Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early sudy, no GLP, outdated methodology, limited report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
only 1 hour exposure
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technically pure

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: MUS-RATTUS AG, Brunnthal, Germany
- Age at study initiation: no data
- Weight at study initiation: male: ca 315 g; female: ca. 217 g
- Fasting period before study: no data

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: ambient air at 1 m³/h
- Method of conditioning air: no data
- System of generating particulates/aerosols: according to B. M. Wright (J.Scient. lnstrum. 27, 12 (1950): "A New Dust Feed Mechanism")
- Method of particle size determination: none
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data

TEST ATMOSPHERE
- Brief description of analytical method used: no data, concentrations were calculated
- Samples taken from breathing zone: no data

VEHICLE
- Composition of vehicle (if applicable): ambient air
- Concentration of test material in vehicle (if applicable): ca 4 mg/L

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 1 h
Concentrations:
calculated as ca. 4 mg/L
No. of animals per sex per dose:
5
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
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 4 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Mortality:
none
Clinical signs:
none
Body weight:
no data
Gross pathology:
no adverse findings
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The minimum lethal concentration after 1 hour of whole body inhalation was above 4 mg/kb bw.
Executive summary:

The inhalation toxicity of the test material was determined in rats. Animals were exposed for 1 hour to a concentration of ca. 4 mg/L (whole body, technical maximum concentration). No adverse effects on general condition nor mortality were observed. At necropsy no effects of the test material were detected.

The mean lethal dose was above 4 mg/L in rats.