Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature (handbook)

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., 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:
Method: other: Repeated inhalation toxicity
GLP compliance:
not specified
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

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
7 days
Frequency of treatment:
6 hour/day
Doses / concentrations
Remarks:
Doses / Concentrations:
150, 500 or 1500 ppm (0.54; 1.8; 5.4 mg/L)
Basis:
no data
No. of animals per sex per dose:
8 animals/dose and control.
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes



Sacrifice and pathology:
GROSS PATHOLOGY: Yes
Other examinations:
Organ weights: Yes

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
effects observed, treatment-related
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Animals exposed to the highest concentration exhibited motor incoordination after the first two exposures but not after seven exposures, suggesting that some tolerance may have occurred. They appeared lethargic for 3 to 4 hours after exposure. There was an increase in both absolute and relative liver and kidney weights and a decrease in blood glucose level; gross pathologic examination did not reveal any consistent changes attributable to exposure

Applicant's summary and conclusion

Conclusions:
The repeated dose toxicity (inhalation) of the test item on rats was examined. Minor effects were observed. Animals exposed to the highest concentration exhibited for example motor incoordination after the first two exposures but not after seven exposures, suggesting that some tolerance may have occurred. No NOAEC was determined.
Executive summary:

The repeated dose toxicity (inhalation) of the test item was examined. Rats were exposed to the test item over a period of 7 days with a frequency of 6 hours per day. 8 animals per dose and control were used. The animals were exposed to doses of 150, 500 and 1500 ppm equivalent to doses of 0.54, 1.8 and 5.4 mg/L. Control animals were not treated. As a result animals exposed to the highest concentration exhibited motor incoordination after the first two exposures but not after seven exposures, suggesting that some tolerance may have occurred. They appeared lethargic for 3 to 4 hours after exposure. There was an increase in both absolute and relative liver and kidney weights and a decrease in blood glucose level; gross pathologic examination did not reveal any consistent changes attributable to exposure. No further information are available.