Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-03-12 to 1985-03-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 405), according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted on May 12, 1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid, insoluble in water
- Analytical purity: commercial grade

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
- The test was performed on 3 male New Zealand white rabbits (KFM-NZW), checked for normal ophthalmic conditions within 24 hours before start of test.
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: approx. 12-14 weeks
- Weight at study initiation: 2 to 3 kg
- Housing: Individually in metal cages, identified with individually numbered ear tags
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C
- Humidity: Relative humidity of 30-70 %
- Photoperiod: 12 hours light cycle day

All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results are available at the animal supply office. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). Results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to Ciba-Geigy Ltd., as well as the results of in house chemical analysis by the analytical laboratories of the Pharmaceuticals Division, Ciba-Geigy Ltd.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 females
Details on study design:
- SCORING SYSTEM: according to OECD and EEC commission directive No. 83/467, 1983
- TOOL USED TO ASSESS SCORE: hand-slit lamp
- Time after start of exposure: The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of test item.

0.1 g of test item was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The animals were checked daily for systemic symptoms and mortality.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs (mean)
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs (mean)
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs (mean)
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
All three animals showed minimal to mild signs of erythema starting at the 1 hour time point. This effect reversed to normal after 72 hours the latest. In addition, all three animals showed minimal chemosis at the 1 hour time point only.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance caused only minimal ocular reactions below the level of regulatory significance and is therefore classified as not irritating to the rabbit eye.
Executive summary:

In a GLP-compliant eye irritation study performed according to OECD guideline 405, three New Zealand White rabbits were treated with 0.1 g of the test article. The test article was placed into the conjunctival sac of the right eye of each animal; the lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after instillation and animals were checked daily for signs of systemic toxicity. Under the experimental conditions employed the test article induced minimal to mild conjunctival reactions well below the threshold of significance. All signs of irritation disappeared within 72 hours the latest. The test article is therefore classified as not irritating.