Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study. Some details on methods / results not available

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
4 hours exposure to maximum aerosol concentration achievable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas: vapour

Test animals

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

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
VEHICLE
- Composition of vehicle (if applicable): Ethanol
- Concentration of test material in vehicle (if applicable): 80%
- Justification of choice of vehicle: Substance stable in selected vehicle

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 75% of the particles were less than 10 μm indicating a respirable aerosol.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 5.8 μm (GSD = 2.2).
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
1100 mg/m3
No. of animals per sex per dose:
5 male / 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - Daily; Body weights - Days 3, 4, 5, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC0
Effect level:
1 100 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 100 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
None
Clinical signs:
Decreased activity noted during exposure.
Body weight:
Depressed during the first week, followed by recovery during second week.
Gross pathology:
Not remarkable

Applicant's summary and conclusion

Conclusions:
Acute inhalation toxicity following 4 hours exposure to the highest achievable aerosol concentration has been investigated in the rat. The LC50 was in excess of 1100 mg/m³.
Executive summary:

Acute inhalation toxicity following 4 hours exposure to the highest achievable aerosol concentration has been investigated in the rat. The LC50 was in excess of 1100 mg/m³.