Registration Dossier

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
only male animals tested; lack of details on test substance
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gravimetric analyses were performed to determine the respirable test substance concentration.
Duration of exposure:
6 h
Concentrations:
28.1 µL/L air (calculated concentration)
measured respirable test substance concentration: 1.97 µL/ L air (< 5 and < 10 µm diameter particle size)
No. of animals per sex per dose:
10
Control animals:
other: yes, sham-exposed

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
> 1.97 other: µL/L air (analytical)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: max. attainable concentration
Sex:
male
Dose descriptor:
LC50
Effect level:
> 1.86 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: converted from µL/L by using a mean specific gravity value of 0.947
Mortality:
No mortality occured during the study period.
Clinical signs:
other: No clinical signs toxicity were observed in any of the animals during the 14-day observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
No abnormal findings.

Applicant's summary and conclusion

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