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.
Skin irritation / corrosion
Administrative data
- 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:
- guideline study
- Remarks:
- 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.
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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981-05-12
- 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
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system 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
Test system
- 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. - 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
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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.
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 skin irritant.
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