Registration Dossier
Registration Dossier
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EC number: 269-057-9 | CAS number: 68186-95-8 An inorganic pigment that is the reaction product of high temperature calcination in which zirconium (IV) oxide, silicon oxide, and vanadium (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:
- other: GLP guideline study reliable without restrictions
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:
- adopted 1987-02-24
- Deviations:
- yes
- Remarks:
- : scoring according to modified Draize system (different wording); it was not stated, if the eyes were examined within 24 hours before testing started; it was not stated, if the eyelids were held together after application of the test substance.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Zirconium vanadium blue zircon
- EC Number:
- 269-057-9
- EC Name:
- Zirconium vanadium blue zircon
- Cas Number:
- 68186-95-8
- Molecular formula:
- (Zr, V)SiO4
- IUPAC Name:
- silicon(4+) vanadium(4+) zirconium(4+) hexaoxidandiide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Sicocer F Tuerkis 2504
- Physical state: powder, blue
- Storage condition of test material: room temperature
- Homogeneity: the sample appeared to be homogenous
No further information on the test material was stated.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.60 kg - 2.82 kg
- Housing: 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; rabbits were housed singly
- Diet (about 130 g per animal per day): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (about 250 mL per animal per day): tap water
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study
ENVIRONMENTAL CONDITIONS - animals were housed in fully air-conditioned rooms.
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a single application of 0.1 mL bulk volume (about 138 mg of the comminuted test substance) was applied to the conjunctival sac of the right eyelid. The untreated eye served as control.
No further information on the amount/concentration applied was stated. - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the substance was not washed out.
SCORING SYSTEM: according to a modified Draize scale.
Chemosis and cornea (opacity-degree of density):
0 = none
1 = slight
2 = well-defined
3 = severe
4 = very severe
Conjunctivae redness:
0 = normal
1 = slight
2 = well-defined
3 = severe
Iris:
0 = normal
1 = circum-corneal injection
2 = iritis
Area of cornea involved:
1 = > 0; < 1/4
2 = >= 1/4; < 1/2
3 = >= 1/2; < 3/4
4 = >= 3/4
Discharge:
0 = normal
1 = slightly increased
2 = clearly increased
3 = distinctly increased
OBSERVATIONS:
Weight determination: shortly before application of the test substance.
Symptoms were recorded.
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- 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:
- 4
- Irritant / corrosive response data:
- Slight conjunctivae redness was observed in all animals at the 1 hour observation and in two animals at the 24 hour observation. Well-defined conjunctivae redness was observed in one animal at the 24 hour observation. Conjunctivae redness had fully reversed in all animals at the 48 hour observation.
Slightly increased discharge was only observed in all animals at the 1 hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sicocer F Tuerkis 2504 is not irritating to the eye.
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.
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