Sodium undec-10-enoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21/03/2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium undec-10-enoate

EC Number:

222-264-8

EC Name:

Sodium undec-10-enoate

Cas Number:

3398-33-2

Molecular formula:

C11H20O2.Na

IUPAC Name:

sodium undec-10-enoate

Specific details on test material used for the study:

sodium undec-10-enoate in a 33.2% aqueous solution

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A single dose of 0.5ml of the test substance in its original form was prepared on a gauze patch and then applied to a 6cm2 clipped area of 3 male New Zealand rabbits.

Duration of treatment / exposure:

4 hours

Observation period:

1 hour, 24 hours, 48 hours, 72 hours

Number of animals:

3

Details on study design:

First of all, the test was performed using one animal in order to check that the result by cutaneous route was non-existant to moderate. The test was contined using 2 other animals 72 hours after the cutaneous application in the first animal. The test substance was held in contact with the skin for 4 hours by means of a semi-occlusive dressing. The cutaneous reactions were observed 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily in order to observe their reversibility or irrersibility.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible within:

Remarks:

six days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible within:

Remarks:

eleven dadys

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 2

Reversibility:

fully reversible within:

Remarks:

eleven days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The substance is consiedered as irritant by cutaneous route in the rabbit.

Executive summary:

The skin irritation study was performed according to the OECD 404 guideline. -

0.5ml of the substance sodium undec-10-enoate (in a 33.2% aqueous solution) was applied under a semi-occlusive patch to rabbits for 4 hours.

The substance is considered as irritant by cutaneous route in the rabbit.