Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
6 animals used instead of 3
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeding center Padre Antonio, Italy
- Weight at study initiation: 2 - 3 kg
- Housing: Stainless steel cages
- Diet (ad libitum): Pelleted complete diet
- Water (ad libitum): Tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 55 +/- 15
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were not washed.

SCORING SYSTEM:
Draize Scoring

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.83
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72, h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

Table 1: Individual scorings

Observation

Observation time

Animal No

 

1

2

3

4

5

6

Mean

Men 24, 48, 72 h

Cornea

1 h

0

0

0

0

0

0

0.0

-

 

24 h

0

0

0

0

0

0

0.0

0.0

 

48 h

0

0

0

0

0

0

0.0

 

72 h

0

0

0

0

0

0

0.0

 

7 d

0

0

0

0

0

0

0.0

-

Iris

1 h

0

0

0

0

0

0

0.0

-

 

24 h

0

0

0

0

0

0

0.0

0.0

 

48 h

0

0

0

0

0

0

0.0

 

72 h

0

0

0

0

0

0

0.0

 

7 d

0

0

0

0

0

0

0.0

-

Redness

1 h

2

2

2

2

2

1

1.8

-

 

24 h

2

2

1

2

1

1

1.5

0.83

 

48 h

1

1

1

1

1

1

1.0

 

72 h

0

0

0

0

0

0

0.0

 

7 d

0

0

0

0

0

0

0.0

-

Chemosis

1 h

2

2

1

2

1

1

1.5

-

 

24 h

1

1

1

1

1

1

1.0

0.5

 

48 h

1

1

1

0

0

0

0.5

 

72 h

0

0

0

0

0

0

0.0

 

7 d

0

0

0

0

0

0

0.0

-

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.