Ethyl propionate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1988

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline available

GLP compliance:

not specified

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 200-300g
- Fasting period before study: yes

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

3 to 5 doses , maximum dose not specified, in oil

No. of animals per sex per dose:

5 each sex (female/male)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

male

Dose descriptor:

LD50

Effect level:

> 9.8 mL/kg bw

Based on:

test mat.

Remarks on result:

other: 8.7 g/gk bw /dose were given undiluted

Sex:

female

Dose descriptor:

LD50

Effect level:

10.8 mL/kg bw

Remarks on result:

other: 9.6 g/kg bw

Remarks:

doses were given undiluted

Mortality:

death at 15 min to 1 day

Clinical signs:

other: lethargy and prostragation

Gross pathology:

Necropsy (decents) revealed red lungs, gray stomachs (with clear fluid), white to red intestines (with clear fluid) and grey to red kidneys

lowest lethal dose= 8.0 mL/kg ( 7.1 g/kg bw)

The LD50 values were calculated according to the method of Thompson (1947)

female: LD50=10.8 mL/kg (8.9 to 13.1 mg/L) or 9.6 g/kg bw (7.9 to 11,7 g/kg bw)

male: LD 50 = 9.8 mgL/kg (7.2 -13.6 mL/kg) or 8.7 g/kg bw (6.4 to 12.1 g/kg bw)

 

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of the acute oral toxicity study in Sprague-dawley rats, the test substance has an LD50 value 8.7 to 9.6 g/kg bw.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Animals were exposed to the vapour for defined periods of time or until death occurred, in order to define LT50 values.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl propionate

EC Number:

203-291-4

EC Name:

Ethyl propionate

Cas Number:

105-37-3

Molecular formula:

C5H10O2

IUPAC Name:

ethyl propanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats (200-300 g), using 5 per sex.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: sealed chamber
- Exposure chamber volume: 120 litres
Sample vapour was employed in closed chamber "near saturation". No temperature is given in the report.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

6 h

Remarks on duration:

Exposure lasted for 6 hours or until death occurred.

Concentrations:

Assuming a temperature of 25°C and a saturation of 90%, the vapor pressure of the substance is calculated as 55 hPa *0.9 = 49.5 hPa = 5% (v/v). With 102 g/Mol and 24.4 l/Mol a concentration of 210 mg/l is calculated.

No. of animals per sex per dose:

5 per sex (female/male)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

other: LT50

Effect level:

35 other: minutes

Based on:

test mat.

95% CL:

>= 26 - <= 47

Exp. duration:

6 h

Effect levels 2

Sex:

female

Dose descriptor:

other: LT50

Effect level:

32 other: minutes

Based on:

test mat.

95% CL:

>= 23 - <= 44

Exp. duration:

6 h

Effect levels 3

Sex:

not specified

Dose descriptor:

other: Only lethal exposure

Effect level:

45 other: minutes

Based on:

test mat.

Exp. duration:

6 h

Mortality:

Not specified.

Clinical signs:

other: Laboured breathing, lethargy, ataxia, lacrimation, discharge (nasal, oral) and loss of reflexes.

Gross pathology:

Red lungs, gas-filled stomachs and liquid-filled tracheas.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Based on the results of the acute inhalation toxicity study, LT50s of 35 and 32 minutes were identified in male and female rats, respectively when exposed to near saturated vapor (estimated concentration of 210 mg/l). The available data indicate that a strong irritation of the respiratory tract occurred leading to the lethal effects found in the animals. The test substance will be classified as STOT SE 3 (H335) according to CLP.

Executive summary:

Five male & 5 female Sprague-Dawley rats/dose level were administered the test compound as a near saturated vapour, in a sealed 120 litre chamber containing near saturated vapour for 6 hours or until death occurred. Animals were observed for 14 days. Shorter exposures were also conducted (no additional information provided) in order to calculate the LT50s by using the Thompson method. LT50s of 35 and 32 minutes were identified in male and female rats, respectively. The available data indicate that a strong irritation of the respiratory tract occurred leading to the lethal effects found in the animals. The test substance will be classified as STOT SE 3 (H335) according to CLP.