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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
Endpoint summary
Administrative data
Description of key information
In the acute oral toxicity study (up-and-down procedure) of lithium bis(oxalato)borate a LD50 of 550 mg/kg bw could be derived.
Under the experimental conditions adopted, the application of lithium bis(oxalato)borate for 24 h to the skin of male/female Wistar rats does not cause mortality up to a concentration of 2000 mg/kg bw.
The acute inhalation LC50 was estimated to be more than (5220.8 ± 304.6) mg/m³ in both male and female rats. Based on the results, the test substance was classified as “practical non-toxic” by acute inhalation route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-17 to 2010-02-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- October 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- April 29, 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 203-229 g
- Fasting period before study: food but not water was withheld for 24h before treatment
- Housing: 1 animal/cage (Type II. polypropylene/polycarbonate)
- Diet (e.g. ad libitum): ssniff SM R/M-Z+H, ad libitum
- Water (e.g. ad libitum): tap water from municipal supply, ad libitum
- Acclimation period: at least 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4-24.7
- Humidity (%): 38-67%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 17.5, 55, 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): 058K0070 - Doses:
- 175, 550, 2000 mg/kg bw
- No. of animals per sex per dose:
- treatment group 1 (175 mg/kg bw): 2 females
treatment group 2 (550 mg/kg bw): 4 females
treatment group 3 (2000 mg/kg bw): 1 female - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were done daily
- Necropsy of survivors performed: yes
- clinical signs: were observed 30 min, 1, 2, 3, 4 and 6 hours after treatment and once each day for 14 days thereafter
- body weight: were recorded on days -1, 0 (day of experiment), and on days 7 and 14 - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 88.94 - 2 430
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 175 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Treatment group 1: 175 mg/kg bw
No mortality occurred in this group.
Treatment group 2: 550 mg/kg bw
Treatment with lithium bis(oxalato)borate (LiBOB) at a dose level of 550 mg/kg bw caused mortality in case of 2 animals (2/3).
One female died died shortly after treatment due to a dosing accident (misgavage) and/or gastro-esophageal reflux (not test item related).
Treatment group 3: 2000 mg/kg bw
Treatment with lithium bis(oxalato)borate (LiBOB) at a dose level of 2000 mg/kg bw caused mortality in this dose group. - Clinical signs:
- other: In Treatment group 1 LiBOB caused decreased activity in one out of two rats. In Treatment group 2 a decreased activity in one out of 4 rats was observed.
- Gross pathology:
- Treatment group 1: 175 mg/kg bw
Treatment with lithium bis(oxalato)borate (LiBOB) at a dose level of 175 mg/kg bw caused dilatation, (pelvis, right) and white cloudy fluid in one rat’s kidneys in this dose group.
Treatment group 2: 550 mg/kg bw
Treatment with lithium bis(oxalato)borate (LiBOB) at a dose level of 550 mg/kg bw caused diffuse dark red discoloration of the lungs and liver, dark, punctuate red discoloration of the thymus (bilateral) and dark, red, diffuse discoloration and mucosa in ileum in this dose group.
Treatment group 3: 2000 mg/kg bw
Treatment with lithium bis(oxalato)borate (LiBOB) at a dose level of 2000 mg/kg bw caused diffuse dark red discoloration of the liver and dark, red, diffuse discoloration and mucosa in ileum, duodenum and jejunum in this dose group. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Lithium bis(oxalato)borate (LiBOB) was ranked into Category 4 of Globally Harmonized Classification System as the estimated LD50 is between 300 and 2000 mg/kg bw.
- Executive summary:
An acute oral toxicity study (up-and-down procedure) was performed with lithium bis(oxalato)borate (LiBOB) according to OECD Guideline 425. 7 young female CRL:(WI) BR Wistar rats were treated with the test item by oral gavage at dose levels of 175, 550 and 2000 mg/kg bw in corn oil. The concentrations of the formulations in corn oil were 200, 55 and 17.5 mg/mL with a constant treatment volume of 10 mL/kg bw.
Lithium bis(oxalato)borate (LiBOB) caused 100% mortality at 2000 mg/kg bw (1/1 animal) and 67% (2/3 animals) mortality at 550 mg/kg bw. There was no mortality at 175 mg/kg bw.
Treatment with lithium bis(oxalato)borate (LiBOB) caused mortality at a dose level of 2000 mg/kg bw, decreased activity (1/3) and mortality (2/3) at 550 mg/kg bw and decreased activity (1/2) at 175 mg/kg bw.
The body weight gain of the animals was considered to be normal with no indication of test item related effect.
The macroscopic examination revealed some minor alterations including diffuse dark red discoloration of the lungs (1/6) and liver (3/6), dark, punctuate red discoloration of the thymus (bilateral) (1/6), dark, red, discoloration, diffuse, mucosa in ileum (2/6), duodenum, jejunum (1/6). Dilatation, (pelvis, right) and white cloudy fluid was found in one rat’s kidneys.
The study was marked reliable without restrictions and LD50 and LD0 values of 550 and 175 mg/kg bw respectively were derived. (LAB, 2010)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 550 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-08-10 to 2010-09-10
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- This test was performed according to “the Guidelines for the Testing of Chemicals: Test No. 403: Acute Inhalation Toxicity test (Ministry of Environmental Protection of the People’s Republic of China, 2004)”, the Guidelines for the Hazard Evaluation of New Chemical Substances (Ministry of Environmental Protection ofthe People’s Republic of China, 2004) and Technical Rules on Toxicity Testing of Chemicals (Ministry of Health of the People’s Republic of China,2005).
- GLP compliance:
- no
- Remarks:
- The study was performed in China for non-Reach purposes.
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sprague – Dawley(SD) rat
- Sexes: 5 females (nulliparous and non-pregnant) and 5 males were selected for testing
- Acclimatization Period: 7 days
- Weight at study initiation: 180 – 220 g, not exceed±20 per cent of the mean weight
- Cage Type: Suspended, wire bottom, stainless steel
- Housing: 5 per cage by sex
- Diet (e.g. ad libitum): Conventional laboratory diets provided by Zhejiang Center of Laboratory Animals; available ad libitum
- Water (e.g. ad libitum): Tap water by aseptic filtration; available ad libitum from bottled water, which is changed every day.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature Range 22°C±3°C
- Humidity (%): Humidity Range 30-70%
- Air changes (per hr): 10 to 12 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 – hour light/dark cycle - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- other: Oronasal
- Vehicle:
- other: Conditioned with activated charcoal, filtered, and temperature and humidity-controlled
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Hope-Med 8051C dynamic inhalation system (produced by Tianjing Hope Industry & Trade Co., Ltd.)
- Exposure chamber volume: 300 liters
- Source and rate of air: Conditioned with activated charcoal, filtered, and temperature and humidity-controlled.
- System of generating particulates/aerosols: Device for generating particles to form aerosol:
- Treatment of exhaust air: Treated by device for exhaust air
- Temperature, humidity, pressure in air chamber: Temperature:22±3℃, relative humidity:30-70%, Slight negative pressure about -50 Pa
TEST ATMOSPHERE
- Brief description of analytical method used:
- Samples taken from breathing zone: yes
- Particle size distribution: Particle size distribution and the actual concentration of the test substance in test breathing zone were analyzed during exposure period. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- A limit test of 5000 mg/m3 was anticipated.
- No. of animals per sex per dose:
- 5 animals per sex and dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: All study animals, were subjected to gross necropsy and all abnormalities were recorded. Observations included lungs, heart , liver, spleen, kidney, stomach, intestines, etc. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 220.8 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No death occurred at the concentration of (5220.8 ± 304.6) mg/ m3.
- Clinical signs:
- other: No detectable clinical signs occurred in any test animals at 5000 mg/ m3 which could be suspected to be due to the test substance.
- Body weight:
- Individual body weights prior to exposure and on days 7.14 were measured.
- Gross pathology:
- The gross necropsy on animals of the study revealed no observable abnormalities.
- Interpretation of results:
- other: practically non-toxic according to EU GHS criteria
- Conclusions:
- The acute inhalation LC50 was estimated to be more than 5220.8 (± 304.6) mg/m³ in both male and female rats. Based on the results, the test
substance was classified as “practical non-toxic” by acute inhalation route. - Executive summary:
The test substance, LiBOB was evaluated for its acute inhalation toxicity potential when administered to SD rats. The acute inhalation LC50 was estimated to be more than 5220.8( ± 304.6) mg/m³ in both male and female rats. Based on the results, the test substance was classified as “practical non-toxic” by acute inhalation route. The test was performed according to “the Guidelines for the Testing of Chemicals: Test No. 403: Acute Inhalation Toxicity test” (Ministry of Environmental Protection of the People’s Republic of China, 2004)”, the Guidelines for the Hazard Evaluation of New Chemical Substances (Ministry of Environmental Protection of the People’s Republic of China, 2004) and Technical Rules on Toxicity Testing of Chemicals (Ministry of Health of the People’s Republic of China, 2005).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 220.8 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-09-22 to 2011-10-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Crl(WI)Br
- Hygienic level: SPF at arrival
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Weight at study initiation: preliminary study 202-222g; main study, male: 279-293g; main study, female: 214-258g
- Housing: during acclimatisation: 3 animals/sex/cage; during study: individually housed
- Diet (e.g. ad libitum): ssniff® SM R/M-Z+H complete diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: preliminary study: 5 days; main study: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of the animal
- % coverage: approximately 10 %
- Type of wrap if used: plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with body temperature water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- preliminary study: 5, 50, 300, 2000 mg/kg bw
main study: 2000 mg/kg bw - No. of animals per sex per dose:
- preliminary study: 2 female animals/dose
main study: 5 per sex/dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations twice daily; body weight was recorded on day 0 (shortly before treatment), 7 and 15
- Necropsy of survivors performed: yes
- Clinical observations: were done individually 1h and 5 h after dosing and once each day for 14 days thereafter
- Pathology: all animals were exsanguinated after 14 days and subjected to gross pathology - Preliminary study:
- There were no deaths in the preliminary study at 5, 50, 300 and 2000 mg/kg bw dose levels.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred after the 24-hour dermal exposure to lithium bis(oxalato)borate (LiBOB) in Crl:(WI)BR male and female rats during the study.
- Clinical signs:
- other: General symptoms In males treated with the 2000 mg/kg bw dose porphyrin excretion around the eyes (4 cases of 80 observations) was observed. It was detected on the treatment day between 1 and 5 hours after the treatment. But all animals were free of symp
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 15. No macroscopic alterations due to the systemic toxic effects of the test item were found.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted, the application of lithium bis(oxalato)borate (LiBOB) for 24 hours to the skin of male/female Wistar rats does not cause mortality.
- Executive summary:
An acute dermal toxicity study was performed with test item lithium bis(oxalato)borate (LiBOB) in Crl:(WI)BR rats, in compliance with OECD Guideline No.: 402, Directive 92/69 EEC B.3 and OPPTS 870.1200. A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to lithium bis(oxalato)borate (LiBOB) at 2000 mg/kg bw by dermal route. The test item was applied in original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight erythema and other signs (wounds, crusting and desquamation) between Day 1 and Day 10. Slight body weight loss was observed in three females on the first week. It could not be evaluated as a toxic effect of the test item. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. Under the experimental conditions, the acute dermal LD50 value of the test item lithium bis(oxalato)borate (LiBOB) proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. On the other hand, it is to be noted that the test item caused dermal irritation response on the site of administration. (TOXI-COOP, 2011)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
acute oral toxicity
Two studies for acute oral toxicity have been conducted in order to assess the toxic effects after oral uptake. An acute toxic class test from 2004 and an acute toxicity test using the up and down procedure of 2012.
The acute oral toxicity study (up-and-down procedure) was performed with lithium bis(oxalato)borate (LiBOB) according to OECD Guideline 425. 7 young female CRL:(WI) BR Wistar rats were treated with the test item by oral gavage at dose levels of 175, 550 and 2000 mg/kg bw in corn oil. The concentrations of the formulations in corn oil were 200, 55 and 17.5 mg/mL with a constant treatment volume of 10 mL/kg bw.
Lithium bis(oxalato)borate (LiBOB) caused 100 % mortality at 2000 mg/kg bw (1/1 animal) and 67 % (2/3 animals) mortality at 550 mg/kg bw. There was no mortality at 175 mg/kg bw. Treatment with lithium bis(oxalato)borate (LiBOB) caused mortality at a dose level of 2000 mg/kg bw, decreased activity (1/3) and mortality (2/3) at 550 mg/kg bw and decreased activity (1/2) at 175 mg/kg bw. The body weight gain of the animals was considered to be normal with no indication of test item related effect. The macroscopic examination revealed some minor alterations including diffuse dark red discoloration of the lungs (1/6) and liver (3/6), dark, punctuate red discoloration of the thymus (bilateral) (1/6), dark, red, discoloration, diffuse, mucosa in ileum (2/6), duodenum, jejunum (1/6). Dilatation, (pelvis, right) and white cloudy fluid was found in one rat’s kidneys.
The study was marked reliable without restrictions and LD50 and LD0 values of 550 and 175 mg/kg bw, respectively, were derived. (LAB, 2010)
supporting study
Acute toxicity of lithium bis(oxalato)borate was investigated by an acute toxic class method in female Wistar rats by oral gavage (dose levels per 3 rats: 50, 50 and 300 mg/kg bw). All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice. Two females, dosed at 300 mg/kg bw, were found dead within 4.5 or 23 hours post-treatment. No further mortality occurred. Clinical signs observed during the study period were as follows: 300 mg/kg: Lethargy, flat and/or hunched posture, uncoordinated movements, laboured respiration, piloerection, ptosis, hypothermia and/or piloerection were noted among the animals between days 1 and 7. 50 mg/kg: Hunched posture was noted on day 1. The body weight gain shown by the surviving animals over the study period was considered to be normal. Dark red discolouration of the gastro-intestinal tract or advanced autolysis was found among the animals that died during the study. Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities. The oral LD50 value of the test substance in Wistar rats was established to be within the range of 50 - 300 mg/kg bodyweight. According to the OECD 423 test guideline the LD50 cut-off value was considered to be 300 mg/kg body weight. (Notox, 2004)
The study from 2004 (OECD 423 - acute classic method) revealed a LD50 value of 300 mg/kg bw whereas only two doses were tested (50 mg/kg and 300 mg/kg). This value (300 mg/kg bw/day) represents the borderline between two categories for the classification of acute oral toxicity (cat. 3 and 4). A LD50 of 550 mg/kg bw was determined in another study in 2010 (OECD 425 - Up and Down Method). Considering both study results, it was concluded that LiBOB needs to be classified as harmful if swallowed (H302), category 4 for acute oral toxicity.
acute dermal toxicity
An acute dermal toxicity study was performed with test item lithium bis(oxalato)borate (LiBOB) in Crl:(WI)BR rats, in compliance with OECD Guideline No.: 402, Directive 92/69 EEC B.3 and OPPTS 870.1200. A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to lithium bis(oxalato)borate (LiBOB) at 2000 mg/kg bw by dermal route. The test item was applied in original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item caused dermal irritation symptoms as slight erythema and other signs (wounds, crusting and desquamation) between Day 1 and Day 10. Slight body weight loss was observed in three females on the first week. It could not be evaluated as a toxic effect of the test item. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. Under the experimental conditions, the acute dermal LD50 value of the test item lithium bis(oxalato)borate (LiBOB) proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. On the other hand, it is to be noted that the test item caused dermal irritation response on the site of administration. (TOXI-COOP, 2011)
supporting study
The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley rat according to OECD guideline 402. A group of ten animals (five males and five females) was given a single, 24-hour, occluded dermal application of the moistened test material to intact skin at a dose level of 2500 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths, no signs of systemic toxicity, but signs of dermal irritation. Further, all animals showed expected gains in bodyweight over the study period. The necropsy did not detect any abnormalities. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley rat was found to be greater than 2500 mg/kg bodyweight. (Zhejiang, 2011)
acute inhalation toxicity
The test substance, LiBOB was evaluated for its acute inhalation toxicity potential when administered to SD rats. The acute inhalation LC50 was estimated to be more than (5220.8 ± 304.6) mg/m³ in both male and female rats. Based on the results, the test substance was classified as “practical non-toxic” by acute inhalation route. The test was performed according to “the Guidelines for the Testing of Chemicals: Test No. 403: Acute Inhalation Toxicity test” (Ministry of Environmental Protection of the People’s Republic of China, 2004)”, the Guidelines for the Hazard Evaluation of New Chemical Substances (Ministry of Environmental Protection of the People’s
Republic of China, 2004) and Technical Rules on Toxicity Testing of Chemicals (Ministry of Health of the People’s Republic of China,2005).
Justification for selection of acute toxicity – oral endpoint
A GLP- and guideline compliant study from 2010 was used for chemical
safety assessment.
Justification for selection of acute toxicity – inhalation endpoint
The study was performed in China under non-GLP conditions. No other
study is available.
Justification for selection of acute toxicity – dermal endpoint
The study from TOXICOOP of 2011 was conducted under GLP conditions.
Justification for classification or non-classification
According to the available study data, lithium bis(oxalato)borate has to be classified and labelled as harmful if swallowed (R22) according to Directive 67/548/EEC (DSD) and as harmful if swallowed (H302), acute toxicity category 4 according to Regulation (EC) No 1272/2008 (CLP).
Based on the available studies on dermal and inhalation toxicity lithium bis(oxalato)borate has not to be classified and labelled according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
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