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Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
EC Number:
701-440-2
Molecular formula:
(C3H6O)x (C3H6O)y C11H16O4
IUPAC Name:
Esterification products of acrylic acid with reaction products of 2,2-dimethylpropane-1,3-diol and methyloxirane
Test material form:
liquid

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.