Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Method: BASF-Test: Test was performed in principle as described in OECD Guideline 403. The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20°C). 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glassdisc in a glass cylinder for 8h. The documentation of clinical signs was performed over a period of 7 days. In order to verify the results, the test was repeated once.
GLP compliance:
no
Test type:
other: Inhalation-risk test (IRT)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-ethyl-4-methylimidazol
- Physical state: solid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
8 h
Concentrations:
Saturated vapour at 20°C (0.03 mg/L)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7days
- Frequency of observations and weighing: observations: daily; weighing: at the beginning and end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight (group only, no single animal weights)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
0.03 other: Saturated vapour at 20 ºC
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: none of the animals died
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.03 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: theoretical value, calculated based on vapour pressure
Mortality:
No mortality occurred.
Clinical signs:
other: distinct mucous membrane irritation
Body weight:
No data.
Gross pathology:
No treatment related findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met