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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system, as the inhalation hazard test is insufficient for non-volatile substances.

Data source

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

Materials and methods

Principles of method if other than guideline:
BASF-Test:
This inhalation hazard test demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation. Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of usually 3 rats per sex were sequentially exposed to the vapors, generated by bubbling 200 l/h air through a substance column for different time periods. The exposure time not causing lethality was usually tested twice by conducting 2 independent experiments.
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of the test substance weight loss during exposure. Group-wise documentation of clinical signs was performed over the 14 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals.
However, the inhalation hazard test is insufficient for non-volatile substances.

GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted
Test type:
other: Inhalation hazard test (IHT)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): Heliogenblau MFA
- Analytical purity: ca. 100 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Mean body weight at study initiation:
- Experiment 1: males: 198 g; females: 167 g
- Experiment 2: males: 203 g; females: 170 g

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
- Generation of the vapor atmosphere and exposure of the animals:
A glass flask contained the test material at room temperature. A stream of air (200 l/h) was passed through a 5 cm layer of the test material and streamed into an exposure chamber, where the whole body of the animals was exposed at room temperature for various exposure times.

-The nominal concentration of test substance in the generated exposure atmosphere was calculated as quotient of the amount of (test substance) weight loss during the exposure and the amount of air used during the exposure.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
The authors of the study report calculated the following concentration: average concentration was 1.04 mg/l
No. of animals per sex per dose:
6 animals (3 males and 3 females) per experiment
Control animals:
no
Details on study design:
- 2 groups of 6 young rats (3 males and 3 females) were consecutively exposed to the test substance for 7 hours at room temperature.
- Duration of observation period following administration: 14 days
- The animals were examined for mortality and clinical signs of toxicity
- Frequency of observations: several times at the application day and thereafter once each working day
- Body weights were recorded at the beginning and the end of the study
- Necropsy of survivors and animals which died was performed; the survivors were sacrificed on day 14

Results and discussion

Mortality:
All animals survived, no mortality was observed.
Clinical signs:
other: No clinical signs of toxicity were seen.
Body weight:
The body weights of the individual animals were gathered prior to application of the test material only. No further documentation of body weight data was available.
Gross pathology:
No substance-related findings were seen.

Applicant's summary and conclusion