Registration Dossier
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EC number: 274-861-8 | CAS number: 70775-75-6
Endpoint summary
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
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Frey-Tox, Germany
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing in vivo study
- 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 chemical
- 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 chemical
- 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
No classification justified.
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