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Diss Factsheets
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EC number: 234-511-7 | CAS number: 12007-56-6
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 September 2017 - 20 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Principles of method if other than guideline:
- Not applicable
- 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
- Justification for test system used:
- In the interests of animal welfare, the validated in vitro skin irritation test, EPISKIN test has been conducted initially in order to minimize the need for in vivo testing.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 17-EKIN-039) is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
On the day of receipt the tissues were transferred to 12-well plates and pre-incubated with pre-warmed Maintenance Medium for approximately 22.5 hours at 37°C. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The solid test item was applied directly to the skin tissue. The skin was initially moistened with 5 µl Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test item. The amount of test item applied ranged from 14.2 mg to 22.2 mg.
- Duration of treatment / exposure:
- 15 ± 0.5 minutes at room temperature. After the exposure period, the tissues were washed with phosphate buffered saline to remove residual test item.
- Duration of post-treatment incubation (if applicable):
- The skin tissues were placed in 2 mL warmed maintenance medium until all tissues were dosed and rinsed. The skin tissues were then incubated for 42 hours at 37°C.
After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 mL MTT-solution (0.3 mg/ml in PBS) and then the tissues were incubated for a further 3 h at 37°C. - Number of replicates:
- 3 tissues per test item together with negative and positive controls.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control was determined to be 1.028 with a standard deviation of 0.052 which met the required acceptance criteria (SD<18%).
The mean relative tissue viability of the positive control was determined to be 11% with a standard deviation of 3.7 which was <50% relative to the negative control and within the Standard Deviation (SD) acceptance criteria of <18%.
The mean tissue viability for the test item was determined to be 89%. The standard deviation of the viability of the test item treated tissues was 19% which is above acceptance criteria. However, since all individual viabilities were >50%, the test outcome was considered valid.
Any other information on results incl. tables
Table
1 Mean
Absorption in the In Vitro Skin
Irritation Test with Dilithium tetraborate
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
|
SD |
|||||||
Negative control |
0.978 |
1.082 |
1.025 |
1.028 |
± |
0.052 |
|||||||
Test item |
1.076 |
0.698 |
0.962 |
0.912 |
± |
0.194 |
|||||||
Positive control |
0.090 |
0.161 |
0.102 |
0.118 |
± |
0.038 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption (0.043). Isopropanol was used to measure the background absorption.
Table
2 Mean
Tissue Viability in the In VitroSkin
Irritation Test with Dilithium
tetraborate
|
Mean tissue viability (percentage of control) |
Standard deviation (percentage) |
|||
Negative control |
100 |
5.1 |
|||
Test item |
89 |
19 |
|||
Positive control |
11 |
3.7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, an in vitro skin irritation test was conducted according to OECD 439. Dilithium tetraborate was found to be non-irritant and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.
- Executive summary:
An in vitro skin irritation test was conducted according to OECD 439. The test item was applied directly to moistened human skin for 15 minutes. After exposure, the skin was thoroughly rinsed and transferred to fresh medium. After 42 hours incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Skin irritation is expressed as the remaining cell viability after exposure to the test item. A negative and positive control were also conducted in parallel.
The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with Dilithium tetraborate compared to the negative control tissues was 89%. Since the mean relative tissue viability was above 50% after 15 ± 0.5 minutes treatment, Dilithium tetraborate was considered as non-irritant.
The positive control had a mean cell viability of 11% after 15 ± 0.5 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was < 6% for the negative and positive control, indicating that the test system functioned properly.
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