2-methylbutan-2-ol

Repeated dose toxicity: inhalation

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

Test material information

Constituent 1

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.