Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study summary, no guideline and no GLP.
Justification for type of information:
Please see Read Across Justification document in Section 13.2 of IUCLID
Cross-reference
Reason / purpose:
read-across source

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study predates approved guidelines.
Five male and 5 female rats of the Spartan strain was used in this test. The group of 10 rats was placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere containing the dust of 12200 mg/m3 test substance.
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: 09-I2-28
Purity: not specified

Test animals

Species:
rat
Strain:
other: Spartan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: from 226 to 244 grams
- Fasting period before study: not indicated
- Housing: Animals were housed by sex in groups of 5 in metal cages above the dropping.
- Diet (e.g. ad libitum): Purina Laboratory Chow
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): controlled
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Wright Dust Feeder
- Exposure chamber volume: 59.1 liter
- Method of holding animals in test chamber: closed chamber with seperated 4 units of 2 or 3 rats each
- Source and rate of air: Dried and filtered air was passed through the mechanism and directly into the exposure chamber.
- Method of conditioning air: Airflow was regulated by means of a flowmeter.
- System of generating particulates/aerosols: Wright Dust Feeder
- Method of particle size determination: not performed
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
approximately 12200 mg/m3 (The physical properties of the test material preclude the administration of the test compound at higher atmospheric concentrations.)
No. of animals per sex per dose:
5 male and 5 female per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 4 hr, 24 hr and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
none stated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 12 200 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
There were no deaths following a single inhalation dose of the test substance at 12200 mg/m3 air.
Clinical signs:
other: Increased motor activity and slight erythema were observed during the 4 hour exposure period. After 4 hours exposure, 1 rat exhibited salivation. After 24 hours and after 14 days all animals appeared normal.
Body weight:
Normal body weight gain was observed.
Gross pathology:
No information provided.
Other findings:
No information provided.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 was considered to be >12,200 mg/m3 air. The test substance would not be considered a highly toxic material by the inhalation route of administration.
Executive summary:

Five male and 5 female rats of the Spartan strain was used in this test. The group of 10 rats was placed in a sealed 59.1 liter glass chamber and exposed for 4 hours to a dynamic atmosphere containing the dust of 12200 mg/m3 test substance.

The LC50 was considered to be >12,200 mg/m3 air. The test substance would not be considered a highly toxic material by the inhalation route of administration.