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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
(no data on test substance purity, limited documentation)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
(no data on body weight determination during the test; dark / light period 10/14 instead of 12/12)
Principles of method if other than guideline:
Inhalation toxicity was tested according to the method of Sachsse et al. (1973).
K. Sachsse, L. Ullmann, G. Voss and R. Hess: Measurement of inhalation toxicity of aerosols in small laboratory animals. In: Proceedings of the Europ. Soc. for the Study of Drug Toxicity. Vol. XV, pp. 239-251, Zurich, June 1973.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Lot/batch No.: EN 42476.75

Test animals

Species:
rat
Strain:
other: Tif : RAIf (SPF) strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breed
- Weight at study initiation: mean = 190 to 195 g
- Fasting period before study: no data
- Housing: 9 animals to a cage (the males and females were segregated); in Macrolon cages, type 4
- Diet: Rat food - NAFAG, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: for a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

The rats were kept on separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the dust. The exposure was started 15 minutes after onset of the dust production, when the dust had reached an even dispersal throughout the chamber. The dust was generated by injecting the test material with the help of a "Grafix Exaktomat Injector" into an air stream which was discharged into the exposure chamber through a nozzle under a pressure of 2 atm at a rate of 20 L/min.

TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of the dust in the vicinity of the animals was monitored at 1 hour intervals throughout the dust exposure.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- Particle size distribution:
The particle size distribution of the dust in the vicinity of the animals was monitored at 1 hour intervals throughout the dust exposure. The concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell) at an air flow rate of 17.5 L/min. 5% have a particle size < 1 µm and 40% are between 3 - 7 µm, 25 - 30% are between 1 - 3 µm and additionally, 25 - 30% are > 7 µm.

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1692 ± 313 mg/m³ (Average dust concentration, no higher concentrations were possible.)
No. of animals per sex per dose:
9
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.7 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: No mortality and clinical signs observed.
Mortality:
No mortality was observed.
Clinical signs:
During the 4-hour exposure and the subsequent 14-day observation period no toxic symptoms were observed.
Body weight:
No data.
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met