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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 70 liters
- Method of holding animals in test chamber: tubes
- Source and rate of air: 20 to 21.9 liters/min
- Temperature, humidity, pressure in air chamber: 20-24 C, humidity 30-70%

TEST ATMOSPHERE
- Brief description of analytical method used: total carbon analyzer
- Samples taken from breathing zone: yes


Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
201600 and 405800 ppm
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight,organ weights,
Statistics:
None - all animals survived the exposures

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 405 000 ppm
Exp. duration:
4 h
Remarks on result:
other: No lethality at highest concentration tested. Exposure equivalent to 1,907,550 mg/m3.
Remarks:
Equivalent to 1907550 mg/m3.
Mortality:
No mortality observed
Clinical signs:
other: Decreased breathing rates reported for 2 males and 2 females at 201600 ppm and in all animals exposed to 405000 ppm.
Body weight:
No effects on body weight observed.
Gross pathology:
Grey discolored lungs were reported for one male and one female of the group exposed to 201600 ppm and in three male and one female exposed to 405000 ppm.

Any other information on results incl. tables

The discoloration of the lungs may have resulted from the exposure, but the absence of histopathological findings in the subsequent 2-week study at 50000 ppm and the absence of other clinical findings in this study suggest that these observations were of minimal toxicological significance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Because mortality did not occur, the 4 hour LC50 value of vapour for the test substance was higher than 405000 ppm (equivalent to 1907550 mg/m3) for both sexes. In addition, immediately after exposure at this high level, signs of narcosis were not seen.