Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-02-08 to 2000-03-23
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
Chemical structure
Reference substance name:
Yttrium zirconium oxide
EC Number:
264-885-7
EC Name:
Yttrium zirconium oxide
Cas Number:
64417-98-7
Molecular formula:
(ZrO2)x (Y2O3)y 0.59 < x < 1.0 and 0 < y < 0.41
IUPAC Name:
Yttria-Stabilised Zirconia
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): zirconium oxide
- Molecular formula (if other than submission substance): 97ZrO2 3Y2O3 (mole fraction)
- 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: room temperature (10-30 degrees C)
- Further details on test material confidential

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 male animals
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 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:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
not measured/tested
Remarks:
The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
not measured/tested
Remarks:
The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
not measured/tested
Remarks:
The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
not measured/tested
Remarks:
The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
not measured/tested
Remarks:
The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
not measured/tested
Remarks:
The last observation was after 48 h, which is acceptable since no signs of irritation were observed in any of the exposed animals.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24 and 48 hours
Score:
0
Max. score:
8
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
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:
GHS criteria not met
Conclusions:
No irritative reaction was observed during the observation period.