Registration Dossier

Administrative data

Description of key information

Two reliable studies (Parcell 1993, Liggett 1992) are available to evaluate the skin irritation potential, and two reliable studies ((Parcell 1993, Vaeth 2001) to evaluate the eye irritation potential of Bisphenol A ethoxylate diacrylate . The substance is not irritating for skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 11 to 14, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
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 SR 349

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:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance is not classified as irritating to skin.
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 the test substance, 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, the test substance is not a skin irritant on male rabbits.

 

Under the test conditions, the test substance is not classified as irritating to skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 11 to 14, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
individual animal weights not reported
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 12-14 weeks
- Weight at study initiation: 2.8-3.1 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
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 30 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 (2 males and 1 female)
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 acetone to remove any residual test substance.

SCORING SYSTEM:
- Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
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 EB 150

Rabbit number and sex

E = Erythema

O = Oedema

Day

1*

2

3

4

561(male)

E

0

0

0

0

O

0

0

0

0

562 (male)

E

0

0

0

0

O

0

0

0

0

563 (female)

E

0

0

0

0

O

0

0

0

0

 

* Approximately 30 min after removal of the dressing

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test item is not irritating to skin.
Executive summary:

In a primary dermal irritation study performed similarly to OECD Guideline 404 and in compliance with GLP, three New Zealand White rabbits (2 males and 1 female) were dermally exposed to 0.5 mL of test item, 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 30 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, the test item is not a skin irritant on male and female rabbits.

 

Under the test conditions, the test item is not irritating to skin.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From December 12 to 16, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no certificate of analysis of the test substance; systemic adverse effects not followed
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Species:
rabbit
Strain:
other: SPF albino rabbits of the stock Chbb:HM (SPF) - Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, Biberach, Germany
- Weight: 2.8-2.9 kg
- Housing: Housed individually in PPO cages
- Diet: Pelleted complete rabbit diet "Altromin 2123", ad libitum
- Water: Domestic quality drinking water (acidified with hydrochloric acid to pH 2.5), ad libitum
- Acclimation period: Approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 20 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: 10 times/h
- Photoperiod: 12 h dark / 12 h light
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: After the first 24 h reading fluorescein was instilled and eyes were examined for ocular lesions. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV -light to detect possible corneal damage.

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Eyes of the animals were examined with a hand held inspection lamp fitted with white and UV -light and magnifying glass with 2 X magnifications. The examination was performed before and after instillation of fluorescein.

Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 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:
24/48/72 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
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
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 h
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:
One hour after application of the test article, animals showed conjunctival redness, chemosis and discharge different from normal. All the eyes were normal one day after instillation.
Other effects:
No

- The study was initiated with one rabbit (animal no. 1889). Since no marked eye irritation was seen in this animal another two rabbits were included in the study with time difference.

Table 1: Scores for ocular lesions

 

Rabbit No./

Weight per kg

 

1 h

 

24 h

 

48 h

72 h

Individual mean score*

 

 

 

F

1889 / 2.9

Cornea opacity, degree

 

0

0

0

0

0

0.00

Cornea opacity, area

 

0

0

0

0

0

 

Iris

 

0

0

 

0

0

0.00

Conjunctiva

 

Redness

 

1

0

 

0

0

0.00

Chemosis

 

0

0

 

0

0

0.00

Discharge

 

0

0

 

0

0

 

1895 / 2.8

Cornea opacity, degree

 

0

0

0

0

0

0.00

Cornea opacity, area

 

0

0

0

0

0

 

Iris

 

0

0

 

0

0

0.00

Conjunctiva

 

Redness

 

1

0

 

0

0

0.00

Chemosis

 

1

0

 

0

0

0.00

Discharge

 

0

0

 

0

0

 

1896 / 2.8

Cornea opacity, degree

 

0

0

0

0

0

0.00

Cornea opacity, area

 

0

0

0

0

0

 

Iris

 

0

0

 

0

0

0.00

Conjunctiva

 

Redness

 

1

0

 

0

0

0.00

Chemosis

 

1

0

 

0

0

0.00

Discharge

 

1

0

 

0

0

 

 

F - Reading after instillation of fluorescein

 

* Only the scores from the readings after 24, 48 and 72 h are included in the calculation of the individual mean scores

 

 

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, Bisphenol A ethoxylate diacrylate is not classified as irritating to eyes.
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy female albino rabbits of the stock Chbb:HM (SPF) – Littlerussian were exposed to 0.1 mL of Bisphenol A ethoxylate 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 1 h and 24 h after instillation. After the first 24 h reading fluorescein was instilled and eyes were examined for ocular lesions. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV -light to detect possible corneal damage. The eyes were also examined 48 and 72 h after the treatment. Draize (1977) scoring system was followed to grade the ocular reactions. 

One hour after application of the test article, animals showed conjunctival redness, chemosis and discharge different from normal. 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 ethoxylate diacrylate is not classified as irritating to eyes.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 16 to 25, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline 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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 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:
24/48/72 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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 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:
24/48/72 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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 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 SR 349

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:
GHS criteria not met
Conclusions:
Under the test conditions, Bisphenol A ethoxylate diacrylate is not classified as irritating to eyes.
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 ethoxylate 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 ethoxylate diacrylate is not classified as irritating to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Two reliable studies are available to evaluate the skin irritation potential of Bisphenol A ethoxylated diacrylate (Parcell 1993, Liggett 1992).

In both studies, a primary dermal irritation study was performed similarly to OECD Guideline 404 and in compliance with GLP. Three New Zealand White rabbits were dermally exposed to 0.5 mL of Bisphenol A ethoxylate 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 these both studies, Bisphenol A ethoxylated diacrylate is not a skin irritant on rabbits.

Eye irritation

Two reliable studies are available to evaluate the eye irritation potential of Bisphenol A ethoxylated diacrylate (Parcell 1993, Vaeth 2001).

In the first study (Vaeth 2001), eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP. Three healthy female albino rabbits of the stock Chbb:HM (SPF) – Littlerussian were exposed to 0.1 mL of Bisphenol A ethoxylate 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 1 h and 24 h after instillation.After the first 24 h reading fluorescein was instilled and eyes were examined for ocular lesions. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV -light to detect possible corneal damage. Theeyes were also examined 48 and 72 h after the treatment. Draize (1977) scoring system was followed to grade the ocular reactions. 

One hour after application of the test article, animals showed conjunctival redness, chemosis and discharge different from normal.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.

In the second study (Parcell 1993), 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 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 classification or non-classification

No damage or irritation on the skin was observed in the rabbit study, Bisphenol A ethoxylated diacrylate is not irritating for skin. No classification is expected for skin irritation endpoint, according to the Regulation EC n°1272/2008.

Very small irritation was observed on eyes in the rabbit study, Bisphenol A ethoxylated diacrylate is not considered to be irritating for eyes. No classification is expected for eye irritation endpoint, according to the Regulation EC n°1272/2008.

No study by inhalation is available to evaluate the irritant potential of Bisphenol A ethoxylated diacrylate 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.