Registration Dossier
Registration Dossier
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EC number: 269-075-7 | CAS number: 68187-15-5 An inorganic pigment that is the reaction product of high temperature calcination in which praseodymium (III) oxide, praseodymium (IV) oxide, silicon oxide, and zirconium (IV) oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of zircon. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
Eye irritation
Administrative data
- 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:
- guideline study
- Remarks:
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- yes
- Remarks:
- , see "rational for reliability"
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zirconium praseodymium yellow zircon
- EC Number:
- 269-075-7
- EC Name:
- Zirconium praseodymium yellow zircon
- Cas Number:
- 68187-15-5
- Molecular formula:
- Pr(x)Zr(1-x)SiO4 0,03≤x≤0,09
- IUPAC Name:
- silicon(4+) zirconium(4+) λ⁴-praseodymium(4+) dipraseodymium(3+) nonaoxidandiide
- Test material form:
- solid
- Details on test material:
- - Name: Sicocer F Gelb 2214
- EC Name: Zirconium Praseodymium Yellow Zircon
- Substance type: inorganic pigment
- Physical state: solid, yellow powder, odourless
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- 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
Test system
- 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. - 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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
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