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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

2 moles Ethoxylated bisphenol A methacrylate was examined for primary skin and eye irritating properties in experiments with albino rabbits (TNP 1975) : the substance is not irritating for skin or eyes.


 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Healthy adult rabbits.
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).
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.
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.
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy adult rabbits.
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.
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation (TNO 1975)


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.


 


Eye irritation (TNO 1975)


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.

Justification for classification or non-classification

Based on the available data, no classification for skin or eye irritation is required for 2 modes ethoxylated bisphenol A dimethacrylate according to the Regulation EC N°1272/2008.