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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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- Observation period 7 days;
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-butanediyl diacrylate
EC Number:
213-979-6
EC Name:
1,4-butanediyl diacrylate
Cas Number:
1070-70-8
Molecular formula:
C10H14O4
IUPAC Name:
1,4-butanediyl diacrylate
Details on test material:
- Name of test material (as cited in study report): Butanedioldiacrylate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals are caged individually and receive no hay or other extraneous material that might enter the eyes .

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material .
Number of animals or in vitro replicates:
6
Details on study design:
In general the techniques of tests as published by the FDA of the United States (Fed . Reg . 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet . Industr . 71 (1952) 36) were followed . Six New Zealand White albino rabbits were used . The animals were caged individually and receive no hay or other extraneous material that might enter the eyes . The eyes of the animals were examined before testing and only those animals without observable eye defects were used . One tenth of a milliliter of the test substance was allowed to fall on the everted lower lid of one eye of each rabbit ; the upper and lower eye lid were then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material . The other eye remained untreated and served as a control . The eyes were not washed following instillation, and the animals were released immediately .

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72
Score:
0.7
Max. score:
2
Reversibility:
other: day 7: one animal had Draize score 1; all other 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72
Score:
2.1
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days

Any other information on results incl. tables

Draize scores of individual animals

 

time

animal 1

animal 2

animal 3

animal 4

animal 5

animal 6

corneal opacity

24 h

2

1

1

1

1

1

48 h

1

1

1

1

1

2

72 h

2

1

1

2

2

2

7 d

1

3

0

2

3

3

iris

24 h

1

1

1

1

1

1

48 h

0

0

0

1

1

1

72 h

0

1

0

1

1

1

7 d

0

0

0

0

0

1

conjunctiva

erythema/edma

redness / chemosis

24 h

2/4

2/3

2/3

2/3

2/3

2/3

48 h

3/4

2/2

2/3

2/2

2/2

2/2

72 h

2/3

2/2

2/2

2/2

2/2

2/2

7 d

2/2

2/2

1/0

2/2

2/2

2/2

Applicant's summary and conclusion

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