Registration Dossier
Registration Dossier
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EC number: 913-635-1 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted prior to GLP and test guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 960
- Report date:
- 1960
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Rats (2 per dose) were exposed (single exposure) to 3980 mg/kg of sodium chloride (administrated as 20% water solution). Mortality and gross pathology were observed.
- GLP compliance:
- no
- Test type:
- other: The test was conducted prior to GLP and test guidelines.
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Details on test material:
- - Name of test material (as cited in study report): Cubidow
Cubidow is almost USP sodium chloride , washed to remove free NaoH and looks like rock salt.
- Physical state: Solid
- Stability under test conditions: Good
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- Rats were fed 20% solution of Cubidow (sodium chloride) in water at the dose of 3.98 g/kg.
- Doses:
- 3.98 g/kg (20% solution in water)
- No. of animals per sex per dose:
- 2
- Control animals:
- not specified
- Details on study design:
- no data
- Statistics:
- no data
Results and discussion
- Preliminary study:
- No data
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 980 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The LD50 value was for 20% solution of cubidow in water
- Mortality:
- No mortality
- Clinical signs:
- other: No data
- Gross pathology:
- Extensive liver and kidney damage were observed at autopsy. No serious untoward reactions were observed.
- Other findings:
- No ne
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Cubidow has low acute oral toxicity. LD50 for 20% solution of cubidow in water is greater than 3980 mg/kgbw.
- Executive summary:
Cubidow has low acute oral toxicity. LD50 for 20% solution of cubidow in water is greater than 3980 mg/kgbw.
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