N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Frey-Tox, Germany

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride

EC Number:

274-861-8

EC Name:

N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride

Cas Number:

70775-75-6

Molecular formula:

C36H62N4 · 2 HCl

IUPAC Name:

1,1´-Decamethylen-bis[1,4-dihydro-4-(octylimino)pyridine]-dihydrochloride

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

Results

Results 1

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

Results 2

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.