Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 May - 10 June 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in compliance with OECD Guideline 404 without any deviation.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Zinc Dimethacrylate
- Physical state: White powder
- Analytical purity: 95.3 %
- Lot/batch No.: 1107289741
- Date of receipt: 10 April 2012
- Expiration date of the lot/batch: 31 October 2012
- Storage condition of test material: Room temperature in the dark over silica gel

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.59-2.64 kg
- Housing: Animals were individually housed in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod: 12 h dark / 12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: 0.5 g of the test item, moistened sufficiently with 0.5 ml of distilled water to achieve paste consistency
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
7 days for first animal and 72 h for remaining two animals.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Dorsal/flank area
- Type of wrap if used: Test item was applied to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patch, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the 4 hour exposure period.

REMOVAL OF TEST SUBSTANCE
- After removal of the dressing, any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: According to OECD Guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
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:
- Very slight erythema and very slight oedema were noted at one treated skin site immediately after patch removal with well-defined erythema and slight oedema noted at 1 and 24 h after patch removal. Well-defined erythema and very slight oedema were noted at this treated skin site at the 48 and 72 h observations. Light brown discolouration of the epidermis and loss of skin elasticity were noted at this treated skin site at the 24, 48 and 72 h observations with slight desquamation noted at the 7-Day observation.
- No evidence of skin irritation was noted at two treated skin sites during the study.
Other effects:
All animals showed expected bodyweight gain during the study.

Any other information on results incl. tables

Table 7.3.1/1: Individual Skin Reactions

Skin Reaction

Observation Time

(following patch

removal)

Individual Scores – Rabbit Number and Sex

72042 Male

72101 Male

72102 Male

Erythema/Eschar

Formation

Immediately

1

0

0

1 h

2

0

0

24 h

2 BrLe

0

0

48 h

2 BrLe

0

0

72 h

2 BrLe

0

0

7 days

0D

-

-

Mean (24, 48 and 72 h)

2

0

0

Oedema

Formation

Immediately

1

0

0

1 h

2

0

0

24 h

2

0

0

48 h

1

0

0

72 h

1

0

0

7 days

0

-

-

Mean (24, 48 and 72 h)

1.3

0

0

Br = Light brown discolouration of the epidermis

Le = Loss of skin elasticity

D = Slight desquamation

- = Not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Zinc Dimethacrylate 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 according to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 0.5 g of Zinc Dimethacrylate under a semi-occlusive dressing. The test item was first evaluated on a single animal and the duration of exposure was 4 h on the dorsal/flank area. After consideration of the skin reactions produced in the first animal, two additional animals were similarly treated. After removal of the residual test item, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h and 7 days after exposure.

Very slight erythema and very slight oedema were noted at one treated skin site immediately after patch removal with well-defined erythema and slight oedema noted at 1 and 24 h after patch removal. Well-defined erythema and very slight oedema were noted at this treated skin site at the 48 and 72 h observations. Light brown discolouration of the epidermis and loss of skin elasticity were noted at this treated skin site at the 24, 48 and 72 h observations with slight desquamation noted at the 7-Day observation. No evidence of skin irritation was noted at two treated skin sites during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 2, 0, 0 for erythema and 1.3, 0, 0 for oedema score, respectively. In this study, Zinc Dimethacrylate is not a skin irritant on male rabbits.

Under the test conditions, Zinc Dimethacrylate 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).