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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well documented study report which meets basic scientific principles

Data source

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

Materials and methods

Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Palatinol N

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: GAUKLER 6050 OFFENBACH / MAIN
- Housing: 1 animal/cage
- Diet (e.g. ad libitum): OVATOR SOLIKANIN 4 MM ; MUSKATOR-WERKE 4000 DUESSELDORF-1 (daily about 130 G/animal)
- Water (e.g. ad libitum): daily about 250 ML/animal:
- Acclimation period: about 8 days before start of study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 50 - 80 %
- Photoperiod (hrs dark / hrs light): 12 H/12 H (6.00 - 18.00 H/18.00 - 6.00 H)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml, single application into the conjunctival sac of the right eye, the substance is not washed off
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
2 males, 4 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72H
Score:
0
Max. score:
4
Reversibility:
other: n.a.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72H
Score:
0
Max. score:
2
Reversibility:
other: n.a.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72H
Score:
0.28
Max. score:
3
Reversibility:
fully reversible within: 2 days

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

24 h

1

0

0

0

1

0

0

 

2

0

0

0

1

0

0

 

3

0

0

0

1

0

0

 

4

0

0

0

1

0

0

 

5

0

0

0

0

0

0

 

6

0

0

0

1

0

0

 

48 h

1

0

0

0

0

0

0

 

2

0

0

0

0

0

0

 

3

0

0

0

0

0

0

 

4

0

0

0

0

0

0

 

5

0

0

0

0

0

0

 

6

0

0

0

0

0

0

 

72 h

1

0

0

0

0

0

0

 

2

0

0

0

0

0

0

 

3

0

0

0

0

0

0

 

4

0

0

0

0

0

0

 

5

0

0

0

0

0

0

 

6

0

0

0

0

0

0

 

Mean

24-72 h

1-6

0

0

0

0.28

0

0

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU