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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Frey-Tox, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Lot/Batch number 1112506
Specification Octenidin-Dihydrochloride
Description Almost white powder
Purity 100%

Test animals

Species:
rabbit
Strain:
other: SPF albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
Total volume applied 0.5 g was applied to a patch, moistened with water and placed on the test field
Duration of treatment / exposure:
4 h
Observation period:
Up to 49 d (1 animal)
Number of animals:
3
Details on study design:
Removal of test substance Skin was cleaned with mild soap and lukewarm water

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.4
Max. score:
3
Reversibility:
not fully reversible within: 49d
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
not fully reversible within: 49d
Remarks on result:
no indication of irritation
Other effects:
In spite of cleaning with mild soap and lukewarm water, it was not possible to remove the test substance completely from the skin and whitish spots of Octenidine dihydrochloride stayed on the skin.

Any other information on results incl. tables

 

Animal

Observation time (h)

Erythema

Edema

0

1

24

48

72

AV
24-72

0

1

24

48

72

AV
24-72

3885

1

0

2

2

2

2.4

0

0

3

2

2

2.6

3586

-

1

2

3

3

-

0

2

3

3

3587

-

2

2

3

3

-

0

2

3

3

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Octenidin-Dihydrochlorid is skin irritating under the conditions of this study and should be classified as skin irritating (R38).
Executive summary:

A skin irritation study was conducted with rabbits according to the OECD guideline No. 404. The mean values for erythema and edema formation calculated were 2.4 and 2.6, indicating that the compound is mildly to moderately irritating. The effects were not reversible within 14 days. However, the test substance could not be removed completely after the 4 hours exposure. Therefore the long persistent effect is rather due to the persistence of the test substance on the skin (due to its surface active properties), than to corrosive properties.