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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
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
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- Auto flammability
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Endpoint summary
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- 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
Endpoint summary
Administrative data
Description of key information
Skin Corrosion: Category 1(OECD431/GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- 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) - 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
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 17.83
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- 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.
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted: 14 June 2019 (OECD, 2019)
- GLP compliance:
- yes (incl. QA statement)
- 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) - 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
- Justification for test system used:
- The assessment of skin corrosivity 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 431 makes use of reconstructed human epidermis (RhE). The test is designed to predict and classify the skin corrosivity potential of a test item by assessment of its effect on a reconstituted human epidermis, based on the experience that corrosive substances show cytotoxic effects following short-term exposure of the stratum corneum of 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)
< 35 % after 3 min exposure Corrosive • Optional sub-category 1A*
≥ 35 % after 3 min exposure AND < 35 % after 60 min exposure OR ≥ 35 % after 60 min exposure AND < 35 % after 240 min exposure Corrosive • A combination of optional Sub-categories 1B and 1C
≥ 35 % after 240 min exposure Non-Corrosive - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): Sodium chloride (NaCl) 0.9% (w/v)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL - Duration of treatment / exposure:
- 240 mins
- Duration of post-treatment incubation (if applicable):
- 3 hour
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- >= 35.12 - <= 39.46
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: Since, the color of MTT solution did not turn to either blue or purple, it was concluded that, the test item did not interact with MTT.
- Colour interference with MTT: Similarly, the water control tested did not show any coloring potential nor did it reduce the MTT.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: It is considered that the NC meets the acceptance, if the mean OD value of the 2 tissues is ≥ 0.6 and ≤ 1.5 for every exposure time.
- Acceptance criteria met for positive control: It is considered that the Positive Control (glacial Glacial acetic acid) meets the acceptance if the mean viability expressed as % of the NC, is ≤ 20%.
- Acceptance criteria met for variability between replicate measurements: the difference of viability between the two tissue replicates should not exceed 30% - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the experimental conditions above, the test item Lithium difluoro(Oxalato)borate(1-) is skin corrosive by determining the tissue viability after the 240 minute exposure.
- Executive summary:
In a in vitro skin corrosion study ( G20740) according to OECD 431 TG under GLP compliance, a three dimensional Reconstructed Human Epidermis model (Episkin) were exposed to 20 mg of Lithium difluoro(Oxalato)borate(1-) for 3, 60 and 240 minutes. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the respective treatment periods with the test item was compared to the negative control tissues.
The relative mean tissue viability obtained after 3, 60 and 240 minutes treatment duration with the test item compared to the negative control tissues was 81.87, 103.61 and 35.12 %, respectively.The positive control had a mean cell viability of 6.70 % after 240 minutes exposure. The absolute mean OD570of the negative control tissues was within the laboratory historical control data range.
Since, the tissue viability is > 35% after the 240 minute exposure, the test item Lithium difluoro(Oxalato)borate(1-) is predicted to be non-corrosive under the experimental conditions described in this report.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- 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) - Species:
- cattle
- Strain:
- other: Cornea
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source:
Local abattoir (Slaughter house), Near Frazer
town, Bengaluru.
- Number of animals:
3
- Characteristics of donor animals (e.g. age, sex, weight):
Between 3 to 4 years
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):
The bovine eyes were procured from local abattoir and transported in a jar containing Hank’s Balanced Salt Solution (HBSS) and penicillinstreptomycin (100 IU/mL & 100 μg/mL) in an ice box. The experiment was initiated within 6 hours from the collection of eyes.
- Time interval prior to initiating testing:
- Indication of any existing defects or lesions in ocular tissue samples:
none
- Indication of any antibiotics used:
penicillin-streptomycin (100 IU/mL & 100 μg/mL).
- Selection and preparation of corneas:
Post pretest examination, all eyes were dissected with approximately 2-mm to
3-mm sclera with cornea from surrounding tissue and then placed in a
container with fresh HBSS (Hank’s Balanced Salt Solution), containing
penicillin-streptomycin (100 IU/mL & 100 μg/mL).
- Quality check of the isolated corneas:
Immediately after receiving the eyes in the lab, all eyes were observed for any
evidence of vascularization, pigmentation, opacity or scratches. All fourteen
collected eyes were found to be suitable for the experiment purpose. - Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- positive control: 0.75 ml 20% w/v Imidazole
negative control: 0.75 ml undiluted distilled water
test group: 0.75 ml 20% w/v test material - Duration of treatment / exposure:
- 4 hour
- Duration of post- treatment incubation (in vitro):
- 1 hour
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
Negative control (Distilled water)
POSITIVE CONTROL USED
positive control (Imidazole)
APPLICATION DOSE AND EXPOSURE TIME
20% w/v
4 hour
TREATMENT METHOD:
closed chamber
POST-INCUBATION PERIOD:
yes. 1 hour
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
the test substances from anterior chambers were removed and washed with EMEM (with phenol red) until test material was completely removed from the corneal surface. A final wash was made with EMEM without phenol red. Both the chambers were filled with fresh EMEM (without phenol red) and final opacity was measured.
- POST-EXPOSURE INCUBATION:
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of [UV/VIS spectrophotometry / microtiter plate reader] (OD490)
- Others (e.g, pertinent visual observations, histopathology): (please specify)
After final opacity measurement, the EMEM (without phenol red) was removed from anterior chamber of each cornea holder and 1 mL of 5 mg/mL sodium fluorescein solution (in Dulbecco’s Phosphate-Buffered Saline) was added.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 171.616
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study, the negative control (Distilled water) & positive control (Imidazole) exhibited expected response as No category (IVIS score 0.825) &
Category I (IVIS score 103.584) respectively. The test item Lithium Difluoro
(Oxalato) Borate (1-) exhibited IVIS score of 171.616.
From the results, it can be concluded as the test item Lithium Difluoro
(Oxalato) Borate (1-) has severe ocular hazard potential or compound causing serious eye damage, with the BCOP test method. - Executive summary:
The evaluation of the ocular hazard potential of Lithium Difluoro (Oxalato)
Borate (1-) was carried out using the Bovine Corneal Opacity and Permeability
test. A 0.75 mL of 20% w/v in distilled water of the test item (Lithium Difluoro
(Oxalato) Borate (1-), a 0.75 mL of 20% w/v in distilled water of positive
control (Imidazole) and a 0.75 mL of negative control (Distilled water) was
applied to each cornea by means of closed chamber method. The control and
treated corneas were then subjected to the opacity and permeability
measurements.
In this study, the negative control (Distilled water) was classified as UN GHS
No Category (IVIS score 0.825) and the positive control (Imidazole) was
classified under Category 1 (IVIS score 103.584). The test item Lithium
Difluoro (Oxalato) Borate (1-) exhibited an IVIS score of 171.616 and was
classified under UN GHS “Category 1”.
From the results, it can be concluded as the test item Lithium Difluoro
(Oxalato) Borate (1-) has severe ocular hazard potential or compound causing
serious eye damage, with the BCOP test method.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
In a in vitro skin corrosion study ( G20740) according to OECD 431 TG under GLP compliance, a three dimensional Reconstructed Human Epidermis model (Episkin) were exposed to 20 mg of Lithium difluoro(Oxalato)borate(1-) for 3, 60 and 240 minutes. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after the respective treatment periods with the test item was compared to the negative control tissues.
The relative mean tissue viability obtained after 3, 60 and 240 minutes treatment duration with the test item compared to the negative control tissues was 81.87, 103.61 and 35.12 %, respectively.The positive control had a mean cell viability of 6.70 % after 240 minutes exposure. The absolute mean OD570of the negative control tissues was within the laboratory historical control data range.
Since, the tissue viability is > 35% after the 240 minute exposure, the test item Lithium difluoro(Oxalato)borate(1-) is predicted to be non-corrosive under the experimental conditions described in this report.
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.
Eye irritation:
The evaluation of the ocular hazard potential of Lithium Difluoro (Oxalato)
Borate (1-) was carried out using the Bovine Corneal Opacity and Permeability
test. A 0.75 mL of 20% w/v in distilled water of the test item (Lithium Difluoro
(Oxalato) Borate (1-), a 0.75 mL of 20% w/v in distilled water of positive
control (Imidazole) and a 0.75 mL of negative control (Distilled water) was
applied to each cornea by means of closed chamber method. The control and
treated corneas were then subjected to the opacity and permeability
measurements.
In this study, the negative control (Distilled water) was classified as UN GHS
No Category (IVIS score 0.825) and the positive control (Imidazole) was
classified under Category 1 (IVIS score 103.584). The test item Lithium
Difluoro (Oxalato) Borate (1-) exhibited an IVIS score of 171.616 and was
classified under UN GHS “Category 1”.
From the results, it can be concluded as the test item Lithium Difluoro
(Oxalato) Borate (1-) has severe ocular hazard potential or compound causing
serious eye damage, with the BCOP test method.
Justification for classification or non-classification
Based on the available information in the dossier, the substance Lithium difluoro(Oxalato)borate(1-) (CAS No.409071 -16 -5) needs to be classified for skin corrosion Category 1and Eye Damage Category 1 when considering the criteria outlined in Annex I of 1272/2008/EC.
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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.