Sodium propionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 July 1969 - 27 October 1969

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

test item was tested as a 2-30% aqueous solution, observation period was 7 days

Principles of method if other than guideline:

- test item was tested as a 2-30% aqueous solution
- observation period: 7 days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium propionate

EC Number:

205-290-4

EC Name:

Sodium propionate

Cas Number:

137-40-6

Molecular formula:

C3H6O2.Na

IUPAC Name:

sodium propionate

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner/Ottobrunn
- Weight at study initiation: male: approx.165 g, female: approx. 150 g
- Diet: Altromin-"R" (Altromin GmbH, Lage/L.), ad libitum
- Water: ab libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2%, 16% and 30%

MAXIMUM DOSE VOLUME APPLIED: 21.4 mL/kg bw

Doses:

200, 1600, 3200 and 6400 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations daily, weighing at the beginning of the study
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 500 mg/kg bw

Based on:

test mat.

Mortality:

In the highest dose group (6400 mg/kg bw) 3 of 10 female rats died 24 hours after administration of the test item. No further mortality was observed.

Clinical signs:

other: After application of the test item (6400 and 3200 mg/kg bw) prone position, apathy, dyspnoea and shaggy fur were observed. The rats showed no clinical signs after 4 and 7 days, respectively. No clinical signs were observed after application of 1600 and 20

Gross pathology:

no gross pathological findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 for the test substance was determined to be > 6500 mg/kg bw.

Executive summary:

An acute oral toxicity study was performed with Sprague-Dawley rats. The test item was administered as 2-30% aqueous solution via gavage. Administered doses were 200, 1600, 3200 and 6400 mg/kg bw. The oral LD50 for the test substance was determined to be > 6500 mg/kg bw.