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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:
1974
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Principles of method if other than guideline:
Acute inhalation toxicity test
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Perhydroazepine
EC Number:
203-875-9
EC Name:
Perhydroazepine
Cas Number:
111-49-9
Molecular formula:
C6H13N
IUPAC Name:
azepane
Details on test material:
- Name of test material (as cited in study report): Hexamethylenimine (HMI)
- Analytical purity: 98 %
- Lot/batch No.: Haskell No. 8588

Test animals

Species:
rat
Strain:
other: ChR-CD
Sex:
male

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
by gas chromatographie
Duration of exposure:
4 h
Concentrations:
0.52, 1.32, 1.95, 2.45, 2.77, 3.12 mg/L air
No. of animals per sex per dose:
6-10 males per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LCLo
Effect level:
2.45 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: 1/6 animals died
Sex:
male
Dose descriptor:
LC50
Effect level:
2.77 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: 3/6 animals died
Mortality:
0.52 mg/L: 0/10 animals died
1.32 mg/L: 0/6 animals died
1.95 mg/L: 0/6 animals died
2.45 mg/L: 1/6 animals died
2.77 mg/L: 3/6 animals died
3.12 mg/L: 6/6 animals died

Any other information on results incl. tables

Laboured breathing was observed in animals starting from 1.32 mg/l air. With increasing doses effects on the lungs, trachea (from laboured breathing to gasping, lung congestion (starting from 1.95 mg/l), nasal discharge) and eyes (corneal opacity) increased. These effects were verified by gross pathology in the ten rats examined.

Gross pathology showing subpleural white plaques, red focal spots, and congestion of the lung following 4-hour exposure to 2.77 mg/L.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the test substance has an LC50 value of 2.77 mg/L air, the LCLo value is 2.45 mg/L air after a 4 h exposure.