Registration Dossier

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:
comparable to guideline study with acceptable restrictions

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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-Geigy, Basel, Switzerland
- Weight at study initiation: 195-200 g
- Housing: The males and females were segregated and kept in Macrolon cages, type 4, (9 animals to a cage).
- Diet: rat food - NAFAG, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: at least 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:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the dust.
- Rate of air: 20 L/min.
- System of generating particulates/aerosols: 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.
- Method of particle size determination: 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.

TEST ATMOSPHERE
- Brief description of analytical method used: The concentration and 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 nm (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.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- Particle size distribution: ca. 42 % particles > 7 µm, ca. 45 % particles of 3-7 µm, ca. 10 % particles of 1-3 µm and ca. 3 % particles of <1 µm
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
9465 ± 632 mg/m3
No. of animals per sex per dose:
9
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
Key result
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
9 465 mg/L air
Based on:
test mat.
95% CL:
> 8 833 - < 10 097
Exp. duration:
4 h
Mortality:
no mortality occured
Clinical signs:
other: no clinical signs were found
Body weight:
no abnormal changes were detected
Gross pathology:
no gross pathology findings were detected

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met