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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Oxybis(methyl-2,1-ethanediyl) diacrylate
EC Number:
260-754-3
EC Name:
Oxybis(methyl-2,1-ethanediyl) diacrylate
Cas Number:
57472-68-1
Molecular formula:
C12H18O5
IUPAC Name:
oxydipropane-1,2-diyl bisacrylate
Details on test material:
- Name of test material (as cited in study report): UCB DPGDA
- Physical state: clear colourless liquid
- Analytical purity: no data given
- Lot/batch No.: 80311858
- Storage condition of test material: at room temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: individually in suspended cages; bedding was placed beneath the cages and changed at least 3 times a week
- Diet: Freah Purina Rabbit Chow (Diet # 5321) was provided daily
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 h light-dark cycle and was kept clean and vermin free.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the same animal served as control
Amount / concentration applied:
One eye of each rabbit was dosed. The contralateral eye served as a control. The test article (0.1 ml) was placed by syringe into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to ensure adequate distribution of the test article.
Duration of treatment / exposure:
the substance was not washed out
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6 animals
Details on study design:
Using a Mini-Maglite flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48, and 72 hours post dose. Sodium fluorescein was used to determine corneal effeets following the 24 hour scoring interval. The eyes were scored again on days 7, 14 and 21. Ocular reaetions were graded aceording to the numerical Draize technique. Additional signs were described.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
2.16
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
3.11
Max. score:
4
Reversibility:
not fully reversible within: 21 days

Any other information on results incl. tables

Table 1: individual scores of the animals at different reading time points:

 

1 hour

24 hours

48 hours

72 hours

7 days

14 days

21 days

Animal 1

cornea

0

2

2

2

2

0

0

iris

0

1

1

1

0

0

0

conjunctiva

1

2

2

2

1

0

0

chemosis

2

2

4a

4ab

2e

0e

0

Animal 2

cornea

0

2

2

2

2

2c

2c

iris

1

1

1

1

1

1

0

conjunctiva

1

2

3

3

2

1

0

chemosis

2

3

4a

4a

3e

2e

0

Animal 3

cornea

0

2

2

2

2

2c

2c

iris

1

1

1

1

1

0

0

conjunctiva

1

2

2

2

1

0

0

chemosis

2

3

3a

3a

2e

0e

0

Animal 4

cornea

0

2

2

2

2c

0

0

iris

0

1

1

1

0

0

0

conjunctiva

1

2

2

2

1

0

0

chemosis

2

2

2a

2

2

0e

0

Animal 5

cornea

0

2

2

2

4

4cg

4cg

iris

0

1

1

1

1

1

1

conjunctiva

1

2

2

3

3

3

1

chemosis

2

3

4a

4a

3e

2e

2

Animal 6

cornea

0

2

2

2

3c

2c

2c

iris

0

1

1

1

1

0

0

conjunctiva

1

2

2

2

2

0

0

chemosis

2

3

3a

3a

2

2

0

a = white discharge

c = pannus

e = alpecia around dosed eye

g = raised area on cornea

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information