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EC number: 456-990-3 | CAS number: 244761-29-3 LITHIUM-BIS(OXALATO)BORATE
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-11-02 to 2010-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 24th 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lithium bis(oxalato)borate
- EC Number:
- 456-990-3
- EC Name:
- Lithium bis(oxalato)borate
- Cas Number:
- 244761-29-3
- Molecular formula:
- C4BLiO8 (Hill Empirical Formula) C4BO8.Li (CAS Empirical Formula)
- IUPAC Name:
- boron(3+) lithium(1+) dioxalate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle´s Rabbitry, Inc., Thompsons Station, TN, USA
- Age at study initiation: ca. 4 months old (born on 2010-07-20)
- Weight at study initiation: ca. 2.7 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): PMI Rabbit Chow (Diet# 5321), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
- animal room was temperature controlled.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 83.2 mg (0.1 mL equivalent) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 (one male, two females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: washing was not done.
TYPE AND FREQUENCY OF OBSERVATIONS
Using a Mini-Maglite flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours and again on days 7, 14 and 21 postdose. The control eyes were observed at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval up to day 21. The eye was examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique. Additional signs were described.
Body weights were recorded pretest and at termination.
Observations for toxicity and pharmacological effects were recorded at each ocular observation period and mortality observations were performed daily. All animals were humanely sacrificed using CO2 following study termination.
ANALYSIS OF DATA
The primary eye irritation score for each rabbit was calculated from the weighted Draize scale.
SCORING SYSTEM: according to Draize, J.H. et al. (1944)
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 22
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 98
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 98
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 40
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 98
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 98
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 73
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 71
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- overall irritation score
- Remarks:
- sum of cornea, iris and conjunctiva score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 71
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 21 days of observation period.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Corneal opacity, iritis and conjunctival irritation, noted in 3/3 eyes, persisted to day 21.
- Other effects:
- There were no abnormal physical signs noted during the observation period. Body weight increases were normal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results of this in vivo eye irritation study on three New Zealand White rabbits, lithium bis(oxalato) borate causes irreversible effects to the eyes.
- Executive summary:
An eye irritation study has been conducted with lithium bis(oxalato)borate in accordance with OECD guideline 405. Three healthy New Zealand White rabbits, free from evidence of ocular irritation and corneal abnormalities, were dosed with lithium bis(oxalato)borate. The test article (0.1 mL equivalent (83.2 mg)) was placed into the conjunctival sac of one eye of each rabbit. The eyes were examined pretest and scored by Draize technique at 1, 24, 48 and 72 hours and again on days 7, 14 and 21 postdose. The control eyes were observed at the same time periods. Sodium fluorescein dye procedures were used at the 24 -hour observation interval up to day 21. Observations for toxicity and pharmacological effects were recorded at each ocular observation period and mortality observations were performed daily. Body weights were recorded pretest and at termination. Corneal opacity, iritis and conjunctival irritation, noted in 3/3 eyes, persisted to day 21. There were no abnormal physical signs noted during the observation period. Body weight increases were normal.
Lithium bis(oxalato)borate causes irreversible effects to the healthy eye of New Zealand White rabbits. (MB Research Laboratories, 2010)
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