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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
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.