Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1, 1992 - September 29, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
Short-term Toxicology CIBA-GEIGY Limited

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid; white
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2500 to 2690 g
- Housing: individually in metal cages
- Diet: ad libitum, standard rabbit pellet - Nafag No. 814
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
other: substance was applied as such
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (60 mg)
- Concentration (if solution): 600mg/ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
1, 24, 48, 72 hours, 7, 10, 14 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to OECD 405

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:
0.9
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2.9
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
In all animals the mucosa of the conjuntival sac appeared strongly damaged at the readings 24, 48, and 72 hours (two animals) or only at the readings 48 and 72 hours (one animal) after instillation of the test article. In one animal a slight vascularisation of the lower marginal part of the cornea was observed from day 7 until day 10.

Any other information on results incl. tables

Individual eye scores

conjunctiva
reading animal cornea iris redness chemosis sympomts
1h 1 1 1 1 1
2 1 1 2 2
3 1 1 2 2
24h 1 1 1 2 1
2 0 1 3 1
3 2 1 3 1
48h 1 1 1 3 1
2 0 1 3 1
3 2 1 3 1
72h 1 0 0 3 1
2 0 0 3 1
3 2 1 3 1
7 d 1 0 0 1 0
2 0 0 2 0
3 0 0 2 0 vascularisation
10d 1 0 0 0 0
2 0 0 1 0
3 0 0 1 0 vascularisation
14d 1 - - - -
2 0 0 0 0
3 0 0 0 0
mean 24-72h 1 0.7 0.7 2.7 1.0
2 0.0 0.7 3.0 1.0
3 2.0 1.0 3.0 1.0
mean 24-72h 0.9 0.8 2.9 1.0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance caused irritation reactions in the rabbot eye triggering classification.