Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973-02-22
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To evaluate the the acute inhalation toxicity for t-Butylglycidyl ether monomer
- Short description of test conditions: Five female Sprague Dawley albino rats were placed in a 19 liter round glass exposure chamber made from a battery jar. Air was metered through the test material maintained at room temperature or at 140 °C into the chamber at the rate of approximately 1 liter per minute, for seven hours. The nominal concentration was calculated from the ratio of the weight of material vaporized to the total volume of air bubbled through the material during the entire exposure period. The rats were weighed and examined prior to use. During, and for two weeks following exposure, the rats were examined frequently for changes in demeanor and untoward physical effects , including changes in body weight. A gross pathological examination of one of the test animals was performed 24 hours post-exposure. The remaining test animals and untreated controls were sacrificed two weeks post-exposure and subjected to a pathological examination.
- Parameters analysed / observed: Body weight, gross pathology
GLP compliance:
not specified
Test type:
traditional method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature

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: Round glass exposure chamber
- Exposure chamber volume: 19 L
- Method of holding animals in test chamber: Animmals were placed in the jar
- Source and rate of air: Air was metered through the test material at the rate of 1 L/ min
- Temperature: room temperature or 140 °C

TEST ATMOSPHERE
- Brief description of analytical method used: The nominal concentration was calculated from the ratio of the weight of material vaporized to the total volume of air bubbled through the material during the entire exposure period
Duration of exposure:
7 h
Concentrations:
- 17.72 mg/L (3333 ppm), generated at room temperature
- 8 6.02 mg /L (16180 ppm), generated at 140 °C
No. of animals per sex per dose:
5 females
Control animals:
no
Details on study design:
Five female Sprague Dawley albino rats were placed in 19 liter round glass exposure chamber made from a battery jar. Air was metered through the test material maintained at room temperature or at 140 °C into the chamber at the rats of approximately 1 liter per minute, for seven hours. The nominal concentration was calculated from the ratio of the weight of material vaporized to the total volume of air bubbled through the material during he entire exposure period. The rats were weighed and examined prior to use. During and for two weeks following exposure, the rats were examined frequently fro changes in demeanor and untoward physical effects, including changes in body weight. A gross pathological examinantion of one of the test animals was performed 24 hours post exposure. The remaining test animals and untreated controls were sacrificed two weeks post-exposure and subjected to a pathological examination.
Statistics:
Mean body weight and standard deviation

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LC0
Effect level:
17.72 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Key result
Sex:
female
Dose descriptor:
LC50
Effect level:
< 86.02 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Mortality:
No treatment related mortality was observed at a concentration of 17.72 mg/L. At a test concentration of 86.02 mg/L, four out of five rats died after 5.5 to 6.5 hours of exposure.
Clinical signs:
No treatment related signs were observed at concentration of 17.72 mg/L. At a test concentration of 86.02 mg/L, all animals exhibited eye irritation and subsequent corneal opacity as well as gasping and irregular breathing during exposure.
Body weight:
No significant change in body weight was observed.
Gross pathology:
No treatment related signs were observed at concentration of 17.72 mg/L. At a test concentration of 86.02 mg/L, gross pathology of the animals revealed pulmonary edema and effusion.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute inhalation toxicity study, five female Sprague Dawley rats were exposed to 17.72 mg/L and 86.02 mg/L vapour concentrations of the test material for 7 hours. At the test concentration 17.72 mg/L, no treatment related effects were observed. However, at a test concentration of 86.02 mg/L, four out of five rats died. Hence, it can be concluded that the test material was well tolerated up to 17.72 mg/L (LC0) without showing any mortality and classification for acute inhalation toxicity is not warranted.
Executive summary:

In an acute inhalation toxicity study, five female Sprague Dawley rats were exposed whole-body to vapour concentrations of 17.72 mg/L and 86.02 mg/L of t-Butylglycidyl ether monomer for 7 hours. At a test item concentration of 17.72 mg/L, no treatment related effects were observed. However, at a test item concentration of 86.02 mg/L, four out of five rats died. Hence, it can be concluded that the test material was well tolerated up to 17.72 mg/L (LC0) without showing any mortality and classification for acute inhalation toxicity is not warranted.