Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting 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:
1953
Report Date:
1953

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Testing saturated vapour concentration
Principles of method if other than guideline:
Inhalation hazard test (rat):
This test (also called inhalation risk test) was performed in principle as described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile com-ponents of a test substance at the temperature chosen for vapor generation (usually 20°C). Young adult laboratory rats were purchased from a breeder. In general, the source and strain of the animals were not documented. 4 rats were exposed sequentially to the vapors, generated by bubbling 100 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 6 - 7 hours.
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during the exposure.
Group-wise documentation of clinical signs was performed over the 7- to 14- day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals.The clinical signs and findings were reported in summarized form. More details can usually be inferred as mentioned for the acute oral studies.
The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with volatile components of the test substance.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
other: saturated vapour concentration
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): N-Vinylimidazol
Specific details on test material used for the study:
PSN I/261

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
> 6 - < 7 h
Remarks on duration:
5x 6-7 hours within 7 days
Concentrations:
- saturated vapour concentration: 0.6 - 2.3 mg/L (about 160 - 600 ppm)
- calculated: 0.0412*MG*VP = 0.0412*94.1 g/mol*0.38 hPa = 1.47 mg/L
No. of animals per sex per dose:
4 rats

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC0
Effect level:
1.47 mg/L air (nominal)
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
no clinical symptoms
Other findings:
no adverse findings in urine and blood parameters

Applicant's summary and conclusion