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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not specified in the report
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The report contains sufficient information to permit a meaningful evaluation of study results
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study methodology followed appeared to be similar to the standard acute method.
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
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): Salt, common salt, halite, table salt, rock salt, sea salt
- Molecular weight: 58.45

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
not specified in the report

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% concentration (water solution)
Doses:
2150, 3160, 4640 and 6810 mg/kg
No. of animals per sex per dose:
5 male rats/dose
Control animals:
not specified
Details on study design:
not specified in the report
Statistics:
not specified in the report

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 550 mg/kg bw
Based on:
test mat.
95% CL:
3 040 - 4 140
Mortality:
Cummulative mortality -
2150 mg/kg - 0/5
3160 mg/kg - 1/5
4640 mg/kg - 5/5
6810 mg/kg - 5/5
Clinical signs:
other: Hypoactivity, muscular weakness, sedation and ruffled fur
Gross pathology:
No significant findings noted in those animals sacrified at termination and inflammation of gastrointestinal tract was noted in those decedents during the course of the study
Other findings:
not specified in the report

Any other information on results incl. tables

not applicable

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of sodium chloride (administered as 25% water solution) was 3550 mg/kg to male rats and based on the results, sodium chloride cannot be classified
Executive summary:

In this study, the acute oral LD50 of sodium chloride was evaluated in male Wistar rats at doses of 2150, 3160, 4640 and 6810 mg/kg, adminsitered as a 25% water solution. 100% mortality was observed at the 4640 and 6810 mg/kg dose groups. The LD50 was 3550 mg/kg with fiducial limits of 3040 -4140 mg/kg.