Registration Dossier

Diss Factsheets

Administrative data

Description of key information

1. Information on zirconium dioxide (CAS# 1314-23-4)
Skin irritation / corrosion:
Based on the test results (in vivo study performed according to OECD guideline 404), zirconium dioxide was determined not to be irritating to the skin of New Zealand White rabbit.
Eye irritation:
Based on the test results obtained with New Zealand White rabbit (in vivo study cfr. OECD guideline 405), zirconium dioxide (a form stabilised with yttrium oxide, which is a similar non-hazardous metal oxide) should not be classified for eye irritation according to the CLP rules.
2. Information on erbium oxide (CAS# 12061-16-4)
Skin irritation/corrosion:
Erbium oxide was determined to be not irritating to the skin of New Zealand White rabbits in an in vivo study.
Eye irritation:
Based on the results obtained with New Zealand White rabbit (in vivo study), erbium oxide should not be classified for eye irritation according to the CLP rules.
3. Conclusion on erbium zirconium oxide
Based on the data on the individual components in the 'solid solution', it can be concluded that erbium zirconium oxide is not irritating to skin or eyes and does not need to be classified for these endpoints.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Read across based on the study from BIBRA (1986) with zirconium dioxide and a study from Shapiro (1990) with erbium oxide. The read across justification document is attached in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
other: read across conclusion
Remarks on result:
other: Erbium zirconium oxide was concluded not to be irritant to skin, in vivo, based on the read across study from BIBRA (1986) performed with zirconium dioxide, and the read across study of Shapiro (1990) performed with dierbium trioxide.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1986-03-04 to 1986-07-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test substance was tested simultaneously on the same animals.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Substances were tested simultaneously on the same animals
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Regal Rabbits, Great Bookham, Surrey
- Housing: individually in metal grid-floored cages
- Diet: ad libitum, Grain Harvester's special rabbit diet 679
- Water: ad libitum tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 43-74
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): spread on a patch previously moistened with 0.5 mL of water to ensure good contact with the skin
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
4 male animals
Details on study design:
TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: 2.5 cm square patches were applied to the skin on 6 cm square patches of polythene held in place by adhesive tape and elastic net bandages.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize (1959), Indices of irritation were calculated for each animal by totalling the scores for oedema and erythema for each animal and dividing by two.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No reaction to the test substances was reported in any of the test animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was determined to be not irritating to the skin of rabbits.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
5 November 1990 - 8 November 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
equivalent or similar to guideline
Guideline:
other: FHSA 16 CFR 1500.41
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Acclimation period: 12 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 °C

IN-LIFE DATES: From: 5 November 1990 To: 8 November 1990
Type of coverage:
occlusive
Preparation of test site:
other: abraded and shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of the test material was placed on each of the test sites (i.e. abraded and intact skin).
Duration of treatment / exposure:
24 hours
Observation period:
72 hours. Evaluation occurred 24 and 72 hours after exposure.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² (two per rabbit, one intact and one abraded).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently wiped clean of any residual test material.
- Time after start of exposure: after 24 hours of exposure.

SCORING SYSTEM:

Erythema and eschar formation:
0: No erythema:
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading

Oedema formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (edges raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean at 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean of 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Abraded skin
Irritant / corrosive response data:
All sites were clear of irritation during the test period.
Other effects:
All animals appeared active and healthy.

Table 1 Primary Dermal Irritation (PDI) Scores - Individual Results

Rabbit

24 hours

72 hours

Abraded

Intact

Abraded

Intact

7740

7741

7742

7743

7744

7745

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

0/0

Total

0/0

0/0

0/0

0/0

Mean

0/0

0/0

0/0

0/0

Key: erythema and eschar / oedema

Interpretation of results:
other: Not classified according to EU criteria.
Conclusions:
Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.
Executive summary:

The primary skin irritation potential of the test material was investigated in a study which was broadly conducted in accordance with the FHSA guideline 16 CFR 1500.41.

During the study 0.5 g of the test material was applied to both an intact and abraded site on each of six New Zealand White rabbits. The sites were occluded for 24 hours. The patches were then removed and the test sites wiped to prevent further exposure. Evaluation occurred 24 and 72 hours after exposure.

All sites were clear of irritation during the test period and the Primary Dermal Irritation Index was 0.0.

Under the conditions of this study, the test material is not irritating to skin and requires no classification in accordance with the EU criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
13 November 1990 - 16 November 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Qualifier:
equivalent or similar to guideline
Guideline:
other: FHSA 16 CFR 1500.42
Deviations:
no
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C

IN-LIFE DATES: From: To: 25 October 1990 - 16 November 1990
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
undiluted
Amount applied: 0.1 g
Duration of treatment / exposure:
Three of the treated eyes were rinsed 30 seconds post-installation.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6; 3 male, 3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): three of the treated eyes were rinsed with 30 cc of saline solution.
- Time after start of exposure: 30 seconds post-exposure.

- Scoring system: according to the method of Draize. Ocular lesions were evaluated at 24, 48 and 72 hours post installation. Fluorescein was used at the 24 hour evaluation.

Draize Scale for Scoring Ocular Irritation

1. CONJUNCTIVAE

(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal............................................................................................................................................0
Vessels definitely injected above normal................................................................................................1
More diffuse, deeper crimson red, individual vessels not easily discernible....................................2
Diffuse beefy red.........................................................................................................................................3

(B) Chemosis
No swelling..................................................................................................................................................0
Any swelling above normal (includes nictitating membrane).............................................................1
Obvious swelling with partial eversion of lids.......................................................................................2
Swelling with lids about half closed.........................................................................................................3
Swelling with lids half closed to completely closed...............................................................................4

(C) Discharge
No discharge...............................................................................................................................................0
Any amount different from normal (does not include small amounts observed in inner
canthus of normal animals)......................................................................................................................1
Discharge with moistening of the lids and hairs just adjacent to lids...............................................2
Discharge with moistening of the lids and hairs a considerable area around the eye...................3

THE TOTAL SCORE = (A + B + C) x 2 MAXIMUM TOTAL = 20

2. IRIS

(D) Values
Normal.........................................................................................................................................................0
Folds above normal, congestion, swelling, circumcorneal injection (any or all
of these or combination of any thereof) iris still reacting to light
(sluggish reaction is positive).................................................................................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these)....................................2

THE TOTAL SCORE = D x 5 MAXIMUM TOTAL = 10

3. CORNEA

(E) Degree of Opacity (most dense area used)
No opacity...................................................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible......................................................................1
Easily discernible translucent areas, details of iris slightly obscured..............................................2
Opalescent areas, no details of iris visible, size of pupil barely discernible....................................3
Opaque, iris not discernible through the opacity................................................................................4

(F) Area of Cornea Involved
One quarter (or less) but not zero..........................................................................................................1
Greater than one quarter but less than half...........................................................................................2
Greater than half but less than three quarters......................................................................................3
Greater than three quarters, up to whole area.......................................................................................4

THE TOTAL SCORE = (E x F) x 5 MAXIMUM TOTAL = 80

MAXIMUM TOTAL SCORE POSSIBLE = 110
Irritation parameter:
cornea opacity score
Basis:
animal: 7806
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
cornea opacity score
Basis:
animal: 7807
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
cornea opacity score
Basis:
animal: 7808
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
cornea opacity score
Basis:
animal: 7809
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
cornea opacity score
Basis:
animal: 7810
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
cornea opacity score
Basis:
animal: 7811
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
iris score
Basis:
animal: 7806
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal: 7807
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
iris score
Basis:
animal: 7808
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal: 7809
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
iris score
Basis:
animal: 7810
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
iris score
Basis:
animal: 7811
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: n/a
Irritation parameter:
conjunctivae score
Basis:
animal: 7806
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: 7807
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: 7808
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: 7809
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: 7810
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: 7811
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 7806
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 7807
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 7808
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: 7809
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 7810
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: 7811
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Irritant / corrosive response data:
-No corneal opacity was noted in any of the treated eyes.
-Iritis was observed in two unwashed eyes 24 hours post installation and in one eye at 48 hours. By 72 hours all eyes were free of iritis. Iritis was not observed in any of the washed eyes.
-Conjunctival irritation was noted in all eyes 24 and 48 hours after administration. This remained in one unwashed and two washed eyes after 72 hours.
Other effects:
All animals appeared active and healthy. No signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour were observed.

Table 1 Individual Results

Time Point (hours)

Rabbit Number

Cornea

Iris

Conjunctivae

Chemosis

Discharge

 

 

24

7806

7807

7808

7809

7810

7811

0

0

0

0

0

0

1

0

1

0

0

0

2

2

2

2

1

1

2

1

1

1

1

1

3

2

2

1

2

1

 

 

48

7806

7807

7808

7809

7810

7811

0

0

0

0

0

0

0

0

1

0

0

0

1

2

1

1

1

2

1

1

0

1

1

1

1

0

0

0

0

0

 

 

72

7806

7807

7808

7809

7810

7811

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

1

0

1

0

0

1

1

0

0

0

0

0

0

Rabbits 7809, 7810 and 7811 had the treated eye rinsed with 30 cc of saline solution 30 seconds post-installation

Interpretation of results:
other: Not classified according to EU criteria.
Conclusions:
Under the conditions of the study the test material produced minimal irritation to both the unwashed and washed eyes.
Executive summary:

The eye irritation potential of the test material was investigated in a study which was broadly conducted in accordance with FHSA guideline16 CFR 1500.42. During the study 0.1 g of the test material was instilled into the left eye of six New Zealand white rabbits, with three of the treated eyes being rinsed after 30 seconds with saline. The animals were observed for three days and the eyes examined at 24, 48 and 72 hours. Irritation was scored according to the method of Draize.

 

Under the conditions of the study the test material produced minimal irritation to both the unwashed and washed eyes. No classification is required in accordance with EU criteria. 

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2000-02-08 to 2000-03-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well documented, scientifically sound study according to a method similar to OECD guideline 405 with a few deviations. However, not GLP, no information on environmental conditions, individual eye endpoints (cornea, iris, conjunctiva) not reported in the results.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
not GLP, no information on environmental conditions, individual eye endpoints (cornea, iris, conjunctiva) were not reported in the results
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Biotech Co., Ltd
- Age at study initiation: 4 months old
- Weight at study initiation: 3.22-3.59 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
Vehicle:
unchanged (no vehicle)
Controls:
other: right eyes were kept as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3 animals (administered to the left eye of each animal)
Details on study design:
SCORING SYSTEM: According to Draize's standard (1959). Cornea, iris and conjunctiva were observed, and acknowledged damages were recorded. After calculating the total scores of each observation of each animal (Individual ocular irritation index, IOI) and the average score of each observation of each group (Mean ocular irritation index, MOI), the evaluation was made according to the AFNOR (1982) evaluation criteria. The acute ocular irritation index (AOI) was defined as the maximum of the MOI.

Accident Value Test of Corneal Epithelium: After the accident value test of anterior ocular segment done 24 hours after the application, corneal epithelium were dyed with fluorescein, and the stainability was evaluated.

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 hour
Score:
4.7
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
24 h
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
48 h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: MOI
Basis:
mean
Remarks:
of 3 animals
Time point:
72 h
Score:
0
Max. score:
110
Reversibility:
other: not applicable
Irritation parameter:
other: AOI
Basis:
mean
Remarks:
of 3 animals
Time point:
24 h
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
The AOI was determined to be 6.0 at 24 hours and the MOI after 48 hours was 2.0, therefore, this test agent was determined to be slightly irritating based on the AFNOR (1982) criteria. No irritation was observed after 72 hours.

The Accident Value Test of Corneal Epithelium 24 hours after application was zero in all three animals.
Other effects:
There were no abnormalities in the general condition or the weight changes to any of the 3 animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The test agent was determined to be slightly irritating based on the AFNOR criteria. It does however not need to be classified for eye irritation according to the CLP criteria.
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Read across based on the study of the Chemical Evaluation and Research Institute (2000) with yttrium zirconium oxide and a study from Shapiro (1990) with erbium oxide. The read across justification document is attached in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
other: read across conclusion
Remarks on result:
other: Erbium zirconium oxide was concluded not to be irritant to eyes based on the read across studies from Shapiro (1990) with dierbium trioxide and the Chemical Evaluation and Research Institute (2000) with yttrium zirconium oxide.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

1. Information on zirconium dioxide (CAS# 1314-23-4)

Skin irritation / corrosion:

Based on to the available data and according to the criteria of the CLP Regulation, this substance should not be classified for skin corrosion / irritation.

Serious eye damage / irritation:

Based on the available data and according to the criteria of the CLP Regulation, this substance should not be classified for serious eye damage / irritation.

2. Information on erbium oxide (CAS# 12061-16-4)

Skin irritation / corrosion:

Based on to the available data and according to the criteria of the CLP Regulation, this substance should not be classified for skin corrosion / irritation.

Serious eye damage / irritation:

Based on the available data and according to the criteria of the CLP Regulation, this substance should not be classified for serious eye damage / irritation.

3. Conclusion on erbium zirconium oxide

Based on the data on the individual components in the 'solid solution', it can be concluded that erbium zirconium oxide is not irritating to skin or eyes and does not need to be classified for these endpoints.