Registration Dossier

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:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: >99%
- Lot/batch No.:S1943401
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
Observation period (in vivo):
examination of the eyes after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after instillation
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24+48+72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24+48+72h
Score:
0.11
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24+48+72h
Score:
1.44
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24+48+72h
Score:
0.89
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

 

time

animal 1

animal 2

animal 3

corneal opacity

24 h

1

2

1

48 h

1

2

1

72 h

1

1

2

iris

24 h

0

0

0

48 h

0

0

0

72 h

0

0

1

conjunctivae

24 h

1

2

2

48 h

1

1

1

72 h

1

2

2

chemosis

24 h

1

2

1

48 h

0

1

1

72 h

0

1

1

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Single instillation into the eye elicited corneal opacities in all 3 animals accompanied by temporary iritis in one animal and conjunctival irritation in all 3 animals. All reactions had resolved 21 days after instillation.