Dodecyl acrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, C12-14-alkyl esters

EC Number:

282-516-8

EC Name:

2-Propenoic acid, C12-14-alkyl esters

Cas Number:

84238-60-8

Molecular formula:

Unspecified

IUPAC Name:

2-Propenoic acid, C12-14-alkyl esters

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Remarks:

and intact skin

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL of the undiluted test substance

Duration of treatment / exposure:

24 hour(s)

Observation period:

7 days

Number of animals:

12 (6 animals were treated on intact skin)

Details on study design:

TEST PROCEDURE
- Primary irritation to the skin was measured by a patch-test technique on the abraded and intact skin of albino rabbits. Twelve healthy adult New Zealand White albino rabbits were used for the test substance.
- Pretreatment: 24 hours prior to applying the material, the hair was removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions
- Application procedure: The test substance was brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
- Abrasions: The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
- Exposure: After an exposure period of 24 hours the patches and the material applied were removed.
- Readings of skin reactions: Readings were performed after 24 and 72 hours. If, at the second reading, distinct irritation was observed a third reading was performed after seven days. After the final reading all rabbits were killed and, in the case of eschar formation, the scab was removed to examine the nature of the underlying tissue damage.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 h

Score:

2.4

Max. score:

8

Remarks on result:

other:

Remarks:

intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

1.42

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other:

Remarks:

intact skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

0.6

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other:

Remarks:

intact skin

Irritant / corrosive response data:

After 24 hours, intact skin : very slight or well-defined erythema and very slight edema .
After 24 hours, abraded skin: very slight or well-defined erythema, slight ischemia and slight edema.
After 72 hours, intact skin: very slight or well-defined erythema, slight scaliness and very slight edema.
After 72 hours, abraded skin: very slight erythema, slight scaliness and very slight edema.
On the abraded skin the test compound caused edema to a slightly higher degree than on the intact skin .
As to the other dermal effects observed there were no differences between reactions of the intact skin and those of the abraded skin .

Any other information on results incl. tables

Generally, the following dermal effects were observed:
After 24 hours, intact skin: very slight or well-defined erythema and  very slight edema.
After 72 hours, intact skin: very slight or well-defined erythema, slight  scaliness and very slight edema.
On the abraded skin the test compound caused edema to a slightly higher  degree than on the intact skin.
As to the other dermal effects observed, there were no differences  between reactions of the intact skin and those of the  abraded skin.

Individual and average skin irritation scores:

	Intact skin					Abraded skin
No. Animal	24 h		72 h		No. animal	24 h		72 h
	A	B	A	B		A	B	A	B
1	2	1	1	0		2	2	1	1
2	2	1	1	0		4	2	1	0
3	1	0	1	0		2	2	1	0
4	1	1	1	0		2	2	1	1
5	2	1	2	1		2	2	1	0
6	2	1	1	1		1	1	1	0
average	1.7	0.8	1.2	0.3		2.1	1.8	1.0	0.3
Sum	2.5		1.5			4.0		1.3

A: erythema
B: edema


Mean values over 24 and 72 hours (intact skin):

No. Rabbit	Erythema	Edema
1	1.5	0.5
2	1.5	0.5
3	1.0	0.0
4	1.0	0.5
5	2.0	1.0
6	1.5	1.0
average	1.42	0.6

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met