Registration Dossier
Registration Dossier
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EC number: 225-924-3 | CAS number: 5153-24-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Zirconium di(acetate) oxide
- EC Number:
- 225-924-3
- EC Name:
- Zirconium di(acetate) oxide
- Cas Number:
- 5153-24-2
- Molecular formula:
- C4 H6 O5 Zr
- IUPAC Name:
- zirconium di(acetate) oxide
- Details on test material:
- - Name of test material (as cited in study report): zirkon-acetat
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: 13-15 weeks
- Weight at study initiation: 2.2-2.7 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: pelleted standard Kliba 341, Batch 17/86 rabbit maintenance diet, ad libitum
- Water: community tap water from Itingen, ad libitum
- Acclimation period: 3 days under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as a negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 7, 14 and 21 days
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- After 21 days, the substance still produced corneal opacity (whole area, from slight to severe) and visible vascularization in all 3 animals. Slight redness of conjunctiva (score 1) was still observed after 21 days in one animal.
In the area of application no staining of the cornea and conjunctivae by pigment or coloring of the test article was observed. No corrosion of the cornea was observed at any of the measuring intervals. - Other effects:
- The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. Due to the results obtained, no macroscopic organ examination w as indicated.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information
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