Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
no data how the test substance was exposed (as dust, aerosol, ...), only 1 hour exposure
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data provided
Specific details on test material used for the study:
- Name of test material (as cited in study report): Weston MDW-6140-077-01308-M

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: average: 225 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 days

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
The animals were exposed to the test material in a specially constructed, all plexiglas inhalation chamber which has a capacity of 355 cubic liters. Each animal was placed in a separate wire cage during exposure to prevent filtration of inspired air by animal fur. The test material(s) are generated into the test chamber atmosphere by various methods depending upon the nature of the test material. The average nominal sample concentration is calculated by dividing the total amount of test material used by the total volume of the chamber. The chamber is equipped with blowers so that after the test sample was introduced into the chamber's atmosphere the air was continually recirculated during the test period.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
2 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:
All animals survived.
Clinical signs:
other: All animals appeared normal during the 14 day period.
Gross pathology:
Organs of the thorax and abdomen appeared normal.

Applicant's summary and conclusion