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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021.12-2022.2
- 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:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- We conducted this non-LLNA experiment for other regions' registration purpose. And this test was conducted previously which would not justify conducting an additional LLNA due to animal welfare.
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 vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Albino, NIH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Species : Guinea Pigs
Strain : Albino, NIH (Dunkin Hartley)
Scientific name : Cavia porcellus
Source : KCC Biolabs
Tumakuru,
Karnataka
No. of animals : Vehicle Control Group: 10 (5 Males + 5 Females)
Treatment Group: 20 (10 Males + 10 Females)
Note: Positive control data from Study No. G23413 was considered for this study and included in the report. The sensitivity and reliability check of the experimental technique was established once in six months.
For pre-study:
1 Male + 1 Female for intradermal induction
1 Male + 1 Female for topical boosting
Age : 10 to 11 weeks at intra-dermal induction
Body weight range at treatment : Males: 327.1 to 437.8 g
Females: 325.7 to 415.4 g
Identification : Guinea pig accession number. Identification of individual animals was by cage card and body markings using turmeric solution / crystal violet solution. The temporary body marking during acclimatization period was done with crystal violet.
Acclimatization : After physical examination for good health and suitability for the experiment, the animals were acclimatized for 7 days before start of the treatment. Females were nulliparous and non-pregnant. Animals were observed once daily during acclimatization period for any abnormalities.
Animals were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (13.4 to 14.3 air changes/hour). Environment: temperature 21 to 23°C relative humidity 65 to 67%, with 12 hours light and
12 hours dark cycle. The maximum and minimum temperature and relative humidity in the experimental room was recorded once daily. The relative humidity in the experimental room was calculated from dry and wet bulb temperature recordings.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 % w/v test item in Milli-Q water. A quantity of 0.01 g of test item made up to 10 mL with Milli-Q water and vortexed.
- Day(s)/duration:
- 21 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1% w/v of test item in Milli-Q
- Day(s)/duration:
- 24 hour
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5 animals / sex in the vehicle control and 10 animals / sex in the test item treated group
- Details on study design:
- Two groups (5 animals / sex in the vehicle control and 10 animals / sex in the test item treated group) were sensitized with intra-dermal injection and topical application (boosting) and then challenged by topical application. Positive control (2- Mercaptobenzothiazole) data generated in-house under study number G23413 was considered for this study.
For treatment group (G2), 0.1 mL of 1:1 mixture(v/v) of Complete Freund’s Adjuvant (FCA) in Milli-Q water was injected intra-dermally at site 1, 0.1 % w/v test item in Milli-Q water was injected at site 2 and 0.1 % w/v test item in Milli-Q water mixed with 1:1 mixture (v/v) of FCA in Milli-Q water, such that the final concentration of test item injected was same as that in site 2, was injected at site 3 for the treatment group animals. Similarly, for the vehicle control group animals (G1), 1:1 mixture of FCA & Milli-Q water was injected intra-dermally at site 1, Milli-Q water at site 2 and 1:1 mixture of vehicle (Milli-Q water) and FCA -Milli-Q water(1:1 mixture) at site 3.
On day 8, 0.1% w/v of test item in Milli-Q water was transferred on to a
filter paper (size: 2 x 4 cm) and applied on to the clipped area of skin (site of intradermal injection) by an occlusive dressing for 48 hours. Similarly, 0.5 mL of Milli-Q water was used for vehicle control group animals.
On day 22, the vehicle control and treatment group animals were challenged by transfer of 0.1% w/v of test item in Milli-Q water on to a filter paper
(size: 2 x 4 cm) and applied onto the prepared area of skin to the left flank by an occlusive dressing for 24 hours.Similarly 0.5 mL of Milli-Q water was applied on to the prepared area of skin of the right flank. The skin reaction was evaluated at 24 and 48 hours, post challenge using Magnusson and Kligman Grading Scale. - Positive control substance(s):
- yes
- Remarks:
- (2- Mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 8% w/v of test item in Milli-Q water
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 8% w/v of test item in Milli-Q water
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% w/v of test item in Milli-Q water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% w/v of test item in Milli-Q water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1% w/v of test item in Milli-Q water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1% w/v of test item in Milli-Q water
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The comparison of the skin reaction (at challenge) of the test item treated animals with those of the concurrent control and positive control group animals showed that the test item “LITHIUM DIFLUORO(OXALATO)BORATE(1-)” is considered as “Non-Sensitizer” to Guinea Pigs under the stated experimental conditions and it is “Unclassified” as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2021.
- Executive summary:
The test item, LITHIUM DIFLUORO(OXALATO)BORATE (1-) was tested for its skin sensitization potential in Guinea Pigs using Magnusson and Kligman Test.
Two groups (5 animals / sex in the vehicle control and 10 animals / sex in the test item treated group) were sensitized with intra-dermal injection and topical application (boosting) and then challenged by topical application. Positive control (2- Mercaptobenzothiazole) data generated in-house under study number G23413 was considered for this study.
For treatment group (G2), 0.1 mL of 1:1 mixture(v/v) of Complete Freund’s Adjuvant (FCA) in
On day 8, 0.1% w/v of test item in Milli-Q water was transferred on to a
filter paper (size: 2 x 4 cm) and applied on to the clipped area of skin (site of intradermal injection) by an occlusive dressing for 48 hours. Similarly, 0.5 mL of Milli-Q water was used for vehicle control group animals.On day 22, the vehicle control and treatment group animals were challenged by transfer of 0.1% w/v of test item in Milli-Q water on to a filter paper
(size: 2 x 4 cm) and applied onto the prepared area of skin to the left flank by an occlusive dressing for 24 hours.Similarly 0.5 mL of Milli-Q water was applied on to the prepared area of skin of the right flank. The skin reaction was evaluated at 24 and 48 hours, post challenge using Magnusson and Kligman Grading Scale.There were no clinical signs, pre-terminal deaths or skin reactions at 24 and 48 hours, post challenge in both vehicle control and treatment group.
In the positive control (2- Mercaptobenzothiazole) study (Stu
The comparison of the skin reaction (at challenge) of the test item treated animals with those of the concurrent control and positive control group animals showed that the test item “LITHIUM DIFLUORO(OXALATO)BORATE (1-)” is considered as “Non-Sensitizer” to Guinea Pigs under the stated experimental conditions and it is “Unclassified” as per Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 2021.
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