Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-340-6 | CAS number: 13755-29-8
- 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)
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 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
Test material
- Reference substance name:
- Sodium tetrafluoroborate
- EC Number:
- 237-340-6
- EC Name:
- Sodium tetrafluoroborate
- Cas Number:
- 13755-29-8
- Molecular formula:
- NaBF4
- IUPAC Name:
- sodium tetrafluoroborate
- Details on test material:
- - Name of test material (as cited in study report): NaBF4
- Molecular formula (if other than submission substance): NaBF4
- Molecular weight (if other than submission substance): 109.79 g/mol
- Smiles notation (if other than submission substance): [B-](F)(F)(F)F.[Na+]
- InChl (if other than submission substance): InChI=1/BF4.Na/c2-1(3,4)5;/q-1;+1
- Structural formula attached as image file (if other than submission substance): see Fig.
Constituent 1
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Negative Control: Sterile demineralised water, prepared by LAUS GmbH using an ion exchanger and mem-brane filtration through sterile filters.
Positive Control: Methyl acetate (C3H6O2, CAS No. 79-20-9), procured from MatTek - Details on study design:
- - Details of the test procedure used
- RhCE tissue construct used, including batch number
EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories, Mylnské Nivy 73, 82105 Bratislava, Slovakia.
Designation of the kit: OCL-200-EIT
Day of delivery: 23. Jan. 2018
Batch no.: 27020
- Doses of test chemical and control substances used
Tissue 1 51.0 mg
Tissue 2 51.7 mg
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
25 minutes at room temperature
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
Contains 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide (=MTT), which can be reduced to a blue formazan, prepared by LAUS GmbH.
A MTT stock solution of 5 mg/mL in DPBS buffer was prepared and stored in aliquots of 2 mL at – 20 ± 5 °C. 2 mL of the stock solution were thawed and diluted with 8 mL of as-say medium (resulting in 1 mg/mL). This MTT-solution with the concentration of 1 mg/mL was used in the test.
For the pre-test (testing the ability of direct MTT reduction), the stock solution was thawed and diluted with serum-free MEM directly before use. For the main test, the stock solution was thawed and diluted with assay medium directly before use.
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable)
The solid test item was applied to two tissue replicates
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
Criterion Demanded Found
OD of negative control > 0.8 and < 2.5 2.2
% mean relative viability of positive control <50% of negative control 37.4%
Variation within replicates < 20% 2.2% (negative control)
4.5% (positive control)
0.0% (test item)
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable because of methodological limitations
Any other information on results incl. tables
Measured Values
As blank, the optical density of isopropanol was measured in eight wells of the 96-well-plate. The measured values and their mean are given in the following table:
Table9.1‑a Absorbance Values Blank Isopropanol (OD at 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.036 |
0.037 |
0.036 |
0.039 |
0.037 |
0.038 |
0.037 |
0.038 |
0.037 |
The absorbance values of negative control, test item and positive control are given in the following table:
Table9.1‑b Absorbance Values Negative Control, Positive Control and Test Item (OD at 570 nm)
Designation |
Measurement |
Negative Control |
Positive Control |
Sodium Tetrafluoroborate |
Tissue 1 |
1 |
2.262 |
0.887 |
0.071 |
2 |
2.302 |
0.947 |
0.070 |
|
Tissue 2 |
1 |
2.219 |
0.818 |
0.071 |
2 |
2.249 |
0.815 |
0.070 |
From the measured absorbances, the mean of each tissue was calculated, subtracting the mean absorbance of isopropanol as given in table 9.1-a (= corrected values).
Table9.1‑c Mean Absorbance Negative Control, Positive Control and Test Item
Designation |
Negative Control |
Positive Control |
Sodium Tetrafluoroborate |
Mean – blank (Tissue 1) |
2.245 |
0.880 |
0.034 |
Mean – blank (Tissue 2) |
2.197 |
0.780 |
0.034 |
Comparison of Tissue Viability
For the test item and the positive control, the following percentage values of tissue viability were calculated in comparison to the negative control:
Table9.2‑a % Viability Positive Control and Test Item
Designation |
Positive Control |
Sodium Tetrafluoroborate |
% Viability (Tissue 1) |
39.6% |
1.5% |
% Viability (Tissue 2) |
35.1% |
1.5% |
% Viability Mean |
37.4% |
1.5% |
Assessment
Eye irritation is assessed using the criteria given in the following table (source: MatTek Corporation):
Table9.3‑a Assessment of Eye Irritation
% Viability |
Assessment |
UN GHS classification |
> 60 % |
Non eye irritant |
No Category |
≤60 % |
At least eye irritant |
No prediction can be made (category 1 or 2) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item was at least eye irritant. According to the OECD Guideline 492, the EpiOcularTM Eye Irritation Test does not allow discrimination between eye irritation/reversible effects on the eye (Category 2-H319) and serious eye damage/irreversible effects on the eye (Category 1-H318). Further studies have been performed according to Guideline OECD 437.
- Executive summary:
Under the conditions of the test,Sodium Tetrafluoroborate is considered either eye irritant or inducing serious eye damage in the EpiOcularTMEye Irritation Test.
After treatment with the test item, the mean value of relative tissue viability was reduced to 1.5%. This value is well below the threshold for eye irritation potential (≤ 60%).
All validity criteria were met. The criterion for optical density of the negative control was fulfilled: The OD value was 2.2 (> 0.8 and < 2.5).
The positive control induced a decrease in tissue viability as compared to the negative control to 37.4%. Variation within the replicates was acceptable (< 20%).
For these reasons, the result of the test is considered valid
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.