
(Oxalato) Borate (1-) exhibited IVIS score of 171.616.
From the results, it can be concluded as the test item Lithium Difluoro
(Oxalato) Borate (1-) has severe ocular hazard potential or compound causing serious eye damage, with the BCOP test method. - Executive summary:
The evaluation of the ocular hazard potential of Lithium Difluoro (Oxalato)
Borate (1-) was carried out using the Bovine Corneal Opacity and Permeability
test. A 0.75 mL of 20% w/v in distilled water of the test item (Lithium Difluoro
(Oxalato) Borate (1-), a 0.75 mL of 20% w/v in distilled water of positive
control (Imidazole) and a 0.75 mL of negative control (Distilled water) was
applied to each cornea by means of closed chamber method. The control and
treated corneas were then subjected to the opacity and permeability
measurements.
In this study, the negative control (Distilled water) was classified as UN GHS
No Category (IVIS score 0.825) and the positive control (Imidazole) was
classified under Category 1 (IVIS score 103.584). The test item Lithium
Difluoro (Oxalato) Borate (1-) exhibited an IVIS score of 171.616 and was
classified under UN GHS “Category 1”.
From the results, it can be concluded as the test item Lithium Difluoro
(Oxalato) Borate (1-) has severe ocular hazard potential or compound causing
serious eye damage, with the BCOP test method.
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