Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent to OECD TG 403 and the report contains sufficient information to permit a meaningful evaluation of study results
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:
1988
Report Date:
1988

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:
not specified
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): UCAR N-pentyl propionate
- Molecular weight: 144.2
- Physical state: clear colourless, low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: BRRC Sample No. 51-19
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 200-300 grams
- Fasting period before study: overnight fasting before dosing
- Housing: group housed
- Diet (e.g. ad libitum): commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
Sprague-Dawley rats were exposed to substantially saturated vapor for 6 hours. The vapor was produced by enclosing approximately 100 grams of the test material in a sealed 100-151 liter animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in distribution of the vapor. Oxygen was added as needed to maintain a chamber oxygen content of approximately 20%.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
6 h
Concentrations:
substantially saturated vapor concentration
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: daily and weights recorded weekly
- Necropsy of survivors performed: yes
Statistics:
LD50 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:
LC0
Effect level:
> 10.07 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: Conversion of a substantially saturated vapor exposure to mg/l
Mortality:
None noted
Clinical signs:
other: None noted
Body weight:
Body weight noted in all the animals of the treated group
Gross pathology:
No gross pathological changes attributable to exposure were noted
Other findings:
not applicable

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, no mortality was noted in Sprague Dawley rats exposed to substantially saturated vapor levels of UCAR n-pentyl propionate (LC0 greater than 10.07 mg/l; converted value) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.
Executive summary:

In this study, groups of 5 male and 5 female Sprague Dawley rats (adults, weighing between 200 -300 grams) were exposed to substantially saturated vapors of UCAR n-pentyl propionate for 6 hours. The vapor was produced by enclosing approximately 100 grams of the test material in a sealed 100-151 liter animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in distribution of the vapor. Oxygen was added as needed to maintain a chamber oxygen content of approximately 20%. There were no mortalities, clinical signs of toxicity and gross pathological signs noted at the end of the study. Body weight gain was noted in all the exposed animals. Under the conditions of the study, no mortality was noted in Sprague Dawley rats exposed to substantially saturated vapor levels of UCAR n-pentyl propionate (LC0 greater than 10.07 mg/l; converted value) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.