Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according GLP and OECD guideline, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Wistar
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 11-12 weeks
- Housing: single
- Diet d libitum
- Water d libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Observation period (in vivo):
Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application
Number of animals or in vitro replicates:
3
Details on study design:
The test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.

SCORING SYSTEM: according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
and #2
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
other: opacitiy, due to staining by the test item
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the iris of any animal at any of the examinations. The slight opacity of the whole corneal area at the 1-hour reading was provoked by the test item staining. No corrosion was observed at any of the measuring intervals.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
Slight staining of the treated eyes produced by the test item was observed in all animals at the 1-hour reading and in two animals at the 24-hour reading. Red test item remnants were evident in all animals at the 1-hour reading.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU