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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961

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
Limit test:
no

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
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3 550 mg/kg bw
Based on:
test mat.
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:
Category 5 based on GHS criteria
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 is not classified for oral acute toxicity according to EU GHS criteria (CLP Regulation). According to UN GHS criteria, sodium chloride should be classified Acute. Tox. Cat. 5, H303: May be harmful if swallowed.
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. Based on these results sodium chloride is not classified for oral acute toxicity according to EU GHS (CLP Regulation).