Barium titanium trioxide

Acute Toxicity: inhalation

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

Justification for type of information:

Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Barium titanium trioxide

EC Number:

234-975-0

EC Name:

Barium titanium trioxide

Cas Number:

12047-27-7

Molecular formula:

Ba.O3Ti

IUPAC Name:

titanium(4+) barium(2+) trioxidandiide

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 or test system 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:

other: 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.