1,4-butanediyl diacrylate

Eye irritation

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

Test material information

Constituent 1

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:

4-(prop-2-enoyloxy)butyl prop-2-enoate

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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