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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
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.