Sodium lactate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

The acute oral toxicity of sodium chloride

Author:

Boyd E.M & Shanas M.N.

Year:

1963

Bibliographic source:

Arch. Int. Pharmacodyn. Ther. 144, 86-96

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study conducted before GLP guidelines were published

Test type:

standard acute method

Limit test:

no

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:

NaCl

IUPAC Name:

sodium chloride

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males (202 +/- 42 g), females (167 +/- 27 g)
- Fasting period before study: 16 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

n.a.

Doses:

0, 800, 3000, 3200, 3500, 3800, 4000, 5000, 10000 and 16000 mg/kg bw

No. of animals per sex per dose:

12 to 44 animals

Control animals:

yes

Details on study design:

The rats were observed for toxic signs and mortalities during the acute phase. Food consumption, water intake, bodyweight, urine volume and pH, glucose, protein, and colonic temperature were determined on survivors during the first three days of the test. Fatalities, and survivors after 15 days, were autopsied and examined for gross and microscopic pathologic changes.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 750 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

Convulsions, diarrhea, muscular rigidity and prostration preceded death which was caused by respiratory failure with acute encephalopathy. Major pathologic findings were vascular congestion, particularly in meninges and brain, dehydration, and lysis of columnar epitheli of the gastro-intestinal tract. Survivors suffered a brief anorexia, polyuria, fever and acidosis.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The LD50 for Sodium chloride in rats was found to be 3750 ± 430 mg/kg bw.

Executive summary:

In an acute oral toxicity study, 169 albino Wistar rats (male/female) were exposed once by oral gavage to doses of 0 (controls), 800, 3000, 3200, 3500, 3800, 4000, 5000, 10000 and 16000 mg/kg bw. Animals were observed for 15 days. The rats were observed for toxic signs and mortalities during the acute phase. Food consumption, water intake, bodyweight, urine volume and pH, glucose, protein, and colonic temperature were determined on survivors during the first three days of the test. Fatalities, and survivors after 15 days, were autopsied and examined for gross and microscopic pathologic changes. Based on the results, the LD50 for Sodium chloride in rats was found to be 3750 +/- 430 mg/kg bw (re-calculated to 7190 mg/kg bw Sodium (S)-lactate).