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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- 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)
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiSkin
- Source species:
- other: a three dimensional Reconstructed Human Epidermis model
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: cultured on a collagen matrix at the air liquid interface
- Details on animal used as source of test system:
- SkinEthic Laboratories
4, rue Alexander Fleming - 69366
Lyon, Cedex 07
France
The EpiSkin kit is produced by SkinEthic and sourced through a local supplier. - Justification for test system used:
- The assessment of skin irritation has typically involved the use of laboratory animals (OECD TG 404). In relation to animal welfare concerns, TG 404 recommends the use of a tiered testing strategy for the determination of skin corrosion and irritation which includes the use of validated in vitro or ex vivo test methods avoiding pain and suffering of animals.
One of the validated in vitro test methods adopted by the OECD TG 439 makes use of reconstructed human epidermis (RhE) which closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:
at room temperature
- Temperature of post-treatment incubation (if applicable):
37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
After the respective incubation periods, at room temperature, the epidermis units were removed from the wells and thoroughly rinsed with PBS placed on an absorbent paper to remove excess PBS. The epidermis units were then placed in a 12-well plate filled with 2 mL pre-warmed assay medium to rinse.
After rinsing, each of these epidermal units was gently tapped on an absorbent paper to remove excess assay medium.
DYE BINDING METHOD
- Dye used in the dye-binding assay: [ MTT ]
- Spectrophotometer:
Microplate reader Flex Station
- Wavelength:
570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
Mean tissue viability % is ≤ 50 % Category 2 or Category 1
Mean tissue viability % is > 50 % Non-Irritant - Control samples:
- yes, concurrent negative control
- yes, concurrent no treatment
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg
- Concentration (if solution):
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL PBS
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 μL Sodium Dodecyl Sulfate
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 4 hour
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 17.83
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The mean relative tissue viability for the test item, Lithium difluoro(Oxalato)borate(1-) was 17.83 % and hence, it is predicted to be irritant under the experimental conditions described in this report.
- Executive summary:
The test item, Lithium difluoro(Oxalato)borate(1-) was tested for its possible skin irritation potential using a three-dimensional Reconstructed Human Epidermis model, EpiSkin, through topical application for 15 minutes.
The test item is a powder and after moistening with 5 µL of water on the top of the skin tissues at 10 mg/tissue and exposed for 15 minutes.
Ten microliters (10 µL) of PBS and 10 µL of 5% aqueous SDS were used as the negative and positive controls, respectively.
After 4-hour post-incubation period, irritation potential of Lithium difluoro(Oxalato)borate(1-) was evaluated by assessing the reduction of cell viability after exposure to the test item. Cell viability was measured by determining mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.The relative mean tissue viability obtained after 15 minutes treatment with the test item was compared to the negative control tissues.
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was 0.827. The positive control had a mean cell viability of 4.88 % after 15 minutes exposure, indicating that the test system functioned properly.
The study indicated that the test item as the percent viability was 17.83 %, in this In Vitro Skin Irritation Test using Reconstructed Human Epidermis under the conditions of testing employed.
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