Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
As described in guideline.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.90 ± 1.82
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
1.60 mg/L air, corresponding to 1600 mg/m3
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.6 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Maximum attainable concentration.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 600 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Maximum attainable concentration.
Mortality:
No deaths occurred.
Clinical signs:
other: Slight nasal discharge and lacrimation during exposure as well as slight, red nasal discharge postexposure.
Body weight:
Slight reduction in the mean body weight gain was noted in females on Day 14 postexposure.
Gross pathology:
The following gross pathology was noted at the terminal sacrifice: one male had dilated, fluid filled left renal pelvis; one male and one female had enlarged mandibular lymph nodes; another female had dilated right renal pelvis containing firm, granular, white material and uterine horns distended with clear fluid; and one female had a dilated right renal pelvis containing white granular fluid. Three of five males and two of five females had no observable abnormal lesions at the terminal sacrifice.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008