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EC number: 234-514-3 | CAS number: 12007-60-2
- 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
- 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- Adopted July 26th 2013
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dilithium tetraborate
- EC Number:
- 234-514-3
- EC Name:
- Dilithium tetraborate
- Cas Number:
- 12007-60-2
- Molecular formula:
- B4Li2O7
- IUPAC Name:
- dilithium tetraborate
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from young cattle were obtained from the slaughterhouse were used in this study. 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.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Since no workable suspension in physiological saline could be obtained, the test item was used as delivered and added pure on top of the corneas.
- Duration of treatment / exposure:
- The eye damage of dilithium tetraborate was tested through topical application for approximately 240 minutes
- Duration of post- treatment incubation (in vitro):
- 90 minutes
- Number of animals or in vitro replicates:
- Two identical experiments were undertaken
- Details on study design:
- The test consists of topical application of dilithium tetraborate on the epithelium of the bovine cornea for 4 hours. The non-surfactant solid test item is applied neat by direct application to the surface of the cornea. After exposure the corneas were thoroughly rinsed. The opacity of the corneas was determined directly after treatment and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Dilithium tetraborate - first experiment
- Value:
- 2.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Dilithium tetraborate - second experiment
- Value:
- -1.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Dilithium tetraborate - first experiment
- Value:
- 37
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Dilithium tetraborate - second experiment
- Value:
- 14
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Dilithium tetraborate - first experiment
- Value:
- 2.297
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Dilithium tetraborate - second experiment
- Value:
- 0.99
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The corneas treated with dilithium tetraborate showed opacity values ranging from 2.0 to 3.9 and permeability values ranging from 0.317 to 3.903. The corneas were translucent after the 240 minutes of treatment with dilithium tetraborate. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from 7.4 to 60 after 240 minutes of treatment with Dilithium tetraborate.Since the results for dilithium tetraborate were spread over 2 categories (7.4, 60 and 44, respectively), the test was inconclusive and a repeat experiment was performed. The corneas treated with dilithium tetraborate showed opacity values ranging from -1.8 to -1.0 and permeability values ranging from 0.065 to 2.642. The corneas were partly translucent after the 240 minutes of treatment with dilithium tetraborate. A pH effect of the test item was observed on the rinsing medium, the corneas were rinsed until no colour change of the medium was observed. Hence, the in vitro irritancy scores ranged from -0.8 to 39 after 240 minutes of treatment with dilithium tetraborate. Since both tests provided inconclusive results, no conclusion can be drawn for eye irritation or serious eye damage.
Any other information on results incl. tables
First experiment
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score1, 2 |
Negative control |
4.0 |
0.022 |
4.3 |
Positive control |
116 |
1.744 |
143 |
Dilithium tetraborate |
2.8 |
2.297 |
37 |
1 Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Second experiment
Treatment |
Mean Opacity |
Mean Permeability |
Mean In vitro Irritation Score1, 2 |
Negative control |
2.5 |
0.021 |
2.8 |
Positive control |
123 |
1.758 |
150 |
Dilithium tetraborate |
-1.3 |
0.990 |
14 |
1 Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Both tests (experiment 1 & 2) provided inconclusive results, and therefore no conclusion can be drawn for eye irritation or serious eye damage.
- Executive summary:
In a well conducted Bovine Corneal Opacity and Permeability Assay (BCOP), dilithium tetraborate was topically applied to the epithelium of the bovine cornea for 4 hours. The non-surfactant solid test item was applied neat by direct application to the surface of the cornea. After exposure the corneas were thoroughly rinsed. The opacity of the corneas was determined directly after treatment and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein. The mean in vitro irritancy score was 37 and 14 after 240 minutes of treatment with the test item in the first and second experiment, respectively. The results for dilithium tetraborate were spread over 2 categories in both experiments. Because both tests provided inconclusive results, no conclusion can be drawn for eye irritation or serious eye damage. A further study on rabbits was therefore conducted (van Sas, 2017).
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