Lithium bromide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-02-02 to 1988-02-16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study equivalent to guideline with minor insufficiencies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Please refer to section "Principles of method if other than guideline"

Principles of method if other than guideline:

Only three rodents per sex and dose were used. The limit test was conducted with a lower dose (500 mg/kg instead of at least 2000 mg/kg).

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium bromide

EC Number:

231-439-8

EC Name:

Lithium bromide

Cas Number:

7550-35-8

Molecular formula:

BrLi

IUPAC Name:

lithium bromide

Test material form:

other: solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, New York, US
- Age at study initiation: young adults
- Weight at study initiation: 209-263 g
- Fasting period before study: fasted overnight prior to dosing
- Housing: individually housed in stainless steel suspended rat cages
- Diet (e.g. ad libitum): Purina Laboratory Rodent Chow 5001, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-71
- Humidity (%): 27-59
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10 % (w/v) solution
- Amount of vehicle (if gavage): 1.0-1.3 mL


MAXIMUM DOSE VOLUME APPLIED: 1.3 mL

Doses:

500 mg/kg bw

No. of animals per sex per dose:

3 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 3 hours after administration on the day of dosing and daily thereafter for fourteen days. Body weights were taken on the day of dosing and again on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

The only clinical signs noted were chromorhinorrhea, diarrhea and abdominogenital staining during the first 24-hours post-dosing.

Body weight:

All rats gained weight by day 14 of the study.

Gross pathology:

There were no gross internal lesions observed in any animal at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the study conditions a LD50 > 500 mg/kg bw was determined for lithium bromide.

Executive summary:

An acute oral toxicity study according to the non-definitive protocol of FMC was performed with lithium bromide. Sprague-Dawley rats (3 males and 3 females) were orally dosed with lithium bromide anhydrous as a 10.0 % (weight/volume) solution in tap water at a dosage level of 500 mg/kg bw. Observations for toxicity were conducted at approximately 3 hours after dosing and daily thereafter for fourteen days. Body weights were recorded on days 0, 7 and 14 of the study. A gross necropsy was performed on all animals. There were no deaths. The only clinical signs noted were chromorhinorrhea, diarrhea and abdominogenital staining during the first 24-hours post-dosing. All rats gained weight during the study. At necropsy, no gross internal lesions were observed. A LD50 of greater than 500 mg/kg bw could be derived. (FMC, 1988)