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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Reference substance name:
analogue substance 1
IUPAC Name:
analogue substance 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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.