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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
Study period:
Sep 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited data
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: not reported
- Lot/batch No.: 2403 L

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
other: the untreated eye served as control
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable

Any other information on results incl. tables

Results:

 

 

Cornea

Iris

Conjunctiva

Reading time

Animal No.

Opacity

Area of opacity

Redness

Chemosis

Discharge

1 h

6599

0

0

1

2

0

2

6600

0

0

0

2

1

2

6601

0

0

1

2

1

2

24 h

6599

0

0

0

1

0

0

6600

0

0

0

1

0

0

6601

0

0

0

1

0

0

48 h

6599

0

0

0

1

0

0

6600

0

0

0

0

0

0

6601

0

0

0

1

0

0

72 h

6599

0

0

0

1

0

0

6600

0

0

0

0

0

0

6601

0

0

0

0

0

 

mean 24-48-72 h

6599

0.0

0.0

0.0

1.0

0.0

0.0

6600

0.0

0.0

0.0

0.3

0.0

0.0

6601

0.0

0.0

0.0

0.7

0.0

0.0

mean

0.0

0.0

0.0

0.7

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
CLP: not classified
DSD: not classified