Sodium propionate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 November 1981 - 28 Dezember 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

yes

Remarks:

the observation period was 8 days

Principles of method if other than guideline:

observation period: 8 days

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

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:

rabbit

Strain:

Vienna White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: GAUKLER, Offenbach
- Weight at study initiation: average weight: male: 2.97 kg, female: 3.14 kg
- Diet: Ovator-Solikanin 4 mm (Muskator-Werke, Düsseldorf) ad libitum
- Water: ab libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5%

Details on dermal exposure:

TEST SITE
- Area of exposure: average: male: 253 cm², female: 268 cm²
- Type of wrap if used: used but not specified

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water or a water-lutrol-mixture
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: about 5-7 g
- Concentration: 2000 mg/kg (50% aquaeous suspension with 0,5% carboxymethylcellulose)
- Constant concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 8 days (killed on day 8)
- Frequency of observations: daily, on 3 study days
- Necropsy of survivors performed: yes
- Other examinations performed: clinicla signs, local irritation, histopathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: 1 male rabbit showed a minor apathy 50 minutes after substance application.

Gross pathology:

No substance induced findings.

Other findings:

24 hours after application minor skin irritation was observed. 6 days after application scaly skin was observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 for the test substance was determined to be > 2000 mg/kg bw.

Executive summary:

An acute dermal toxicity study was performed with Vienna White rabbits. The test was performed as limit test at 2000 mg/kg bw with 5 male and 5 female animals. The test substance was applied to the shaved skin for 24 hours. The observation period was 8 days. No mortality was observed. The dermal LD50 for the test substance was determined to be > 2000 mg/kg bw.