Reaction Mass of Dialuminium Titanium Pentoxide and Strontium Calcium Aluminosilicate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5th March 2012 to 15th June 2012.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other:

Remarks:

Study conducted in accordance with relevnat OECD Guidelines and GLP compliance, with no deviations likely to affect the integrity of the 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Japan Laboratory Animals Inc.
- Age at study initiation: 18 weeks old.
- Weight at study initiation: 3.25 - 3.7kg
- Housing: Housed individually in aluminium cages (W 360 x D 550 x H 350mm) with wire mesh bottoms.
- Diet (e.g. ad libitum): Free access to RC4 pelletd diet (Oriental Yeast Co., Ltd., Lot numbers 111212 and 120113) ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: Animal for the first application was acclimated for 12 days. Animals in the second application were acclimated for 14 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 5°C
- Humidity (%): 55 ± 25%
- Air changes (per hr): 11 to 14 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light (light period from 07:00 to 19:00)

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Amount / concentration applied:

0.5 g of the test material was moistened with 0.5 mL of water for injection.

Duration of treatment / exposure:

In Application 1, the exposure period for step 1 was 3 minutes, for step 2 was 1 hour and for step 3 was 4 hours. In Application 2, the exposure period was for 4 hours.

Observation period:

The test sites for the 1 and 4 hour exposure periods were examined at 1, 24, 48 and 72 hours after removal of the the test material and the skin irritation/corrosion potential of the test material was determined.

In Application 1, the test site of the test animal used in steps 1 to 3 were observed for effects of skin corrosivity immediately after removal of the test test material. For the 3 minute exposure in Application 1, Step 1, the exposure site was observed at 1 and 24 hours after removal of the application.

Clinical observations were conducted immediately after removal of the test material and again after 1 hour for the test animal used in Step 1 to 3 of Application1.

For the two test animals in Application 2, observations for clinincal signs of toxicity were made immedaitely and at 1, 4 and 5 hours after the test material was applied. The day following application and thereafter, each animal was observed once daily up to the day of final observation (day 3 after application).

All test animals were weighed on the day of application and on the final day of observation.

Number of animals:

First application: 1 animal
Second application: 2 animals.

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the animal, approximately 2.5 cm x 2.5 cm.
- Type of wrap if used: The test material was applied to a lint patch lined with oil paper. The patch was applied to the application site and covered with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The areas of exposure were wiped with absorbent cotton soaked with water.
- Time after start of exposure: In the first application, for step 1, the test material was removed after 3 minutes exposure, in step 2, the material was removed after 1 hour exposure and in step 3, the material was removed after 4 hours exposure.

In the second application, the treated areas were wiped after 4 hours exposure to the test material.

SCORING SYSTEM: Scored according to Draize Criteria (1959).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

other: No effects were observed at any time point, in any animal

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed

Remarks on result:

other: No effects were observed at any time point, in any animal

Irritant / corrosive response data:

In Application 1, step 1, after 3 minutes exposure, no corrosive change was observed immediately after removal of the test application. No skin reactions including erythema or oedema were observed at 1 or 24 hours after removal of the test material.

In Application 1, step 2, after 1 hour exposure, no corrosive change was observed immedaitely after removal of the test application. No skin reactions including erythema or oedema were observed at 1, 24. 48 or 72 hours after removal of the test material.

In Application 1, step 3, after 4 hours exposure, no corrosive change was observed immedaitely after removal of the test application. No skin reactions including erythema or oedema were observed at 1, 24. 48 or 72 hours after removal of the test material. Individual mean values at 24, 48 and 72 hours after removal of the application was 0.

In Applicaiton 2, step 4, after 4 hours exposure, no corrosive change was observed immedaitely after removal of the test application. No skin reactions including erythema or oedema were observed at 1, 24. 48 or 72 hours after removal of the test material. Individual mean values at 24, 48 and 72 hours after removal of the application was 0 for each animal.

Other effects:

No abnormal clinical signs were observed in any test animal during the observation period.

No abnormalities in body weight gain were observed in any animal during the observation period.

Any other information on results incl. tables

No additional information.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

Under the conditions of this study, the test material, Aluminium titanium oxide was not considered to be irritating or corrosive.

Executive summary:

In a study conducted to determine the potential of aluminium titanium oxide to cause skin irritation or corrosion, a study was conducted in Japanese White rabbits in accordance with OECD Guideline 404 and GLP. There were no signs of irritation or corrosion observed at any of the time-points investigated.