Registration Dossier

Administrative data

Description of key information

No evidence of delayed contact hypersensitivity was seen in a study according to OECD 406 after treatment with the highest possible concentrations of Octenidine dihydrochloride (intradermal induction: 0.0125%, dermal induction: 1%, dermal challenge: 0.5%).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Frey-Tox, Germany
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing in vivo study
Test material information:
Composition 1
Specific details on test material used for the study:
Lot/Batch number 1112506
Specification Octenidine-dihydrochloride
Description Almost white powder
Purity 100%
Species:
guinea pig
Strain:
other: SPF albino, stock Crl:HA
Sex:
female
Route:
other: Combined intradermal injections and closed patch topical applications
Vehicle:
other: FCA
Concentration / amount:
Intradermal: 0.0125%
Dermal: 1%
Day(s)/duration:
0
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
other:
Concentration / amount:
0.5%
Day(s)/duration:
21
Adequacy of challenge:
not specified
No. of animals per dose:
20, control: 10
Details on study design:
Induction schedule
Group 1: control animals
Day 0: 3 pairs of intradermal injections were given simultaneously into the shoulder region (clipped free of hair); each dose was 0.1 ml
1st pair: Freund’s complete adjuvant (FCA) mixed 1:1 with sterile water
2nd pair:
Group 1: water
Group 2: 0.125 % octenidine dihydrochloride in water
3rd pair:
Group 1: equal amounts of water and FCA/water in the ratio 1:1 (v/v)
Group 2: equal amounts of 0.025 % octenidine dihydrochloride in water and FCA/water in the ratio 1:1 (v/v)
Day 7: closed patched topical application of 0.25 ml vehicle (group 1) or 1% test item concentration (group 2) for 28 hours

Challenge controls:
yes
Positive control substance(s):
no
Remarks:
No concurrent positve control. Reliability of the test system inciated by positive findings with other test substances.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5%
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
slight or discrete erythema and papules
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Intradermal injections of FCA mixed with the test substance or vehicle elicited skin reactions during the dermal induction period.

The animals showed no signs of illness and had a normal body weight gain during the study.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study the test item Octenidin-Dihydrochlorid showed no dermal sensitizing potential in guinea pigs.
Executive summary:

Octenidine dihydrochloride was testedfor delayed contact hypersensitivity using the guinea pig maximation test. The test was performed according to OECD guideline No.406. The control animals showed no skin reactions. 15% of the test group animals positively responded to the treatment with octenidine dihydrochloride with slight or discrete erythema and papules 48 hours after the challenge application.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

No classification justified.