Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 Jun - 15 Jun 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted 12 May 1981
Qualifier:
equivalent or similar to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Version / remarks:
FIFRA- Guideline §81-3
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Remarks:
SPF Cpb
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 7 - 11 weeks
- Weight at study initiation: 160 - 210g
- Housing: Makrolon-cage Type III; 5 animals per cage
- Diet (e.g. ad libitum): Altromin 1324, ad libitum
- Water (e.g. ad libitum): mains water. ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): ca. 50%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose/head only
Vehicle:
air
Mass median aerodynamic diameter (MMAD):
22.2 µm
Geometric standard deviation (GSD):
1.86
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation chamber
- Exposure chamber volume: ca. 20L
- Method of holding animals in test chamber: fixed in an exposure tube
- Source and rate of air: 60 - 80% of added air is exhausted via an aerosol filter to have continues air flow.
- Method of conditioning air: with two compressors and a downstream compressed air dryer, compressed air is extricated from water dust and oil
- System of generating particulates/aerosols: A glass chamber filled 1/3 with the test substance. With a pressure of max. 100kPa in impulse of 1 second (break between impulses ca. 0.5 second) the substance is swirled up. The airborne, inhalable dust is transferred to the connected inhalation chamber by air blast.
- Method of particle size determination: ANDERSEN - cascades impactor
- Treatment of exhaust air: aerosol filter
- Temperature, humidity, pressure in air chamber: temperature: 22°C, humidity: 5 - 10%

TEST ATMOSPHERE
- Brief description of analytical method used: 10L air with a flow of 4L/min, gravimetric analysis
- Samples taken from breathing zone: yes

TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 22.2µm


Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1933 mg/m³
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: multiple on the day of exposure, observation also on weekend; weighing: before exposure and afterwards weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 933 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no mortality
Clinical signs:
other: no clinical signs
Body weight:
not affected
Gross pathology:
no macroscopic damage
Other findings:
mass amount of inhalable particles (<= 5µm): 1%

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 to male and female rats was determined to be > 1933 mg/m³ air. The substance is not classifiable according to CLP criteria.