Zirconium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented, scientifically sound study with methods similar to OECD guidline 404 with the following deviations: Not GLP, no information on environmental conditions, and no mention of untreated areas used as controls.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Not GLP, no information on environmental conditions, and no mention of untreated areas used as controls.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium dioxide

EC Number:

215-227-2

EC Name:

Zirconium dioxide

Cas Number:

1314-23-4

IUPAC Name:

1314-23-4

Details on test material:

- Name of test material (as cited in study report): Zirconium oxide
- Molecular formula (if other than submission substance): 97ZrO2 3Y2O3
- Molecular weight (if other than submission substance): 126
- Analytical purity: 99.9 wt% (ZrO2 + Y2O3)
- Physical state: white powder
- Stability under test conditions: nonreactive to water
- Storage condition of test material: cool, dark place (4 +/- 2 degree C); freezing storage (-20 degree C); room temperature (10-30 degree C)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Biotech Co., Ltd
- Age at study initiation: 3 months
- Weight at study initiation: 2.91-3.28 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: no data To: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g; moistened with distilled water for injection
- Concentration (if solution): no data


VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): not applicable
- Purity: not applicable

Duration of treatment / exposure:

4 hours

Observation period:

1, 24 and 48 hours after the lint removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal
- % coverage: no data
- Type of wrap if used: 0.5 g of the test agent was applied to a 2.5 cm square lint (Nankai Sangyou Inc.), and was secured with a piece of White Tape (Nichiban Co., Ltd.). Two application areas were established per each animal. Each area was covered with a piece of oilpaper (Amadin Inc.), and the torso was covered by Silkytex (Alcare Co., Ltd.) to protect and secure the lint.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the area was wiped off with distilled water for injection to remove the test agent
- Time after start of exposure: 4 hours


SCORING SYSTEM: Grades were given based on the Draize scoring method. The skin irritation of the test agent was evaluated according to skin primary irritation evaluation standard of the AFNOR (1982)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24 and 48 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24 and 48 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

other: PCI

Basis:

mean

Time point:

other: 1, 24 and 48 hours

Score:

0

Max. score:

8

Remarks on result:

other: Non-irritant

Irritant / corrosive response data:

No irritation was observed after 48 hours.

Other effects:

There were no abnormalities in the general condition or the weight changes to any of the 3 animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No irritative reaction was acknowledged during the observation period.

Executive summary:

In this GLP study, performed according to the OECD 404 guideline, New Zealand White rabbits were exposed 4 hours to the test susbtance under an occlusive patch. No irritation, nor erythema, nor oedema were observed. The substance was hence determined not to be irritating to New Zealand White rabbit skin after 4 hours of exposure.