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Toxicological information

Acute Toxicity: inhalation

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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:
other: GLP guidline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: Barium titanate milled ABT-O-21
- Physical state: solid
- Analytical purity: > 99%
- Lot No.: 33 HF-201
- Expiration date of the lot: never

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: National University of Singapore, Centre for Animal Resources (CARE), Singapore
- Age at study initiation: 10 - 12 weeks old
- Weight at study initiation: males: 366 - 386 g; females: 258 - 288 g
- Housing: OptiMICE Caging IVC Systems for Rats
- Diet (e.g. ad libitum): Altromin Maintenance Diet #1324
- Water (e.g. ad libitum): Tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 30 - 70

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The dust cake of the test substance was prepared on the administration day using a hydraulic press at the presssure of 3 tons on 1'/4" DIE.
- Exposure apparatus: TSE Nose (head) only Inhalation Exposure System
- Rate of air: Flow air (L/min) = 15.00; Flow application (L/min) = 15.00; Flow sampling (L/min) = 1.00
- Measurement of actual concentration: Gravimetry method through a filtration unit connected to one of the exposure port.
- Temperature, humidity, in air chamber: A sensor is connected to one of the exposure port.
- Dust generator speed, U/min: 34.008 U/min (maximum)
- Dust generator support / feed, mm/min: 3.418 mm/min (maximum)

TEST ATMOSPHERE
- Particle size distribution: Cascade impactor 0.5 L/min

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: According to OECD 436, the limit dose is 5 mg/L. Based on the technical pre-test of the test item, the maximum attainable dose level was 4.35 mg/L.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Measurement 1: 4.63 mg /L
Measurement 2: 4.75 mg /L
Measurement 3: 5.29 mg /L
Average: 4.89 mg /L
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Adverse effects were observed on each animal twice on the exposure day, and daily up to 14 days. Body weight of each animal was measured on Day 1, 3 and 7.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
4.89 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: maximum attainable concentration
Mortality:
No animal was found dead prior to endpoint day.
Clinical signs:
No adverse effect was observed throughout the observation period.
Body weight:
Body weight changes were in the normal range.
Gross pathology:
No necropsy finding.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the above results, exposing the test item- barium titanate milled ABT-O-21, to rats for 4 hours using TSE Nose (head) only Exposure System, no acute inhalation toxicity was observed on the test system at the maximum attainable concentration of 4.89 mg/L.