Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature

Data source

Reference
Reference Type:
review article or handbook
Title:
Patty's Industrial Hygiene and Toxicology
Author:
Rowe and McCollister
Year:
1982
Bibliographic source:
Clayton and Clayton (eds.), Vol.2C, 3rd ed. (1982), John Wiley & Sons, New York, 4604 - 4605, 4608, 4701

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute inhalation toxicity, no further details
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-2-ol
EC Number:
200-908-9
EC Name:
2-methylbutan-2-ol
Cas Number:
75-85-4
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-2-ol

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of inhalation exposure:
not specified
Vehicle:
not specified
Duration of exposure:
6 h
Concentrations:
Nominal concentrations: 15800; 5700; 3000 and 1100 ppm (57; 20.6; 10.8; 4 mg/L)
No. of animals per sex per dose:
4
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC100
Effect level:
5 700 ppm
Exp. duration:
6 h
Remarks on result:
other: 20.6 mg/L
Sex:
not specified
Dose descriptor:
LC50
Effect level:
>= 3 000 - <= 5 700 ppm
Exp. duration:
6 h
Remarks on result:
other: between 20.6 and 10.8 mg/L
Mortality:
At top level all animals dead.
5700 ppm: All were dead within 24 hours
Clinical signs:
other: Motor incoordination
Body weight:
Loss of body weight
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

15800 ppm (57 mg/L) : At the top level, all animals exhibited motor incoordination within 90 min. and all were dead within 3 hours. 5700 ppm (20.6 mg/L): Those exposed to 5700 ppm were unconscious at the end of exposure and died within 24 hours. Deaths were believed to be due to respiratory failure. 3000 ppm (10.8 mg/L): The rats exposed to 3000 ppm were als unconscious at the end of the exposure, lost weight for a few days and then recovered and survived. 1100 ppm (4 mg/L): Those exposed to 1100 ppm exhibited slight motor inccordination at the end of the exposure, appeared normal 24 hours later, experienced no weight loss and survived.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute inhalation toxicity of the test item was determined. The LD50 was determined to be between 3000 and 5700 ppm (equivalent to 10990.556 and 20882.057 mg/m^3)
Executive summary:

The acute inhalation toxicity of the test item was determined. The standard acute method was conducted with 4 rats. Nominal concentration of 15800, 5700, 3000 and 1100 ppm (57, 20.6, 10.8 and 4 mg/L) were used. The rats were exposed to the test item over a period of 6 h. As a result the LC100 was determined to be 5700 ppm and the LC50 was determined to be between 3000 and 5700 ppm (equivalent to 10990.556 and 20882.057 mg/m^3). Furthermore at the top level, all animals exhibited motor incoordination within 90 min. and all were dead within 3 hours. 5700 ppm (20.6 mg/L): Those exposed to 5700 ppm were unconscious at the end of exposure and died within 24 hours. Deaths were believed to be due to respiratory failure. 3000 ppm (10.8 mg/L): The rats exposed to 3000 ppm were als unconscious at the end of the exposure, lost weight for a few days and then recovered and survived. 1100 ppm (4 mg/L): Those exposed to 1100 ppm exhibited slight motor inccordination at the end of the exposure, appeared normal 24 hours later, experienced no weight loss and survived.