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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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:
- 2 007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: • EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.40 BIS: "In Vitro Skin Corrosion: Human Skin Model Test". Official Journal of the European Union No. L142, 31 May 2008.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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
- Specific details on test material used for the study:
- Test item storage: At room temperature
In vitro test system
- Test system:
- other: EpiDerm Skin Model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
On the day of receipt the tissues were kept on agarose and stored in the refrigerator. On the next day, at least one hour before starting the assay the tissues were transferred to 6-well plates with 0.9 ml DMEM (Dulbecco’s Modified Eagle’s Medium). The plates were incubated for approximately 2 hours at 37.0 ± 1.0ºC. The medium was replaced with fresh DMEM just before the test item was applied. The skin was moistened with 25 µl Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test item to the tissue and 34.3 to 42.0 mg of the solid test item was added into the 6-well plates on top of the skin tissues.
For the negative and positive controls, 2 tissues were treated with 50 µl Milli-Q water (negative control) and 2 tissues were treated with 50 µl 8N KOH (positive control) for both the 3-minute and 1-hour time point.
After the exposure period, the tissues were washed with phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands) to remove residual test item followed by immediate determination of the cytotoxic (corrosive) effect. The skin inserts were carefully dried. Rinsed tissues were kept in 24 well plates on 300 µl DMEM until 6 tissues (= one application time) were dosed and rinsed.
For the cell viability measurements, the DMEM was replaced by 300 µl MTT-medium and the tissues were incubated for 3 hours at 37°C in air containing 5% CO2. Following incubation, the tissues were washed with PBS and formazan and then extracted with 2 mL isopropanol (MatTek corporation) over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 570 nm in triplicate with the TECAN Infinite® M200 Pro Plate Reader.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- In the test, 34.3 to 42.0 mg of the solid test item was added directly to the top of the skin tissues. No vehicle was used. The skin was dampened with Milli-Q water prior to the test item application.
For the negative and positive controls, 2 tissues were treated with 50 µl Milli-Q water (negative control) and 2 tissues were treated with 50 µl 8N KOH (positive control) - Duration of treatment / exposure:
- Two tissues were used for a 3-minute exposure to the test item and two for a 1-hour exposure.
- Duration of post-treatment incubation (if applicable):
- After the exposure period, the tissues were washed with phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands) to remove residual test item followed by immediate determination of the cytotoxic (corrosive) effect. The DMEM was replaced by 300 µL MTT-medium and tissues were incubated for 3 hours at 37°C in air containing 5% CO2. After incubation the tissues were washed with PBS and formazan was extracted with 2 ml isopropanol (MatTek corporation) over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 570 nm in triplicate with the TECAN Infinite® M200 Pro Plate Reader.
- Number of replicates:
- The test was performed on a total of 4 tissues per test item together with a negative control and positive control. Two tissues were used for a 3-minute exposure to the test item and two for a 1-hour exposure.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute
- Value:
- 93
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- not corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 99
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- not corrosive
- Other effects / acceptance of results:
- The test item was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. Results showed that the solutions did not turn blue / purple nor a blue / purple precipitate was observed. It was therefore concluded that the test item did not interfere with the MTT endpoint.
The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 93% and 99% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit =0.8 and upper acceptance limit <2.8) and the laboratory historical control data range. The mean relative tissue viability following the 1-hour exposure to the positive control was 12%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was <17%, indicating that the test system functioned properly.
Any other information on results incl. tables
Table 1 Mean Absorption in the in vitro Skin Corrosion
Test with the test item
|
3-minute application |
1-hour application |
||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
|
Negative control |
1.773 |
1.920 |
1.847 |
0.104 |
1.958 |
1.616 |
1.787 |
0.242 |
The test item |
1.822 |
1.629 |
1.725 |
0.136 |
1.608 |
1.937 |
1.772 |
0.233 |
Positive control |
0.220 |
0.245 |
0.233 |
0.017 |
0.203 |
0.213 |
0.208 |
0.007 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
In this table the values are corrected for background absorption (0.0434). Isopropanol was used to measure the background absorption.
Table 2 Mean Tissue Viability in the in vitro Skin
Corrosion Test with the test item
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
The test item |
93 |
99 |
Positive control |
13 |
12 |
Table 3 Coefficient of Variation between Tissue
Replicates
|
3 minute |
1 hour |
Negative control |
7.7 |
17 |
The test item |
11 |
17 |
Positive control |
10 |
4.9 |
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Lithium tetraborate is not corrosive in the in vitro skin corrosion test according to OECD 431.
- Executive summary:
An in vitro skin corrosion test was conducted according to OECD 431. The test item was applied directly to moistened human skin and performed on a total of 4 tissues per test item together with a negative control and positive control. Two tissues were used for a 3-minute exposure to the test item and two for a 1-hour exposure. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 93% and 99% respectively. Because the mean relative tissue viability for the test item was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment the test item is considered to be not corrosive. In addition, the acceptance criteria was met for both the positive and negative control.
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