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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute toxicity, oral: Supporting study: Documentation insufficient for assessment. Only few data on test method reported. The oral LD50 in rats is 3500 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment. Only few data on test method are reported.
Principles of method if other than guideline:
An acute oral toxicity test was performed with sodium bromide. Doses between 2000 and 5000 mg/kg bw were administered by stomach tube to albino rats.
GLP compliance:
no
Test type:
other: Only few details on the test method are reported.
Limit test:
no
Species:
rat
Strain:
other: albino rats.
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: from 100 to 200 g.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Sodium bromide was administered by stomach tube to the rats.
Doses:
Between 2000 and 5000 mg/kg bw.
No. of animals per sex per dose:
Groups of 1, 2, 20 and 42 animals.
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 500 mg/kg bw
Based on:
test mat.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 in rats is 3500 mg/kg bw.
Executive summary:

In the present study, male and female albino rats were exposed to concentrations ranging from 2000 to 5000 mg/kg of sodium bromide in order to determine the dose causing death to 50 per cent of the treated animals (LD50). The test substance was administered by stomach tube. The oral LD50 in rats was determined to be 3500 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 500 mg/kg bw
Quality of whole database:
There is only one acute toxicity study available (Klimish score = 3). The documentation insufficient for assessment. Only few data on test method are reported.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Supporting study: Male and female albino rats were exposed to concentrations ranging from 2000 to 5000 mg/kg of sodium bromide, in order to determine the dose causing death to 50 per cent of the treated animals (LD50). The test substance was administered by stomach tube. The oral LD50 in rats was determined to be 3500 mg/kg.


Justification for selection of acute toxicity – oral endpoint
Only one study is available.

Justification for classification or non-classification

Based on available data, sodium bromide is not classified for acute toxicity according to CLP Regulation (EC) no 1272/2008.