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Administrative data

Description of key information

Zirconium praseodymium yellow zircon has been tested in one in vivo skin irritation and one eye irritation study. All tests show a negative response, thus zirconium praseodymium yellow zircon does not require classification either  as skin or as eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study reliable without restrictions Minor deviations from the guideline withhout effect on the results: - According to the guideline, approx. 24 h before the test the fur should be removed by clipping or shaving. In this study it was only stated that the fur was clipped at least 15 h before the beginning of the test. - According to the guideline, the examination for erythema and oedema should take place at 30 - 60 minutes, and then at 24, 48, 72 h after patch removal. In this study the examination took place at 30 -60 minutes after removal of the test patches and 24 h, 48 h, 72 h after the beginning of application. - A modified Draize scoring system was used. - The readings of skin reaction at 30 - 60 minutes were missing in the test report. Instead a reading at 4 hours was mentioned.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, adopted 1981-05-12
Deviations:
yes
Remarks:
see "rational for reliability"
GLP compliance:
yes
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach/Main, FRG
- Average weight at study initiation: Female rabbit: 2.45 kg; male rabbit: 3.08 kg; male rabbit: 3.23 kg
- Housing: Individual housing of rabbits; Cage made of stainless steel with wire mesh walk floors; Floor area: 40 cm X 51 cm; No bedding in the cages; Sawdust in the waste trays
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG; CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test patch (2.5 cm X 2.5 cm) was covered with a dose of 0.5 g of the unchanged test substance and has been moistened with aqua. bidest.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (Readings at 30 -60 minutes after removal of the test patches and 24 hours, 48 hours, 72 hours after the beginning of application)
Number of animals:
1 male /2 females
Details on study design:
TEST SITE
- Area of exposure: Application area was 2.5 cm X 2.5 cm. The application site was the upper third of the back or flanks. The untreated skin sites of the animals served as negative control.
- Type of wrap if used: Test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: At the end of the exposure period

SCORING SYSTEM: A modified Draize scoring system was used.
Evaluation of erythema and oedema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe
No further information on the study design was stated.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritant / corrosive response data:
At the 24 hour reading very slight erythema was observed in the two male rabbits.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study reliable without restrictions Minor deviations from the guideline without an effect on the results: - According to the guideline, both eyes should be examined regarding eye problems 24 hours before the test. It was not stated, if this was done in this study. - According to the guideline, after the substance has been placed in the conjunctival sac the eyelids are gently held together for about 1 second. This statement was missing in the report. - Scoring according to modified Draize system (different wording). -According to the guideline, a narrative description of the degree and nature of irritation or corrosion should be given, which was missing in the report.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, adopted 1987-02-24
Deviations:
yes
Remarks:
, see "rational for reliability"
GLP compliance:
yes
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach / Main, FRG.
- Weight at study initiation: average weight: 2.93 kg rabbit #1 (female); 2.84 kg rabbit #2 (female); 3.25 kg rabbit #3 (male)
- Housing: The animals were housed individually. Cage made of stainless steel with wire mesh walk floors, Floor area: 40 cm X 51 cm; No bedding in the cages; Sawdust in the waste trays
- Diet: Kliba 341, 4MM; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 ml tap water per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No furthre information on the test animals was stated.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 110 mg of the comminuted test substance) was applied in a single application to the conjunctival sac of the right eyelid. The untreated eye served as negative control.
No further information on the amount/concentration applied was stated.
Observation period (in vivo):
72 hours (Readings at 1 hour; 24 hours; 48 hours and 72 hours after application)
Number of animals or in vitro replicates:
one male / two females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The substance was not washed out

SCORING SYSTEM: Scoring according to a modified Draize system
Chemosis (SW) and cornea (OP) (Opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe
Conjunctivae redness (RED):
0 = normal
1 = slight
2 = well-defined
3 = severe
Iris:
0 = normal
1 = circum-corneal injection
2 = iritis
Area of cornea invoolved (AR):
1 = > 0; < 1/4
2 = >= 1/4; < 1/2
3 = >= 1/2; < 3/4
4 = >= 3/4
Discharge (DI):
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased
No further information on the study design was stated.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
At the 1-hour observation well-defined conjunctivae redness was observed in all rabbits. In addition, in one rabbit well-defined chemosis and in two rabbits slight chemosis was observed. Clearly increased discharge could be observed in all rabbits at the 1-hour observation. All ocular effects, except for conjunctivae redness, disappeared within 24 hours.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

One study on skin irritation according to OECD TG 404 has been performed that indicated at the 24 hour reading very slight erythema in two male rabbits.

One study on eye irritation according to OECD TG 405 has been performed. At the 1-hour observation well-defined conjunctivae redness was observed in all rabbits. In addition, in one rabbit well-defined chemosis and in two rabbits slight chemosis was observed. Clearly increased discharge could be observed in all rabbits at the 1-hour observation. All ocular effects, except for conjunctivae redness, disappeared within 24 hours.

Justification for classification or non-classification

Skin irritation

erythema, mean animal #1, 24 -72h after application: score=0.0

edema, mean animal #1, 24 -72h after application: score=0.0

erythema, mean animal #2, 24 -72h after application: score=0.33       (fully reversible within 48h)

edema, mean animal #2, 24 -72h after application: score=0.0

erythema, mean animal #3, 24 -72h after application: score=0.33       (fully reversible within 48h)

edema, mean animal #3, 24 -72h after application: score=0.0

The classification criteria acc. to regulation (EC) 1272/2008 as irritating to skin are not met since the mean erythema score in 2/3 animals was 0.33, hence no classification required.

According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant. According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.

Eye irritation

conjunctivae score, mean animal #1, 24 -72h: score=1.0              (fully reversible within 72h)

conjunctivae score, mean animal #2, 24 -72h: score=1.0              (fully reversible within 72h)

conjunctivae score, mean animal #3, 24 -72h: score=0.33            (fully reversible within 48h)

cornea score, mean animal #1, 24 -72h: score=0

cornea score, mean animal #2, 24 -72h: score=0

cornea score, mean animal #3, 24 -72h: score=0

iris score, mean animal #1, 24 -72h: score=0

iris score, mean animal #2, 24 -72h: score=0

iris score, mean animal #3, 24 -72h: score=0

chemosis score, mean animal #1, 24 -72h; score=0

chemosis score, mean animal #2, 24 -72h; score=0

chemosis score, mean animal #3, 24 -72h; score=0

The classification criteria acc. to regulation (EC) 1272/2008 as irritating to eyes are not met since the mean score in 2/3 animals was 1.0, hence no classification required.

According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as eye irritant. According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.

Respiratory irritation

The classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) for further information.