Registration Dossier

Administrative data

Description of key information

Octenidine dihydrochloride as powdery test item moistened with water was skin irritating in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Frey-Tox, Germany
Test material information:
Composition 1
Specific details on test material used for the study:
Lot/Batch number 1112506
Specification Octenidin-Dihydrochloride
Description Almost white powder
Purity 100%
Species:
rabbit
Strain:
other: SPF albino
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
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.

 

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

 

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Justification for type of information:
No eye irritation study of the undiluted test substance is available. As octenidine dihydrochloride is strongly irritating in studies on dermal irritation, for animal welfare reasons, no study should be performed, and it should be assumed that octenidine dihydrochloride is corrosive to the eyes.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No eye irritation study of the undiluted test substance is available. As octenidine dihydrochloride is strongly irritating in studies on dermal irritation, for animal welfare reasons, no study should be performed, and it should be assumed that octenidine dihydrochloride is corrosive to the eyes.

Justification for classification or non-classification

Based on the available results, octenidine diyhrochloride is classified with R36, irritating to the eyes and should in addition be classified with R38 irritating to skin.