Registration Dossier

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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.