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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is a screening test but followed international guidance requirements with acceptable restrictions.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: 24h exposure under occlusive patch conditions, no certificate of analysis
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
EC Number:
934-058-1
IUPAC Name:
Reaction mass of N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide and methacrylic acid
Test material form:
other: Amber liquid
Details on test material:
- Name of test material (as cited in study report): DV-2422N

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: young adults
- Weight at study initiation: 1500-2500 g
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

IN-LIFE DATES: From: To: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and unabraded areas
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL liquid) or 0.5g (solid)
- Concentration (if solution): not applicable as the test substance is applied as supplied

VEHICLE
Not applicable
Duration of treatment / exposure:
24h
Observation period:
48h after the patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: abdomen
- % coverage: one inch square, two application sites on the right side (abraded skin) and two application sites on the lef side (unabraded skin)
- Type of wrap if used: the test sample is applied on a coton gauze which is held in place with adhesive tape. The entire trunk of the animal is then wrapped wih a rubberized cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
unabraded skin
Basis:
animal #1
Time point:
other: mean 24/72h after the start of the exposure
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other:
Remarks:
observations were made at 24h and 72h after the start of exposure
Irritation parameter:
erythema score
Remarks:
unabraded skin
Basis:
animal #2
Time point:
other: mean 24/72h after the start of the exposure
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other:
Remarks:
observations were made at 24h and 72h after the start of exposure
Irritation parameter:
erythema score
Remarks:
unabraded
Basis:
animal #3
Time point:
other: mean 24/72h after the start of the exposure
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other:
Remarks:
observations were made at 24h and 72h after the start of exposure
Irritation parameter:
edema score
Remarks:
unabraded skin
Basis:
animal #1
Time point:
other: mean 24/72h after the start of the exposure
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other:
Remarks:
observations were made at 24h and 72h after the start of exposure
Irritation parameter:
edema score
Remarks:
unabraded skin
Basis:
animal #2
Time point:
other: mean 24/72h after the start of the exposure
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other:
Remarks:
observations were made at 24h and 72h after the start of exposure
Irritation parameter:
edema score
Remarks:
unabraded skin
Basis:
animal #3
Time point:
other: mean 24/72h after the start of the exposure
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other:
Remarks:
observations were made at 24h and 72h after the start of exposure
Irritant / corrosive response data:
See details in Tables 7.3.1/1 and 7.3.1/2
Other effects:
no data

Any other information on results incl. tables

Table 7.3.1/1:Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on unabraded skin

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

24 h

1/2/2

1/2/2

72 h

0/0/0

0/0/0

Average 24h and 72h

0.5/1.0/1.0

0.5/1.0/1.0

Reversibility

Yes

Yes

 

Table 7.3.1/2:Irritant/corrosive response data for each animal at each observation time after the topical application of the test substance on abraded skin

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

24 h

1/2/2

1/2/2

72 h

1/1/1

0/0/0

Average 24h and 72h

1/1.5/1.5

0.5/1.0/1.0

Reversibility

No data

Yes

 

The primary dermal irritation index (PDII) was 1.92.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test item Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified as skin irritant when applied topically to rabbits according to the criteria of the CLP regulation (EC) 1272/2008 and to the criteria of the Directive 67/548/EEC.
Executive summary:

In a dermal irritation study performed similarly to the OECD guideline No. 404, 3 New Zeland Albino rabbits, were dermally exposed to 0.5 mL of undiluted Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide.

Prior to the topical application, the skin of the rabbit was prepared with a clipper to remove the hair. After clipping, the right side of the animal was prepared by making epidermal abrasions, while the left site remained intact (clipped but unabraded). The test substance was then applied on the skin (abraded or not) on two different application sites (4 application sites in total on each animal). Then the test sites were covered with an occlusive dressing for 24 hours. Those exposure conditions correspond to a worst case approach as the test guidance recommends an exposure under semi-occlusive patch and for4h.Skin irritation was assessed and scored according to the Draize scale at 24 and 72 hrs after the topical application of the test patch.  

The mean individual scores calculated within 2 scoring times (24 and 72 hrs) for the unabraded skin were 0.5/1.0/1.0 for erythema and 0.5/1.0/1.0 for edema.

Under the test conditions, the test item Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified as skin irritant when applied topically to rabbits according to the criteria of the CLP regulation (EC) 1272/2008 and to the criteria of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.