2-Propenoic acid, 2-methyl-, C12-15-branched and linear alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study 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)

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:

85736-97-6

Constituent 2

Reference substance name:

Isotridecyl methacrylate

EC Number:

304-180-4

EC Name:

Isotridecyl methacrylate

Cas Number:

94247-05-9

Molecular formula:

C17H32O2

IUPAC Name:

Isotridecyl methacrylate

Details on test material:

- Supplier: Evonik Röhm GmbH, D-64293 Darmstadt, Germany
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data

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

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

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:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1 - 72 h

Score:

1.67

Max. score:

8

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0.44

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

1.33

Max. score:

4

Remarks on result:

other: In 1 animal not fully reversible within 8 days

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:

not irritating

Remarks:

Migrated information 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 an acute dermal irritation / corrosion study (OECD 404, GLP) New Zealand White rabbits (strain: no data) were dermally exposed to undiluted 0.5 g Isotridecyl methacrylate for 4 hours. Animals then were observed for 8 or 9 days.

The mean erythema score (average value of the single scores (animals 1-3; erythema; intact skin, 24h, 48 h and 72h)  was determined to be 0.44 out of 4 and, accordingly, the mean edema score 1.33 out of 4. 

 

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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