[No public or meaningful name is available]

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

2 moles Ethoxylated bisphenol A methacrylate was examined for eye irritating properties according to the techniques of tests published by the FDA of the US and Draize and Kelley.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (1-methylethylidene)bis(4,1-phenyleneoxy-2,1-ethanediyl) bismethacrylate and 2-{4-[2-(4-{2-[2-(methacryloyloxy)ethoxy]ethoxy}phenyl)propan-2-yl]phenoxy}ethyl methacrylate

EC Number:

939-702-5

Molecular formula:

C23H24O4 (C2H4O)n

IUPAC Name:

Reaction mass of (1-methylethylidene)bis(4,1-phenyleneoxy-2,1-ethanediyl) bismethacrylate and 2-{4-[2-(4-{2-[2-(methacryloyloxy)ethoxy]ethoxy}phenyl)propan-2-yl]phenoxy}ethyl methacrylate

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Healthy adult rabbits.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye remaining untreated serves as a control

Amount / concentration applied:

One tenth of a milliliter of the test substance is allowed to fall on the overted lower lid of one eye of each rabbit; the upper and lower eye lid are then cared fully closed and subsequently held together for as least one second before releasing, to prevent loss of material.

Duration of treatment / exposure:

one administration

Observation period (in vivo):

24-48-72 hours and 7 fays after instillation of the test material.

Number of animals or in vitro replicates:

6

Details on study design:

The eyes are not washed following instillation and the animals are released immediately.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

6 rabbits

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Test substance did not elicit any detectable eye lesions.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not eye irritating

Conclusions:

2 moles Ethoxylated bisphenol A methacrylate did not elicit any detectable eye lesions; it is considered to be not irritating for eyes.

Executive summary:

2 moles Ethoxylated bisphenol A methacrylate was examined for eye skin irritating properties according to the Draize method.

0.1 mL of the test substance is allowed to fall on the eye. The eyes are not washed following instillation and the animals are released immediately. The eyes are examined at 24, 48, 72 hours and 7 fays after instillation of the test material.

2 moles Ethoxylated bisphenol A methacrylate did not elicit any detectable eye lesions; it is considered to be not irritating for eyes.