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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: - Guideline study with acceptable restrictions (e.g. study conducted comparable to current guideline, purity of substance not reported, very limited information on animal source and housing)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in-house breeding facility
- Age at study initiation: not reported
- Weight at study initiation: 2 - 3 kg
- Housing: 1 per cage (metal cages)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2
- Humidity (%): 55 +- 10
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Observation period (in vivo):
- 4 days
Number of animals or in vitro replicates:
1 animal per experimental procedure
Details on study design:
- 0.1 g of the test item was inserted in the conjunctival sac of the left eye of the rabbits and the lids were closed gently for a few seconds
- in one of the two rabbits (animal no. 182) approximately 30 sec after treatment the treated eye was flushed with 10 ml physiological saline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 181, not rinsed
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
other: animal killed for humane reasons after 4 days
Irritation parameter:
iris score
Basis:
animal: 181, not rinsed
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
other: animal killed for humane reasons after 4 days
Irritation parameter:
chemosis score
Basis:
animal: 181, not rinsed
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
other: animal killed for humane reasons after 4 days
Irritation parameter:
conjunctivae score
Basis:
animal: 181, not rinsed
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: animal killed for humane reasons after 4 days
Irritation parameter:
cornea opacity score
Basis:
animal: 182, rinsed
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: animal killed for humane reasons after 4 days
Irritation parameter:
iris score
Basis:
animal: 182, rinsed
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
other: animal killed for humane reasons after 4 days
Irritation parameter:
conjunctivae score
Basis:
animal: 182, rinsed
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
other: animal killed for human reasons after 4 days
Irritation parameter:
chemosis score
Basis:
animal: 182, rinsed
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
other: animal killed for humane reasons after 4 days
Irritant / corrosive response data:
see table 1
Other effects:
not reported

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this eye irritation study an average cornea opacity of 3, an average iris score of 2, an average chemosis score of 3 and an average conjunctiva redness score of 3 for the animale with rinsed eyes was determined. For the animal with not rinsing of the treated eye 30 seconds after treatment an average cornea opacity of 1.3, an average iris score of 0.66, an average chemosis score of 2 and an average conjunctiva redness score of 3 could be demonstrated. The animal with the eye not rinsed after treatment showed more potent effects and thus represents the worst case. Based on the results it can be concluded that the test substance has irritating effects on the eye of rabbits.