Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Some information in this page has been claimed confidential.

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
12 May, 1981
GLP compliance:
yes
Test type:
traditional method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Wiga, Sulzfeld, FRG
- Age at study initiation: 7 weeks
- Weight at study initiation: the mean body weights of the male and female rats were 197 g and 168 g
- Fasting period before study:
- Housing: 5 by sex per cage
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5- 25°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
<=
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: modified nose-only inhalation chamber from ADG Developments LTD., Codicote, Hitchin, Herts.SG4 8UB, United Kingdom.
- Exposure chamber volume: ca. 50 L

- airflow: 8.3 m3/h
- System of generating particulates/aerosols: Jetmill
- Temperature, humidity in air chamber: The temperature was 20°C, relative humidity was 18 %.

TEST ATMOSPHERE
- Brief description of analytical method used: Representative samples were obtained by passing 10 1 test atmosphere at ca. 5 l/min through fiber glass filters (Sartorius). Before and after sampling each filter was weighed. The actual concentration was calculated by dividing the weight difference before and after sampling by the amount of air sampled.
- Samples taken from breathing zone: no

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Particle size measurement showed that ca. 83 % of the particles had an aerodynamic diameter equal to or smaller than 4.2 µm.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
The mean actual concentration (and its standard deviation) was 2.95 (0.84) g/m3 Thefluctuations in the concentration were quite large. The nominal concentration was 5.9 g/m3
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were visually inspected just before exposure, for reactions to treatment during the exposure, shortly after exposure, and at least oncedaily during the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.95 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Male: 2.95 mg/L; Number of animals: 5; Number of deaths: 0
Female: 2.95 mg/L; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Shortly after exposure: slight red nasal discharge and soft faeces in all females. Partially closed eyes in 2/5 males and 1/5 females. 7/10 animales had loss of hair in the 2nd week p.a.
Body weight:
No abnormalities in body weight gain were observed, except for a slight weight gain in female no. 7 during the first week of observation.
Gross pathology:
Lung weights were considered to be in a normal range for rats of this strain and age.
Autopsy of the rats revealed no abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a limit study in Wistar rats according to OECD 403 no mortality or relevant clinical effects were observed at reasonably maximal attainable concentration of 2.95 mg/L.