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Acute Toxicity: inhalation

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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 or similar to OECD TG 403 and the report contains sufficient information to permit a meaningful evaluation of study results
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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
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

Constituent 1
Chemical structure
Reference substance name:
Butyl propionate
EC Number:
209-669-5
EC Name:
Butyl propionate
Cas Number:
590-01-2
Molecular formula:
C7H14O2
IUPAC Name:
butyl propanoate
Details on test material:
- Name of test material (as cited in study report): UCAR n-butyl propionate
- Physical state: clear clolourless low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: 51-18
- Stability under test conditions: yes
- Storage condition of test material: at 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
- Diet (e.g. ad libitum): ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
not specified
Details on inhalation exposure:
Vapors of UCAR n-butyl propionate were produced by enclosing approximately 100 grams in a sealed 100-151 liters animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in the distribution of vapor. Oxygen was added, as and when 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 vapors
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: clinical signs were recorded daily and body weights recorded on a weekly basis
- Necropsy of survivors performed: yes
Statistics:
Descriptive statistical methods were used.

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 23.78 mg/L air
Based on:
other: conversion of saturated vapor concentration (4473.68 ppm, based on saturated vapor concentration of 3.4 mm Hg at 20 °C)
Exp. duration:
6 h
Mortality:
No mortalities were noted
Clinical signs:
other: No clinical signs of toxicity were noted
Body weight:
Normal body weight gain was noted in all the animals
Gross pathology:
No gross pathological changes were noted
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 as no mortality was observed in rats exposed to substantially saturated vapors (equivalent to 23.78 mg/l air) of UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for acute inhalation toxicity.
Executive summary:

In this study, groups of male and female Sprague Dawley rats were exposed (whole body) to substantially saturated vapor levels of UCAR n-butyl propionate for 6 hours. Vapors of UCAR n-butyl propionate were produced by enclosing approximately 100 grams in a sealed 100-151 liters animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in the distribution of vapor. Oxygen was added, as and when needed to maintain a chamber oxygen content of approximately 20%. Clinical signs were recorded daily and body weights recorded on a weekly basis until day 14. During the study, no mortalities and clinical signs of toxicity were noted. Normal body weight gain was noted in all the animals and no gross pathological changes were noted at termination on day 14.

Under the conditions of the study as no mortality was observed in rats exposed to substantially saturated vapors (equivalent to LC50 > 23.78 mg/l air) of UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for acute inhalation toxicity.