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Administrative data

Description of key information

Two reliable studies (Parcell 1993) are available to evaluate the skin and eye irritation potential of Bisphenol A ethoxylate diacrylate (read-across). The substance is not irritating for skin and eyes. 
The same results are available on 2 moles ethoxylated bisphenol A dimethacrylate (read-across).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From August 11 to 14, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted similarly to OECD guideline 404
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Individual animal weights not reported
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Hampshire, England
- Age at study initiation: Approximately 10-11 weeks
- Weight at study initiation: 2.3-2.6 kg
- Housing: Housed individually in metal cages
- Diet: Standard laboratory diet (SDS Stanrab (P) Rabbit diet), ad libitum
- Water: Drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30-70 %
- Air changes: Approximately 19 air changes/h
- Photoperiod: 12 h dark / 12 h artificial light
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 h
Observation period:
4 days [Day 1 (approximately 60 min after removal of the dressings) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h after exposure)]
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: Test substance was applied under a 25 mm X 25 mm gauze pad to one intact skin site on each animal.
- Type of wrap if used: Treatment site was covered with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: After 4 h of exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30-40 °C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

SCORING SYSTEM:
- Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- No dermal response to treatment was observed in any animal throughout the observation period.
Other effects:
- No signs of toxicity were observed in any animal throughout the observation period.

Table 1: Dermal reactions observed after application of Bisphenol A ethoxylated diacrylate

Rabbit number and sex (male)

E = Erythema

O = Oedema

Day

1*

2

3

4

2268

E

0

0

0

0

O

0

0

0

0

2269

E

0

0

0

0

O

0

0

0

0

2270

E

0

0

0

0

O

0

0

0

0

 

* Approximately 30 minutes after removal of the dressing

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
Executive summary:

In a primary dermal irritation study performed similarly to OECD Guideline 404 and in compliance with GLP, three New Zealand White male rabbits were dermally exposed to 0.5 mL of Bisphenol A ethoxylated diacrylate, under a semi-occlusive patch (25 mm X 25 mm) for 4 h to intact clipped skin of the dorso-lumbar region. After removal of the residual test material, animals were observed for 4 days. Irritation was scored by the method of Draize at Day 1 (approximately 60 min after removal of the dressings) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h) after exposure.

No dermal reactions and signs of toxicity to treatment were observed in any animal throughout the observation period. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were respectively 0, 0, 0 for erythema and 0, 0, 0 for oedema score. In this study, Bisphenol A ethoxylated diacrylate is not a skin irritant on male rabbits.

 

Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From August 16 to 25, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted similarly to OECD Guideline 405 with minor deviations: individual animal weights not reported
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
individual animal weights not reported
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Hampshire, England
- Age at study initiation: Approximately 10-13 weeks
- Weight at study initiation: 2.3-3.1 kg
- Housing: Housed individually in metal cages
- Diet: Standard laboratory diet (SDS Stanrab (P) Rabbit diet), ad libitum
- Water: Drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 °C
- Humidity: 30-70 %
- Air changes: Approximately 19 air changes/h
- Photoperiod: 12 h dark / 12 h artificial light
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
no washing was done
Observation period (in vivo):
7 days
- Examination of the eyes was made after 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h after instillation), 4 and 7 days after instillation.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld light.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed.
- Temporary mild conjunctival reactions only were seen.
- Eyes were normal one day after instillation.
Other effects:
- No signs of toxicity were observed in any animal throughout the observation period.

Table 1: Ocular reactions observed after instillation of Bisphenol A ethoxylated diacrylate

Rabbit

number

and sex

 

Region of eye

 

1 h

Day after instillation

1

2

3

4

7

2293 * (Female)

Cornea

 

0

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

1

0

0

0

0

0

Chemosis

 

1

0

0

0

0

0

2294 (Female)

Cornea

 

0

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

1

0

0

0

0

0

Chemosis

 

1

0

0

0

0

0

2295 (Female)

Cornea

 

0

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

1

0

0

0

0

0

Chemosis

 

1

0

0

0

0

0

* Pilot animal

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
Executive summary:

In an eye irritation study conducted similarly to the OECD Guideline 405 and in compliance with GLP, 3 healthy female rabbits of the New Zealand White strain were exposed to 0.1 mL of Bisphenol A ethoxylated diacrylate in one eye, while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h), 4 and 7 days after instillation and graded according to the method of Draize (1977). 

No corneal damage or iridial inflammation was observed. Temporary mild conjunctival reactions only were seen. All the eyes were normal one day after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score. In this study, Bisphenol A ethoxylate diacrylate is not an eye irritant on female rabbits.

Under the test conditions, Bisphenol A ethoxylated diacrylate is not classified as irritating to eyes according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation (read-across)

In the study on Bisphenol A ethoxylated diacrylate (Parcell 1993), three rabbits were dermally exposed under a semi-occlusive patch for 4h to intact clipped skin of th

e dorso-lumbar region. After removal of the residual test material, animals were observed for 4 days. Irritation was scored by the method of Draize at Day 1 (approximately 60 min after removal of the dressings) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h) after exposure.

No dermal reactions and signs of toxicity to treatment were observed in any animal throughout the observation period. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were respectively 0, 0, 0 for erythema and 0, 0, 0 for oedema score.

According to this study, Bisphenol A ethoxylated diacrylate is not a skin irritant on rabbits.

Eye irritation (read-across)

In the study on Bisphenol A ethoxylated diacrylate (Parcell 1993), eye irritation study conductedsimilarlyto the OECD Guideline 405 and in compliance with GLP, 3 healthy female rabbits of the New Zealand White strain were exposed to 0.1 mL of Bisphenol A ethoxylate diacrylate (SR 349) in one eye, while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined unwashed and the changes were observed at 1 h and 1, 2, 3 (equivalent to 24, 48 and 72 h), 4 and 7 days after instillation and graded according to the method of Draize (1977). 

No corneal damage or iridial inflammation was observed. Temporary mild conjunctival reactions only were seen. All the eyes were normal one day after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score. In this study, Bisphenol A ethoxylated diacrylate is not an eye irritant on female rabbits.


Justification for selection of skin irritation / corrosion endpoint:
A read-across is proposed for this endpoint with Ethoxylated bisphenol A diacrylate and 2 moles Ethoxylated bisphenol A dimethacrylate. The study on Ethoxylated bisphenol A diacrylate is flagged as key study because of the composition of target substance (Ethoxylated bisphenol A dimethacrylate).

Justification for selection of eye irritation endpoint:
A read-across is proposed for this endpoint with Ethoxylated bisphenol A diacrylate and 2 moles Ethoxylated bisphenol A dimethacrylate. The study on Ethoxylated bisphenol A diacrylate is flagged as key study because of the composition of target substance (Ethoxylated bisphenol A dimethacrylate).

Justification for classification or non-classification

No damage or irritation on the skin was observed in the rabbit study. Bisphenol A ethoxylated methacrylate is considered to be not irritating for skin. No classification is expected for skin irritation endpoint, according to the Regulation EC n°1272/2008 and the Directive 67/548/EEC.

No irritation was observed on eyes in the rabbit study. Bisphenol A ethoxylated methacrylate is considered to be irritating for eyes. No classification is expected for eye irritation endpoint, according to the Regulation EC n°1272/2008 and the Directive 67/548/EEC.

No study by inhalation is available to evaluate the irritant potential of Bisphenol A ethoxylated methacrylate on the respiratory tract. But, as the substance is not skin or eye irritant, no irritation on the respiratory tract is expected. No classification is proposed.