[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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:

Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin albino rabbits.

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Healthy adult rabbits.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact skin

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

An amount of 0.5 ml of the tes substance is brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch.

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours after application.

Number of animals:

12 (6 with abraded skin, and 6 with intact skin)

Details on study design:

The patches are fiwed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours after application).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits with intact skin

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: (intact skin) 5 animals out of 6 have an erythema score of 1 at 24 hours.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbits with intact skin

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: (intact skin) No oedema observed in all the animals.

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 rabbits with abraded skin

Time point:

24/48/72 h

Score:

1.1

Max. score:

4

Reversibility:

no data

Remarks on result:

other: (abraded skin) Maximal score of 2 is observed at 24 hours in 5 rabbits.

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 rabbits with abraded skin

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: (abraded skin) no oedema observed in all the animals.

Irritant / corrosive response data:

The two products examined caused very slight skin irritation on the intact skin and slight irritation on the abraded skin.
After 72 hours no dermal effects were detectable on the intact application sites. Only two out of 6 animals treated on the abraded skin showed very slight scaliness of the treated skin.

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not skin irritating

Conclusions:

Based on the results on intact skin, 2 moles Ethoxylated bisphenol A methacrylate is considered to be not skin irritating.

Executive summary:

2 moles Ethoxylated bisphenol A methacrylate was examined for primary skin irritating properties. Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin albino rabbits. After an exposure period of 24 hours, the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later.

Based on the results on intact skin, 2 moles Ethoxylated bisphenol A methacrylate is considered to be not skin irritating.