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EC number: 251-347-1 | CAS number: 33021-02-2
Toxicological information
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1-(1,1-dimethylethoxy)-2-methylpropane
- EC Number:
- 251-347-1
- EC Name:
- 1-(1,1-dimethylethoxy)-2-methylpropane
- Cas Number:
- 33021-02-2
- Molecular formula:
- C8H18O
- IUPAC Name:
- 1-(tert-butoxy)-2-methylpropane
- Details on test material:
- - Name of test material (as cited in study report): iso-butyl-t-butylether.
- Physical state: clear, colourless liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Labaz, Brussels, Belgium
- Weight at study initiation: mean ca. 200 g (males and females)
- Housing: 5/cage in stainless steel cages
- Diet (e.g. ad libitum): Institute's stock diet for rats; ad libitum
- Water (e.g. ad libitum): bottled unfluoridated water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 50 - 60
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass cylinders (0.90 x 0.15 m) with sampling ports at both ends, and a stainless steel interior
- Source and rate of air: filtered, compressor generated main airflow, 6 l/min
- System of generating particulates/aerosols: by passing a filtered compressor generated airflow through a glass evaporator containing the test substance
- Temperature, humidity: 23 - 27 °C, 65 -80%
TEST ATMOSPHERE
- Brief description of analytical method used: by gaschromatography
- Samples taken from breathing zone: no - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Samples of the test atmospheres were taken from the sampling ports at both sides 2 to 4 times/hour and were analyzed by gas chromatography, using an "Intersmat" gaschromatograph with a FID (flame ionisation detector) and a stainless steel column.
- Duration of exposure:
- 4 h
- Concentrations:
- 8029, 10754, 13679 ppm (ca. 42.9, 57.7, 73.2 mg/l)
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: regulary
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 73 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: vapor
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- > 73 mg/L air
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- ca. 58.8 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- - 73.2 mg/l air: 2/10 males died within 3 h; 6/10 males and 2/10 females died within 4 h; 8/10 males and 2/10 females died within 14 days
- 57.5 mg/l air: 4/10 males died within 4 h
- 42.9 mg/l air: no mortality - Clinical signs:
- other: During the first 30 minutes of the exposure period the animals were very restless, kept their eyes half-closed and showed nasal discharge and salivation, especially the rats of the mid and high dose groups. In the mid-dose group the animals showed tremors
- Body weight:
- The mean body weights was only slightly retarded in females of the mid-dose group.
- Gross pathology:
- Macroscopic examination at autopsy revealed overfilled urinary bladders and red (congested) lungs in all animals of the high dose group that died during the exposure period. No abnormalities were observed in animals of the intermediate dose group that died during the exposure period.
In animals autopsied after the observation period slight lesions were observed in the high dose group only. They consisted of red spots in the lungs
of one male and petechia in the lungs of two females.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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