Dodecyl methacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20.06.1989-28.06.1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD 404, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 21 May 1981. EEC Directive 84/449/EEC, Part B: methods for the determination of Toxicity, B5. Acute Toxicity. Skin irritation. Official Journal of the European Communities, No L251, pp. 106-108

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

EC Number:

288-509-6

EC Name:

2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

Cas Number:

85736-97-6

IUPAC Name:

2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were housed individually. Conventional laboratory diet (mümmel z, ssniff / Soest) and an unrestricted supply of drinking water
were available. The temperature of the experimental animal room was 18 °C (±2 °C) and the relative humidity 40 to 50 %.
Lighting sequence: 12 hrs light, 12 hrs darkness
Condition time: 7 days

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g, undiluted

Duration of treatment / exposure:

4 hours
At the end of the exposure period, residual test substance was removed by water.

Observation period:

After patch removal the skin was examined at 1 h, then at 24, 48 and 72 hrs and at day 8.

Number of animals:

3, 10 weeks old

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data availible
- Type of wrap if used: non-irritating tape, semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by water

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.

Remarks:

mean 24 + 48 + 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.

Remarks:

mean 24 + 48 + 72 h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.

Remarks:

mean 24 + 48 + 72 h

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.

Remarks:

mean 24 + 48 + 72 h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 4 h semiocclusive exposure, reevaluated according CLP-criteria.

Remarks:

mean 24 + 48 + 72 h

Other effects:

No evidence of systemic effects.

Any other information on results incl. tables

	Erythema				Edema
	24h	48h	72h	9d	24h	48h	72h	8d
Animal 1	1	1	0	0	2	1	1	0
Animal 2	0	0	0	0	2	2	1	1
Animal 3	1	1	0	0	1	1	1	0
Mean	0.66666667	0.66666667	0	0	1.66666667	1.33333333	1	0.33333333
Total-mean	0.44444444				1.33333333
	Erythema				Edema

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not irritating: Criteria used for interpretation of results: OECD GHS

Conclusions:

Isotridecyl methacrylate has some mild irritating potential to skin.
However, it is non-irritating with respect to EU and UN-GHS classification criteria.

Executive summary:

In a primary dermal irritation study (OECD 404, GLP) 3 New Zealand White rabbits were dermally exposed for 4 hours with 0.5 g undiluted Isotridecyl methacrylate under semiocclusiv conditions. Animals were observed after 1h, 24h, 48h 72h and after 8 or 9 days. The test was reevaluated acc. CLP criteria. Mean erythema scores after 24, 48 and 72 hours were 0, 0.33 and 0.66 of max. 4. Mean edema scores 0, 1.33 and 1.66 of max. 4. All reactions were fully reversible after 72 h or 8 days. Under CLP criteria Isotridecyl methacrylate is not irritating to skin.

The results demonstrate that Isotridecyl methacrylate (CAS 85736-97-6) is not a dermal irritant.

Therefore the test substance has to be classified - according to EU and GHS classification criteria - as non irritant for skin (GHS-hazard category: none).

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