Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Test atmosphere generation not adequately described. Design in principle designed for vapours.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
8h-exposure of rats to a test atmosphere generated by blowing air through a layer of the test substance, 7-day post-treatment observation period
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 172 g (male), 167 g (female)

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h
Analytical verification of test atmosphere concentrations:
no
Remarks:
The nominal concentration could be usuallycalculated as quotient of the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during the exposure.
Duration of exposure:
8 h
Concentrations:
ca. 7.39 mg/l
No. of animals per sex per dose:
12
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: prior to and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
7.39 mg/L air
Exp. duration:
8 h
Remarks on result:
other: dust
Mortality:
no mortalities
Clinical signs:
other: no abnormalities observed
Body weight:
d1: mean 172 g (male), 167 g (female)
d7: mean 198 g (male), 189 g (female)

control animals:
d1: mean 169 g (male), 157 g (female)
d7: mean 197 g (male), 180 g (female)
Gross pathology:
no abnormalities found

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met