Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
19. Apr 1978 - 05. May 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline studies with acceptable restrictions performed on analogue substance 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Inhalation Hazard Test: The test was performed equivalent or similar to the method described in H.F. Smyth et. al. Am. Ind. Hyg. Ass. 23, 95-107 (1962). Inhalation of an atmosphere enriched at room temperature with the dust of the test material by rats for 7 hours. The documentation of clinical signs was performed over a period of 7 days.
GLP compliance:
no
Test type:
other: Inhalation hazard test.
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Weight at study initiation: male: 185 g (mean), female: 221 g (mean)

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION- pressure in air chamber: 1.013 bar
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 7 h
Concentrations:
7.91 mg/l (nominal)
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days - Frequency of observations: daily- Necropsy of survivors performed: yes- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.61 mg/L air
Based on:
act. ingr.
Exp. duration:
7 h
Mortality:
No mortality was observed.
Clinical signs:
other: 7 h post exposure occured irregular respiration, bloody nose discharge and scrubby fur. 6 days post exposure all animals were considered as normal.
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Analogue substance 1 was tested for inhalation toxicity on rat exposed to dust in a concentration of 5.61 mg/l of active ingredient for 7 hours. The animals of both sex have been observed for 7 days after exposure and the effects reported. No mortality was observed at the concentration of 5.61 mg/l.
Executive summary:

Analogue substance 1 was tested for inhalation toxicity on rat exposed to dust in a concentration of 5.61 mg/l of active ingredient for 7 hours. The animals of both sex have been observed for 7 days after exposure and the effects reported. No mortality was observed at the concentration of 5.61 mg/l.