Registration Dossier
Registration Dossier
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EC number: 232-164-6 | CAS number: 7789-41-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Calcium bromide
- EC Number:
- 232-164-6
- EC Name:
- Calcium bromide
- Cas Number:
- 7789-41-5
- Molecular formula:
- CaBr2
- IUPAC Name:
- calcium bromide
- Details on test material:
- White powder, Stored at room temperature over silica gel.
For the purpose of the study the test material was freshly prepared, as required, as a solution at the appropriate concentration in distilled water.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately 2 hours after dosing, free access to mains drinking water and food was allowed throughout the study.
The animal room was maintained at a temperature of 19-22C and relative humidity of 50-55%. The rate of air exchange was approximately 15 changes per hour and the lightning was controlled by a time switch to give 12 hours light and 12 hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- All aniamls were dosed once only by gavage using metal cannula attached to a graduated syringe.
- Doses:
- 2000, 2646 or 3500 mg/kg BW
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- No further details
Results and discussion
- Preliminary study:
- A range finding study was performed to establish a dosing regime, using 5000, 2000, 1000 and 500 mg/kg.
Animals treated with 5000 mg/kg were found dead one day after dosing. Common signs of systemic toxicity were ataxia, hunched posture, lethargy, decreased respiratory rate, and laboured respiration with additional signs of pilo-erection and ptosis. Based on this information, dose levels of 2000, 2646 and 3500 mg/kg bw were selected for the main study.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 210 mg/kg bw
- Based on:
- test mat.
- Remarks:
- CaBr2
- 95% CL:
- > 1 854 - < 2 635
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 573 mg/kg bw
- Based on:
- test mat.
- Remarks:
- CaBr2
- 95% CL:
- > 2 243 - < 2 951
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 512 mg/kg bw
- Based on:
- test mat.
- Remarks:
- CaBr2
- 95% CL:
- > 642 - < 3 561
- Mortality:
- Deaths were noted during the day of dosing and one day after dosing.
- Clinical signs:
- other: Common signs of systemic toxicity noted in all dose groups were ataxia, hunched posture, lethargy, decreased respiratory rate and laboured respiration with additional signs of pilo-erection and ptosis and isolated incidents of red/brown staining around th
- Gross pathology:
- Abnormalities noted at necropsy of animals that died or ere killed in extremis during e study were haemorrhagic lungs, dark liver, dark kidneys, haemorrhage, severe haemorrhage and sloughing of the gastric mucosa, haemorrhage, severe haemorrhage and sloughing of the non-glandular epithelium of the stomach and haemorrhage of the small intestine. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Other findings:
- No further details
Any other information on results incl. tables
No further details
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: other: US EPA
- Conclusions:
- The acute oral median lethal dose (LD50) and 95% confidence limits of the test material, calcium bromide, in the Sprague-Dawley rat were calculated by the method of Thompson W.R to be:
All animals: 2210 (1854-2635) mg/kg bw
Males only: 2573 (2243-2951) mg/kg bw
Females only: 1512 (642-3561) mg/kg bw
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