Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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: according to information in OECD SIDS (2002)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976
Reference Type:
publication
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
; 50 mg instead of 100 mg test substance instilled
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): THEIC
- Physical state: solid
- Analytical purity: ca. 99%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler (breeder)
- Weight at study initiation: 2.98 and 3.09 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 50 mg talcum into the other eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
50 mg into the conjunctival sac of one eye per rabbit. The contralateral eye received 50 mg talcum to serve as a control.
Duration of treatment / exposure:
Once. There was no mentioning in the raw data or report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 8 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
Observation period (in vivo):
8 days (observations at 10 min, 1 h, 3h, 1, 2, 3, 4, 7 and 8 days post instillation)
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
Descriptive grading in the raw data: no effect / questionable / slight / strong / very strong.
In addition, indication of the type of finding as appropriate: erythema / edema / scale formation / necrosis / opacity / scar.
The descriptive scores in the raw data were converted into OECD/ Draize scores.

FLUORESCEIN:
On day 8 staining with fluorescein to support eye evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
Secretion was noted in one animal at 10 min post instillation in the other animal at 1 h post instillation, but was no longer seen thereafter.

Any other information on results incl. tables

 

Animal 

Reading 

Opacity

Iritis

Redness

Chemosis

Comment

1

 1 h

0

0

1

0

Secretion

2

 1 h

0

0

1

0

1

24 h

0

0

0

0

 

2

24 h

0

0

0

0

 

1

48 h

0

0

1

0

 

2

48 h

0

0

1

0

 

1

72 h

0

0

1

0

 

2

72 h

0

0

1

0

 

1

4 d

0

0

1

0

 

2

4 d

0

0

1

0

 

1

7 d

0

0

1

0

 

2

7 d

0

0

1

0

 

1

8 d

0

0

1

0

score before application of fluorescein

2

8 d

0

0

0

0

score before application of fluorescein

1

8 d

0

0

0

0

score after application of fluorescein

2

8 d

0

0

0

0

score after application of fluorescein

mean

24 - 72 h

0.00

0.00

0.67

0.00

 

Applicant's summary and conclusion

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