Lithium bis(oxalato)borate

Acute Toxicity: inhalation

Administrative data

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Lithium-bis(oxalato)borate

IUPAC Name:

Lithium-bis(oxalato)borate

Constituent 2

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

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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).