Registration Dossier

Administrative data

acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Test guideline
according to
other: Annex V
GLP compliance:
Limit test:

Test material

Details on test material:
Physical form of substance: L
Mass median aerodynamic diameter (for liq.+solid aerosol):

Test animals

other: Rat (Sprague-Dawley)

Administration / exposure

other: None
Details on inhalation exposure:
Nose only
Duration of exposure:
4 h

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5.13 mg/L air
Exp. duration:
4 h
Male: 5.13 mg/L; Number of animals: 5; Number of deaths: 1
Female: 5.13 mg/L; Number of animals: 5; Number of deaths: 1
Clinical signs:
Signs of toxicity related to dose levels:
During exposure, decreased respiratory rate was noted in all
animals and there were occasional instances of laboured
respiration. On removal from the chamber, animals showed
decreased respiratory rate and there were frequent instances
of ataxia. There were occasional occurrences of laboured
respiration, coma and ptosis, isolated instances of lethargy
were also noted. One hour after removal, little or no
change in the condition of the animals was observed. One
male rat died approximately 1 hours after exposure.

One day after exposure, there were frequent instances of
increased respiratory rate and hunched posture. There were
isolated instances of decreased respiratory rate, laboured
respiration, noisy respiration, ataxia, comatose, cyanosis,
lethargy, stained head and red/brown staining around the
snout. The comatose female was humanely killed later in the
day as no improvement was noted and it was considered that
it was unlikely to survive.

By Day 2 surviving animals had shown good signs of recovery,
observations were now limited to increase in respiratory
rate and hunched posture. There were isolated occurrences of
noisy respiration and red/brown staining around the eyes or
snout. A surviving male exhibited sneezing on Day 4 (in
addition to the observations seen on Day 1 post-exposure).
Surviving females appeared normal from Day 5 post-exposure.
One male animal appeared normal on Day 5 but deteriorated
slightly by Day 6 (noisy respiration was now apparent in
this animal as well as in all the remaining surviving
males). These animals recovered slowly to appear normal from
Day 9 post-exposure.
Gross pathology:
Effects on organs:
The lungs of the two animals that died during the study were
found to be filled with fluid and pale or abnormally dark
or with dark patches.

No macroscopic abnormalities were detected in the animals
that survived until the study ended.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU