Registration Dossier

Administrative data

acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
not reported
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results. Study read across from generator oil.

Data source

Reference Type:

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
Acute inhalation experiments using mice in 2 hour exposures.
GLP compliance:
Limit test:

Test material

Details on test material:
Generator oil.

Test animals

other: white mice
not specified

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
2 h
See Any other information on materials and methods
No. of animals per sex per dose:
110 animals used in the tests
Control animals:
not specified

Results and discussion

Effect levels
Dose descriptor:
Effect level:
19 mg/L air
Based on:
test mat.
Exp. duration:
2 h
Remarks on result:
other: ± 1.4 mg/L

Any other information on results incl. tables

The influence of volatile compounds of generator oil the activity of the movement and irritation of mucosa was observed already at the concentration of 0.18 - 0.25 mg/l. Increasing the concentration of volatile compounds in the chamber up to 5.9 ml/l the mice looked tired (sluggish) during the test and 30 min after the test. In some cases during the second hour of the test dyspnoea was observed. At higher concentrations (10-12 ml/l) in addition to tiredness and dyspnoea, during the second hour of the test the redness of nose, ears and paws was observed.

Increasing the concentration of the volatile compounds up to 29 ml/l and higher during the second hour of the test additionally to lower movement activity, interruptions in movement coordination and dyspnoea in mice ballisms (mostly of the head and paws) were observed; after 10 , 15 and 20 minutes they lost the ability to stand on their feet (took side position). Afterwards the intoxicative appearance and strengthening of spasms was observed. Before death the convulsions gradually stopped. Animals died when breathing progressively weakened. In few cases death came 2-3 days after the test.

In autopsy of white mice, stagnation phenomenon in brain and lungs were observed. Quite often macroscopic signs of degenerative changes in liver were observed.

First signs of intoxication with volatile compounds of generator oil in white mice were observed at concentrations of 0,25 mg/l. The main parameters of toxicity to white mice were as follows: LC0 = 13 mg/l, LC100 = 30 mg/l, LC50 = 19 ± 1.4 mg/l.

As described before we can see that intoxication with volatile compound of generator oil are characterized with the same symptoms as of intoxication with other substances. These kind of symptoms as change in the character of breathing, disorder of movement coordination, cramps, lying on the side etc. are also signs of intoxication with organic solvents; redness of nose, ears and paws are observed in case of intoxication with toluene; head and paw cramps indicate impact of phenols etc.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
The LC50 of generator oil to white mice was 19 ± 1.4 mg/L.
Executive summary:

White mice were exposed to generator oil in an aerosol inhalation experiment for 2 hours.

The LC50 of generator oil to white mice was 19 ± 1.4 mg/L.