Zirconium oxide (ZrO2), erbium-doped

Endpoint summary

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

Reference

Reference 1

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

Reference 2

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.

Reference 3

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.

Reference 4

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

Reference

Reference 1

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. 

Reference 2

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.

Reference 3

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

Reference 4

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

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.