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

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
Fed. Reg. 38, No. 187, § 1500.42
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Anisaldehyd
- Physical state: liquid
- Analytical purity: > 99 % (data from order sheet)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3.16 kg; mean of 2 females: 2.46 kg
- Diet (e.g. ad libitum): Ssniff, Intermast

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The substance was not washed out. Single treatment
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein (only at the final reading)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
all animals
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
all animals
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48 -72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Remarks:
all animals
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Animal 

Reading 

Opacity

Iritis

Redness

Chemosis

Discharge

1

1 h

0

0

2

1

2

2

1 h

0

0

2

1

2

3

1 h

0

0

2

2

2

1

24 h

0

0

1

0

1

2

24 h

0

0

1

0

1

3

24 h

0

0

1

0

1

1

48 h

0

0

0

0

0

2

48 h

0

0

1

0

0

3

48 h

0

0

0

0

0

1

72 h

0

0

0

0

0

2

72 h

0

0

0

0

0

3

72 h

0

0

0

0

0

1

24-48-72 h

0

0

0.33

0

 

2

24-48-72 h

0

0

0.67

0

 

3

24-48-72 h

0

0

0.33

0

 

Applicant's summary and conclusion