Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted April 24, 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
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: males: 13 weeks; females: 14 - 15 weeks
- Weight at study initiation: male: 2760 g; females: 2581 g and 2486 g
- Housing: Individually in stainless steel cages
- Diet: standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

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

IN-LIFE DATES: 05.11. - 28.11.2002

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
7 days (examination of the eyes after 1 hour and 1, 2, 3, 7, 10 and 14 days after instillation of the test substance)
Number of animals or in vitro replicates:
1 male and 2 female NZW rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
The treated eyes were not rinsed after instillation.

SCORING SYSTEM:
According to the grading system given in the OECD guideline 405

TOOL USED TO ASSESS SCORE:
Eye examinations were made with a Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean (24, 48, 72h)
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean (24, 48, 72h)
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean (24, 48, 72h)
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean (24, 48, 72h)
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean (24, 48, 72h)
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean (24h, 48h, 72h)
Score:
0.89
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean (24, 48, 72h)
Score:
0
Max. score:
4
Irritant / corrosive response data:
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening of the conjunctivae was observed in all animals from 1 to 48 hours after treatment. This effect continued to be observed in one animal up to the 72-hour examination and in another animal up to the 7-day examination. Slight swelling of the conjunctivae was apparent in all animals at the 1-hour examination. Slight reddening of the sclerae was present in one animal from 1 to 24 hours after treatment and in another animal at the 1-hour examination only. Prolonged scleral reddening (slight) was noted in the remaining animal from 1 hour to 14 days after treatment. No abnormal findings were observed in the treated eye of any animal 17 days after treatment, the end of the observation period for all animals.

Other effects:
COLORATION
No staining of the treated eyes by the test item was observed. Green remnants of the test item were observed in the eye or conjunctival sac of all animals 1 hour after treatment.

Applicant's summary and conclusion

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