Barium titanium trioxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

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

Details on test material:

Test item name : Barium titanate milled ABT-O-21
Other names or
synonyms
: Barium titanate
Lot No. : 33HF-201
Product Code : 1326122
Index No. : 056-002-00-7
CAS No. : 12047-27-7
EINECS No. : 234-975-0
Quantity : 1 kg
Date of manufacture : 2011

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Age / Body weight Young adult / Body weight: 3.4-3.7 kg
Sex: Female
Number: 3
Housing Condition: Conventional rabbit cage system
Temperature: 18 – 22 oC
Humidity: 30 - 70%
Food: Altromin Maintenance Diet #2123 Fortified
Water: Tap water
The test animals were acclimatised for at least 5 days before the test
was conducted

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

0.1 g of test substance was placed in the conjunctival sac of right eye of each animal.
The test substance was removed by rinsing with saline after 1-hour administration.
Dose interval Single dose

Observation period (in vivo):

Observation of both eyes of each animal was conducted at approximately 1hr, 24,
48 and 72 hrs after test substance application

Number of animals or in vitro replicates:

3

Details on study design:

The test substance was removed by rinsing with saline after 1-hour administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hr

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24hr

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

4

Other effects:

No other adverse effect was observed in all the test animals during the observation
period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the above result barium titanate milled ABT-O-21, Lot No: 33HF-201 does not require classification as an eye irritant.

Executive summary:

Both eyes of the animal were examined and scored at 1 hr, 24 hrs, 48 hrs and 72 hrs after administration:

- At any time during the observation period, no severe eye lesions or continuing signs of severe pain or distress was observed in all the three animals;

- Some blood vessels hyperaemic (injected) in conjunctivae (score at 1) was observed in the right (test) eye in 219149115-02-00-1, 219149115-02-00-2 and 219149115-02-00-3 at 1 hour after administration;

- No ocular reaction was observed in both eyes of all the three animals at 24 hr, 48 hr and 72 hr after administration; 9.4 No other adverse effect was observed in all the three animals during the observation period.