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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 81

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

Molecular formula:

Unspecified

IUPAC Name:

11-methyldodecyl 2-methylprop-2-enoate

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: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, D-4932 Extertal
- Age at study initiation: 10 weeks
- Housing: individually
- Diet (e.g. ad libitum): conventional Iaboratory diet (mümmel z, ssniff/Soest), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2°C
- Humidity (%): 40 -50%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent areas of untreated skin of each animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

8 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: left flank

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test substance was removed by water.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1 h, 24, 48 and 72 hrs and at 8 d

SCORING SYSTEM:
- Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

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: 48 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 d

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks:

however, a tendency towards reversibility was noted

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 d

Any other information on results incl. tables

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	1/0/1	3/1/2
24 h	1/0/1	2/2/1
48 h	1/0/0	1/2/1
72 h	0/0/0	1/1/1
0 d	Not recorded (reversible)	0/1/0
Average 24h, 48h, 72h	0.67/0/0.33	1.67/1.67/191.4%

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, Isotridecyl Methacrylate is not a dermal irritant.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404 (1981), 3 male young adult New Zealand White rabbits were dermally exposed to 0.5 g of Isotridecyl Methacrylate (91.4%) for 4 hours.  Animals then were observed for 9 days.  Irritation was scored by the method of Draize.

Very slight erythema was observed for up to 48 h. Slight to moderate edema was observed in all three animals. Grade 1 edema was still present after 8 d. However, as a tendency toward reversibility was noted, it is judged to be reversible.

In this study, Isotridecyl Methacrylate is not a dermal irritant.

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