Propyl propionate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to OECD TG 403 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propyl propionate

EC Number:

203-389-7

EC Name:

Propyl propionate

Cas Number:

106-36-5

Molecular formula:

C6H12O2

IUPAC Name:

propyl propanoate

Details on test material:

- Name of test material (as cited in study report): n-propyl propionate
- Physical state: colorless, transparent, low viscosity liquid
- Analytical purity: 100%
- Lot/batch No.: 51-535; 52-19 (15RLRX51)
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 200-300 grams
- Fasting period before study: yes
- Housing: assumed to be group housed
- Diet: ad libitum, appropriate commercial diet, except during the period of fasting
- Water: municipal water, ad libitum

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

The vapor was produced by enclosing approximately 100 g of the test material in a sealed 100 to 152-liter animal chamber for approximately 18 hours (static conditions). A mixing fan periodically agitated the chamber atmosphere to aid in distribution of the vapor. Oxygen was added, as needed, for static exposures to maintain chamber oxygen content of approximately 20%.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

6 h

Concentrations:

Saturated vapor concentration (conversion value of 14031.58 ppm or 66 mg/l, based on vapor pressure of 10.664 mm Hg at 20 °C and molecular weight of 116.16)

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:observed daily and body weights recorded weekly
- Necropsy of survivors performed: yes

Statistics:

LD50's and the estimated LD50 slopes were calculated by the moving average method

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

other: LT50 (lethal time 50)

Effect level:

other: Saturated vapor concentration

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: Saturated vapor concentration (conversion value of 14031.58 ppm or 66 mg/l, based on vapor pressure of 10.664 mm Hg at 20 °C and molecular weight of 116.16)

Mortality:

Exposure to a statically-generated, substantially saturated vapor produced deaths of 2 of 5 female rats within one day, while no mortality was noted in the male rats.

Clinical signs:

other: Hypoactivity, a reduced breathing rate and ataxia were evident during or following exposure.

Body weight:

Body weight gain was noted in all the animals

Gross pathology:

Necropsy revealed dark red lungs in the rats that died, while the survivors had no remarkable gross pathologic findings.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for acute inhalation toxicity.

Executive summary:

In this study, Sprague-Dawley albino rats, weighing between 200 and 300 g, were exposed to substantially saturated vapor for 6 hours. The vapor was produced by enclosing approximately 100 g of the test material in a sealed 100 to 152-liter animal chamber for approximately 18 hours (static conditions). A mixing fan periodically agitated the chamber atmosphere to aid in distribution of the vapor. Oxygen was added, as needed, for static exposures to maintain chamber oxygen content of approximately 20%.

 

Exposure to a statically-generated, substantially saturated vapor (conversion value of 14031.58 ppm or 66 mg/l, based on vapor pressure of 10.664 mm Hg at 20 °C and molecular weight of 116.16) produced deaths of 2 of 5 female rats within one day, while no mortality was noted in the male rats. Hypoactivity, a reduced breathing rate and ataxia were evident during or following exposure. Survivors recovered after one day. Under the conditions of the study and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for acute inhalation toxicity.