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Description of key information

Two reliable studies (Blanchard 2002, Parcell 1994) are available to evaluate the skin irritation potential, and two reliable studies (Parcell 1994, Blanchard 2002) to evaluate the eye irritation potential of Propoxylated neopentylglycol diacrylate. The substance is not irritating for skin, eyes or respiratory tract.

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
Study period:
From March 4 to 17, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no certificate of analysis of the test substance; individual animal weights not reported
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Highgate Farm, Market Rasen, England
- Age at study initiation: Approximately 9 weeks
- Weight at study initiation: 2.6-2.9 kg
- Housing: Housed individually in stainless steel cages
- Diet: Standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet), ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 ± 2 °C
- Humidity: 30-70 %
- 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:
14 days
- Day 1 (approximately 60 min after removal of the dressings) and Days 2, 3 and 4 (equivalent to approximately 24, 48 and 72 h after exposure).
- Additional observations were made for two animals on Day 5 and for one animal on Days 6 through 14.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Dorso-lumbar region
- % coverage: Test substance was applied under a 2-ply 25 mm X 25 mm porous 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 (36 °C) 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:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 11 days
Irritant / corrosive response data:
- Very slight to well defined erythema with very slight to slight oedema was seen in all animals from Day 2.
- In addition, desquamation (characterised by dryness), thickening of the skin and small scabs on dose site was observed in one rabbit from Day 5.
- Reactions had resolved completely in two animals by either Day 3 or 5, however, very slight erythema was still present in the remaining animal at study termination on Day 14.
Other effects:
- No signs of toxicity were observed in any animal throughout the observation period.

Table 1: Dermal reactions

 

Rabbit no.

& sex

E = Erythema

 

O = Oedema

Day

1*

2

3

4

5

6

7

8

9

10

11

12

13

14

3790 Male

E

0

1

0

0

-

-

-

-

-

-

-

-

-

-

O

0

1

0

0

-

-

-

-

-

-

-

-

-

-

3791 Male

E

0

2

1

1

0

-

-

-

-

-

-

-

-

-

O

0

1

0

0

0

-

-

-

-

-

-

-

-

-

3792 Male

E

0

1

1

2

2a

2a

2a

2a

2a

1a

1a

1a

1a

1a

O

0

1

0

0

1

2b

2b

2b

2bc

1bc

0

0

0

0

 

* Approximately 60 min after removal of the dressing

- Not applicable

a Desquamation (characterised by dryness)

b Thickening of the skin

c Small scabs on dose site

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

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand White male rabbits were dermally exposed to 0.5 mL of Propoxylated neopentylglycol diacrylate, under a semi-occlusive patch (25 mm X 25 mm) for 4 h to intact skin of the dorso-lumbar region. Animals were then observed for 14 days. Irritation was scored by the method of Draize at Day 1 (approximately 60 min after removal of the dressing) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h) after exposure. Additional observations were made for two animals on Day 5 and for one animal on Days 6 through 14.

Very slight to well defined erythema with very slight to slight oedema was seen in all animals from Day 2. In addition, desquamation (characterised by dryness), thickening of the skin and small scabs on dose site was observed in one rabbit from Day 5. Reactions had resolved completely in two animals by either Day 3 or 5, however, very slight erythema was still present in the remaining animal at study termination on Day 14. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were respectively 0.3, 1.3, 1.3 for erythema and 0.3, 0.3, 0.3 for oedema score. In this study, Propoxylated neopentylglycol diacrylate is not a skin irritant on male rabbits.

Under the test conditions, Propoxylated neopentylglycol diacrylate is not  irritating to skin.

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
Study period:
From January 24 to May 30, 1994
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; 6 animals tested instead of 3
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., Petersfield, England
- Age at study initiation: Approximately 12-13 weeks
- Weight at study initiation: 2.8-3.0 kg
- Housing: Housed individually in plastic 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:
6 (1 male and 5 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:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.45
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Mean individual scores = 0,67 - 0 - 1 - 0 - 0 - 1
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Mean individual scores = 0 - 0.33 - 0 - 0 - 0 - 0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.34
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Mean individual scores = 1,67 - 1,33 - 2 - 0,67 - 0,66 - 1,67
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.11
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Mean individual scores = 1 - 2 - 2 - 0,33- 0,33-1
Irritant / corrosive response data:
- Corneal opacities developed in 3 animals.
- Dulling of the normal lustre of the cornea alone was seen in 2 animals.
- Transient iridial inflammation was observed in 1 animal.
- A diffuse crimson red colouration of the conjunctivae was seen in all 6 animals and was accompanied in 4 by considerable swelling with partial eversion of the eyelids or with the eyelids about half closed.
- Eyes were normal by 3 or 7 days 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 9003

Rabbit

number

and sex

 

Region of eye

 

1 h

Day after instillation

1

2

3

4

7

020 * (male)

Cornea

 

0

0

1

1

1

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

2

2

1

1

0

Chemosis

 

1

1

1

1

0

0

070 (Female)

Cornea

 

D

0

0

0

0

0

Iris

 

0

0

0

1

0

0

Conjunctiva

 

Redness

 

2

1

1

2

2

0

Chemosis

 

2

2

2

2

1

0

071 (Female)

Cornea

 

D

1

1

1

1

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

2

2

2

2

0

Chemosis

 

2

2

2

2

1

0

553 (Female)

Cornea

 

D

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

1

1

0

0

0

Chemosis

 

2

1

0

0

0

0

554 (Female)

Cornea

 

D

0

0

0

0

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

1

1

0

0

0

Chemosis

 

3

1

0

0

0

0

555 (Female)

Cornea

 

D

1

1

1

1

0

Iris

 

0

0

0

0

0

0

Conjunctiva

 

Redness

 

2

2

2

1

1

0

Chemosis

 

1

1

1

1

0

0

 

* Pilot animal

D - Dulling

Interpretation of results:
GHS criteria not met
Remarks:
not eye irritating.
Conclusions:
Under the test conditions, Propoxylated neopentylglycol 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, 6 healthy rabbits (1 male and 5 females) of the New Zealand White strain were exposed to 0.1 mL of Propoxylated neopentylglycol 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). 

Corneal opacification, iridial inflammation and well-defined conjunctival reactions were observed. All reactions had resolved in 3 or 7 days after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 6 animals were respectively 0.67, 0.00, 1.00, 0.00, 0.00, 1.00 for cornea score; 0.00, 0.33, 0.00, 0.00, 0.00, 0.00 for iris score; 1.67, 1.33, 2.00, 0.67, 0.67, 1.67 for conjunctivae score and 1.00, 2.00, 2.00, 0.33, 0.33, 1.00 for chemosis score. In this study, Propoxylated neopentylglycol diacrylate is not an eye irritant on rabbits.

Under the test conditions, Propoxylated neopentylglycol 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 adverse effect observed (not irritating)

Additional information

Skin irritation


In the first study (Blanchard 2002), a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP. Three New Zealand White male rabbits were dermally exposed to 0.5 mL of Propoxylated neopentylglycol diacrylate, under a semi-occlusive patch (25 mm X 25 mm) for 4 h to intact skin of the dorso-lumbar region. Animals were then observed for 14 days. Irritation was scored by the method of Draize at Day 1 (approximately 60 min after removal of the dressing) and Days 2, 3 and 4 (equivalent to 24, 48 and 72 h) after exposure.Additional observations were made for two animals on Day 5 and for one animal on Days 6 through 14.


Very slight to well defined erythema with very slight to slight oedema was seen in all animals from Day 2. In addition, desquamation (characterised by dryness), thickening of the skin and small scabs on dose site was observed in one rabbit from Day 5. Reactions had resolved completely in two animals by either Day 3 or 5, however, very slight erythema was still present in the remaining animal at study termination on Day 14.Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were respectively 0.3, 1.3, 1.3 for erythema and 0.3, 0.3, 0.3 for oedema score.


In this study, Propoxylated neopentylglycol diacrylate is not a skin irritant on male rabbits.


 


In the second 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 Propoxylated neopentylglycol diacrylate, under a semi-occlusive patch (25 mm X 25 mm) for 4 h to intact skin of the dorso-lumbar region. Animals were then observed for 4 days. Irritation was scored by the method of Draize at Day 1 (approximately 60 min after removal of the dressing) 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, Propoxylated neopentylglycol diacrylate is not a skin irritant on male rabbits.


 


 


Eye irritation 


In the first study (Parcell 1994), an eye irritation study was conducted similarly to the OECD Guideline 405 and in compliance with GLP. Six healthy rabbits (1 male and 5 females) of the New Zealand White strain were exposed to 0.1 mL of Propoxylated neopentylglycol diacrylate (SR 9003) 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). 


Corneal opacification, iridial inflammation and well-defined conjunctival reactions were observed. All reactions had resolved in 3 or 7 days after instillation.Mean individual scores at 24, 48 and 72 h after exposure for the 6 animals were respectively 0.67, 0.00, 1.00, 0.00, 0.00, 1.00 for cornea score; 0.00, 0.33, 0.00, 0.00, 0.00, 0.00 for iris score; 1.67, 1.33, 2.00, 0.67, 0.67, 1.67 for conjunctivae score and 1.00, 2.00, 2.00, 0.33, 0.33, 1.00 for chemosis score. In this study, Propoxylated neopentylglycol diacrylate is not an eye irritant on rabbits.


 


In the second study (Blanchard 2002) conducted according 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 Propoxylated neopentylglycol 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 and 3 days [equivalent to approximately 24, 48 and 72 h (pilot animal) or 25, 49 and 73 h (main study animals)] after instillation and graded according to the method of Draize (1977). 


No corneal damage or iridial inflammation was observed. Transient hyperaemia of the blood vessels of the conjunctivae to a diffuse crimson colour with or without above normal swelling and above normal discharge was seen in all animals from approximately 1 h after instillation. Reactions had resolved completely by 1 or 2 days after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were respectively 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0.33, 0.33 for conjunctivae score and 0, 0.33, 0 for chemosis score.


In this study, Propoxylated neopentylglycol diacrylate is not an eye irritant on female rabbits.


 


In the in vitro test (Kreutz 2001), the irritation potential of the test substances was evaluated on the chorionallantoic membrane (CAM) of fertilized chicken eggs in order to estimate the local irritation property of the substances after contact with mucous membranes or eyes. Transparent test substances are tested by the reaction-time method. The reaction-time period and reaction intensity of effects on the CAM like haemorrhage, lysis of the vessels and protein coagulation (intravascular and/or extravasular) were visually evaluated. The substances was tested undiluted by adding approx. 300 µl to 6 eggs at least with well developed blood vessels. The amount of the added test substances covered 25% of the CAM.


The both test substances showed the lowest effects, and are predicted to be slightly irritating.


After the comparaison of the in vitro and in vivo results and based on our experience we can suppose that the both undiluted substances does not cause irritations after the contact with the mucous membrane, particularly with the eye.


 

Justification for classification or non-classification

Based on the available data, no classification for irritation is required for Propoxylated neopentylglycol diacrylate according to the Regulation EC n°1272/2008.