Registration Dossier

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other: Non-GLP guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): zirkon-acetat
- Physical state: liquid

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