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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
duration of exposure 6 h, purity of the test material not specified, only male animals were used.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Blue Spruce Farms, Inc., Altamont, NY, USA
- Age at study initiation: young adults
- Weight at study initiation: 145 - 195 g
- Housing: individually housed in mesh bottom cages
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 75 L
- Method of particle size determination: every 30 min using a Bausch and Lomb particle counter (model 40-1A)

- Each group of rats was placed in a 75 L chamber equipped with an air supply of 10 L per minute. After the test animals became accustomed to the chamber conditions, the material was sprayed into the air supply at a rate calculated to yield the required concentration of 200 ppm.
- The chamber temperature was recorded every 30 min.
- The control group was exposed only to air for the same length of time.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Particle counts were performed every 30 min using a Bausch and Lomb particle counter (model 40-1A)
Duration of exposure:
6 h
Concentrations:
200 ppm
equal to 2.916 mg/L air (MW = 356.55 g/mol)
No. of animals per sex per dose:
3 (controls), 10 (test substance groups)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: all major tissues and organs were preserved and the lungs and grossly abnormal organs were examined microscopically.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
> 200 ppm
Based on:
test mat.
Exp. duration:
6 h
Sex:
male
Dose descriptor:
LC50
Effect level:
> 2.916 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: based on a molecular weight of 356.55 g/mol
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 7-day observation period.
Gross pathology:
Necropsy examination revealed no substance-related findings.

Any other information on results incl. tables

According to the authors, respirable particles of the test material (≤ 5 µm) were produced.

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
CLP: inconclusive
DSD: inconclusive