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Toxicological information

Acute Toxicity: inhalation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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
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:
study cannot be used for classification
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).