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Diss Factsheets

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: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
one eye washed after 20 seconds
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
trans-dichloroethylene
EC Number:
205-860-2
EC Name:
trans-dichloroethylene
Cas Number:
156-60-5
Molecular formula:
C2H2Cl2
IUPAC Name:
(1E)-1,2-dichloroethene
Details on test material:
-Purity: 99.64%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2806 and 3289 grams
- Housing: housed singly in suspended, stainless steel, wire-mesh cages
- Diet: Purina Certified Rabbit Chow® #5322 (ad libitum)
- Water: ad libitum
- Acclimation period: approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): targeted for a temperature of 20°C ± 2°C
- Humidity (%): 50% ± 10%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 mL aliquot
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1 and 4 hours and 1, 2, and 3 days following administration
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): one rabbit had eyes washed
- Time after start of exposure: 20 seconds

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: biomicroscope, fluorescein, Hemastix® reagent strips

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: discharge
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: unwashed
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: washed eye
Irritation parameter:
conjunctivae score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: washed eye
Irritation parameter:
chemosis score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed eye
Irritation parameter:
other: discharge
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: washed eye
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 4
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: washed eye
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: unwashed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 1 Hour
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 4 Hours
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 1
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: unwashed
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 1 Hour
Score:
1
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 4 Hours
Score:
1
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 2
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 1 Hour
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 4 Hours
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
>= 0 - <= 2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: unwashed
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 1 Hour
Score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
other: 4 Hours
Score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
24 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Unwashed Eye
Time point:
72 h
Score:
0
Irritant / corrosive response data:
The test substance produced severe corneal opacity in the washed eye. In addition, it produced moderate iritis and conjunctival redness and copious blood-tinged discharge (confirmed with Hemastix® reagent strips) in both treated eyes, and moderate and mild chemosis in the washed and unwashed eye, respectively. Fluorescein stain examinations were positive for corneal injury in the washed eye and negative in the unwashed eye. Biomicroscopic examinations revealed moderate to severe corneal injury in the washed eye and no corneal injury in the unwashed eye. The treated eyes of both rabbits were normal by 3 days after treatment.

Any other information on results incl. tables

Unwashed Rabbit Eye

Time

1

Hour

4

Hours

1

Day

2

Days

3

Days

Corneal

Opacity

0

0

0

0

0

Iris

1

1

0

0

0

Redness

1

2

2

1

0

Chemosis

2

2

0

0

0

Discharge

3(H+)

2(H+)

0

0

0

Biomic of Cornea

-

-

0

0

0

H+ = Hemastix® evaluation positive for blood.

Fluorescein examinations: negative for corneal injury

at all intervals

Washed Rabbit Eye

Time

1

Hour

4

Hours

1

Day

2

Days

3

Days

Corneal

Opacity

1

2

4

1

0

Iris

1

1

1

0

0

Redness

1

2

2

1

0

Chemosis

3

3

1

1

0

Discharge

3(H+)

3(H+)

0

0

0

Biomic of Cornea

-

-

4

2

0

H+ = Hemastix® evaluation positive for blood.

Fluorescein examinations: positive for corneal injury 1 day after treatment.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Under the conditions of this study, the test item was an eye irritant.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 2 young adult New Zealand white rabbits. An aliquot of 0.01 mL of the test substance was administered to 1 eye of each animal. The eyes of one rabbit were washed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to the Draize scale approximately 1 and 4 hours and 1, 2, and 3 days following administration.

The substance produced severe corneal opacity in the washed eye. In addition it produced moderate iritis and conjunctival redness and copious blood-tinged discharge (confirmed with Hemastix® reagent strips) in both treated eyes, and moderate and mild chemosis in the washed and unwashed eye, respectively. Fluorescein stain examinations were positive for corneal injury in the washed eye and negative in the unwashed eye. Biomicroscopic examinations revealed moderate to severe corneal injury in the washed eye and no corneal injury in the unwashed eye. The treated eyes of both rabbits were normal by 3 days after treatment. Under the conditions of this study, the test item was an eye irritant.