Reaction Mass of Dialuminium Titanium Pentoxide and Strontium Calcium Aluminosilicate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 5th, 2012 to June 15th, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with GLP and the applicable OECD guideline with no deviations.

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dialuminium titanium pentaoxide

EC Number:

234-456-9

EC Name:

Dialuminium titanium pentaoxide

Cas Number:

12004-39-6

Molecular formula:

Al2O5Ti

IUPAC Name:

Dialuminum titanium pentaoxide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Aluminium titanium oxide.
- Molecular formula (if other than submission substance): Al2TiO5
- Molecular weight (if other than submission substance): 181.83
- Physical state: White powder

Test animals / tissue source

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 16 weeks old.
- Weight at study initiation: 2.82 - 3.01kg
- Housing: Animals were individually housed in aluminium cages (W 360 x D 550 x H 350mm) with wire mesh bottoms.
- Diet (e.g. ad libitum): RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No's 111212 and 120113) ad libitum.
- Water (e.g. ad libitum): Tap Water ad libitum.
- Acclimation period: 21 days acclimation period for the animal in the 1st application and 23 days acclimation for the animals in the 2nd application.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5°C (measured values 20 to 27°C)
- Humidity (%): 55 ± 25% (measured values 36 to 59%)
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12 hors light per day (07:00 - 19:00)

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

For the 1st and 2nd step, a single application of the test material was applied to the conjunctival sac of the left eye.

Observation period (in vivo):

Observations were made at 1, 24, 48 and 72 hours after application.

Number of animals or in vitro replicates:

In the 1st step, one female test animal was used. In the 2nd step, 2 female test animals were used.

Details on study design:

REMOVAL OF TEST SUBSTANCE
Test material was not removed at completion of the exposure period.

SCORING SYSTEM:
The scoring system to assess ocular lesions was Draize Criteria (1959)
Eye irritation effects were evaluated according to the method of Kay and Calandra.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24h

Remarks on result:

other: Grade 1 effects were observed only at the one-hour observation and had resolved in all animals by 24 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No corrosive changes such as necrosis, ulcer or haemorrhage from 1 to 72 hours after application were observed in any animal. Conjunctival redness in animals and discharge in 1 animal were observed at 1 hours application (MTS: 2.7), however, these conjunctival changes had disappeared by 24 hours after application. No irritation reactions were observed in the cornea, iris or conjunctiva of any animal at either 24, 48 or 72 hours after application. In the corneal examination which was performed at 24hours after application, no fluoroscein stainnig marks were observed in any animal.
No abnormalities were observed in the control eye of any test animal.

Other effects:

No abnormal clinical signs were observed in any animal during the 72 hour observation period.
No abnormalities in body weight gain were observed in any animal during the observation period.

Any other information on results incl. tables

Observation 1h 24h 48h 72h Mean (24-72h) Cornea Opacity 0.00 0.00 0.00 0.00 0.00 Iris Lesion 0.00 0.00 0.00 0.00 0.00 Conjunctivae Erythema 1.00 0.00 0.00 0.00 0.00 Oedema 0.00 0.00 0.00 0.00 0.00

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The test material was found to be a minimal eye irritant under the conditions of this study.

Executive summary:

In a study to determine the potential of aluminium titanium oxide to cause irritation or corrosion to the eyes of female Japanese white rabbits. The study was conducted according to GLP and OECD Guideline 405. Conjunctival redness was observed in all animals and discharge in one animal 1 hour after application, however, these conjuctival changes had disappeared 24 hours after application. There were no irritation reactions observed in the cornea, iris or conjunctiva of any animal at either 24, 48 or 72 hours after application. The test material was found to be a minimal eye irritant under the conditions of this study.