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

Endpoint summary

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Frey-Tox, Germany

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.