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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24 and 48 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24 and 48 hours
Score:
0
Max. score:
4
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.

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