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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed under GLP and in accordance with OECD-/EU-testing guidelines
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Substance number: 94/243
- Physical state & aspect: Liquid, yellowish
- Storage condition of test material: refrigerator

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, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.69-3.93 kg
- Housing: single housing in stainless steel wire mesh cages, no bedding
- Diet (e.g. ad libitum): Kliba-Labordiät 341, Klingenthalmühle AG; Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tab water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 h darkness; 12 h continuous light

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
the substance was applied as such
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Readings 1 h, 24 h, 48 h and 72 h after application
Observation period (in vivo):
Obervation period was 72 hours
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The test item solution was applied to the conjunctival sac of the right eyelid; eyes were not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Reversibility:
fully reversible within: 2 d
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
Clinical signs or other effects were not observed

Applicant's summary and conclusion

Interpretation of results:
other: the aqueous solution does not have any classification/labelling requirements; for the concentrated test material there are no test results available, therefore a final classification for this quality can not be made.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The aqueous solution was found to be non-irritating to the rabbit eye; for the concentrated test material there are no test data available.
Executive summary:

The test was performed 1995 under GLP according to the EU standard testing method B.5 (Directive 67/548/EEC). The study was performed on 3 male rabbits. 0.1 ml test item solution was applied to the conjunctival sac of the test animals. Redness with score 1 -2 was observed in all three animals, however this finding was reversible within 48 hours. There were neither chemosis and nor other effects on cornea and iris seen.