Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 274-861-8 | CAS number: 70775-75-6
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- 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
Test material
- 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
Constituent 1
- Specific details on test material used for the study:
- Lot/Batch number 1112506
Specification Octenidine-dihydrochloride
Description Almost white powder
Purity 100%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF albino, stock Crl:HA
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- 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
Challenge
- 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.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
