Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 22-12-1994 to 25-12-1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study performed according to OECD Guideline 405 without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): zirconium basic sulfate
- Substance type: whitish powder
- Physical state: solid
- Analytical purity: 37.2% ZrO2 (loss on ignition), 0.22% SiO2/SBZ dry
- Purity test date: 13 December 1994
- Lot/batch No.: 4151829
- Storage condition of test material: room temperature
- Other: date received: 15-12-1994 and provided by Thann et Mulhouse
- Other: The pH of the product at a concentration of 10% in water is 2.2.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: Animals are housed individually in polystyrene cages with a food and water supply system
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
The substance is not rinsed from the eye until the end of the 72 h treatment.
Observation period (in vivo):
at 1, 24, 48 and 72 hours after product administration
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE: not performed

SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: fluorescein / UV lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean score
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
Only slight ocular reactions were observed during 48 hours after treatment. No effect was noted 72 hours after treatment. The mean score over 24, 48 and 72 hours for each animal was 0.0, 0.0 and 0.3 for chemosis, 1.0, 0.7 and 1.0 for redness of the conjunctiva and 0.0 for iris and cornea.
Other effects:
Tearing was observed in 2 animals at 1 hour after application, which was reversible within 24 hours.
A purulent whitish matter was present in the eye of the third animal 1 day after administration, and was gone the day after.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this test, zirconium basic sulfate was considered non-irritant when administered by ocular route in rabbits.