3-methylbut-3-en-1-ol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968-09-24 (day of exposure)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

BASF Test (internal standard procedure). In principle, the methods described by OECD TG 403 were used.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

other: Inhalation Risk Test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methylbut-3-en-1-ol

EC Number:

212-110-8

EC Name:

3-methylbut-3-en-1-ol

Cas Number:

763-32-6

Molecular formula:

C5H10O

IUPAC Name:

3-methylbut-3-en-1-ol

Details on test material:

- Name of test material (as cited in study report): 3-methyl-3-buten-1-ol
- Analytical purity: 99%
No further data.

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

no further data

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

This test was in principle performed as described in OECD Guideline 403.

- Temperature chosen for vapour generation: 20°C.

GENERAL PROCEDURE
Two groups of 3 rats per sex were exposed sequentially to the vapours by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for different time periods (e.g. 3 min, 10 min, 1 h, 3 h, 7 h or 8 h). The exposure time not causing lethality was usually tested twice.
No analytical determination of the atmosphere concentration was performed. The nominal concentration can be calculated as quotient of the amount of test substance weight loss during the exposure (given in the raw data) and the amount of air used during exposure.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

21.5 mg/l (atmosphere saturated with vapour)

No. of animals per sex per dose:

totally 12 rats (6 males, 6 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Groupwise documentation of clinical signs was performed over the 7-day observation period. Body weight of groups was determined before the start of exposure and at the end of the observation period in surviving animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LCLo

Effect level:

> 21.5 mg/L air (nominal)

Exp. duration:

8 h

Remarks on result:

other: No deaths at saturated vapour concentration.

Mortality:

All animals survived until the end of the 7-day observation period.

Clinical signs:

other: Irritation of the mucosa and dyspnea was observed during exposure. After termination of exposure, imbalance and, for one animal, narcosis was noted. The animals were normal at one day after exposure.

Gross pathology:

Chronic bronchitis was reported for two animals. No pathological findings were observed in the remaining 10 animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

No mortality was observed when 12 rats were exposed for 8 hours to an  atmosphere that had been saturated at 20°C with the volatile parts of the  compound. The concentration of the test substance was 21.5 mg/l (nominal).