Sodium chloride

Acute Toxicity: oral

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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

Test material information

Constituent 1

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.