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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Bewertung der allergologishen Eigenshaften von cetyl- und stearylalkohol (Review of allergological properties of cetyl and stearyl alcohol)
- Author:
- Gloxhuber, Ch.
- Year:
- 1 983
- Bibliographic source:
- Arztliche Kosmetologie 13:181-186 (Physician's cosmetology 13: 181-186)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Magnusson and Kligman guinea pig maximization procedure.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Method: other: Magnusson and Kligman guinea pig maximization procedure.
Test material
- Reference substance name:
- Alcohols, C16-18
- EC Number:
- 267-008-6
- EC Name:
- Alcohols, C16-18
- Cas Number:
- 67762-27-0
- Molecular formula:
- C16 H34 O
- IUPAC Name:
- Alcohols, C16-18
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report):trade product containing C16/C18 alcohols.
- Several preparations were tested, hexadecanol, octadecanol, a mixture of C12/1C8 coco-alcohols, a mixture of C16/C18 tallow alcohols and Lanette 0, a trade product containing C16/C18 alcohols.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: guinea pig
- Sex: female
- Weight at study initiation: 400-500 g
- Number of animals: 20
- Controls: 20
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 44-74
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1st induction olive oil; 2nd induction vaseline; challenge vaseline or ethanol.
- Concentration / amount:
- 1st: Induction 5 % intracutaneous
2nd: Induction 5 % occlusive epicutaneous
3rd: Challenge 25 % open epicutaneous
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1st induction olive oil; 2nd induction vaseline; challenge vaseline or ethanol.
- Concentration / amount:
- 1st: Induction 5 % intracutaneous
2nd: Induction 5 % occlusive epicutaneous
3rd: Challenge 25 % open epicutaneous
- No. of animals per dose:
- 40
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Study type: M&K maximization
- Preparation of test substance for induction: 5% intracutaneous in olive oil.
- Preparation of test substance for induction: 5% topical in vaseline.
- Concentrations used for induction: 25% topical in vaseline
- Concentration in Freuds Complete Adjuvant (FCA): 1:1
- Positive control: Not reported - Challenge controls:
- 10 non-induced animals received challenge applications.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 29
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 and 25% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 and 25% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
Any other information on results incl. tables
RESULTS OF TEST
- Sensitization reaction: Response 0/20 test, 0/20 control
- Clinical signs: None
- Rechallenge: Not required
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In a reliable study, Alcohols, C16-18 was not a skin sensitiser in guinea pigs.
- Executive summary:
Alcohols, C16-18 is not a skin sensitiser in the guinea pig when tested using the Magnusson and Kligman maximisation assay.
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.
