Registration Dossier
Registration Dossier
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EC number: 205-597-3 | CAS number: 143-28-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Méthodes officielles d'Analyse des cosmétiques et produits de beauté. Journal Officiel de la République Française du 21/4/71, édition Lois et Décrets, et du 5/6/73, ed.
- Deviations:
- yes
- Remarks:
- (Treatment time reduced from 3 months to 8 weeks. Daily readings expressed as weekly average)
- GLP compliance:
- not specified
- Type of study:
- other: repeated skin application
Test material
- Reference substance name:
- (Z)-octadec-9-enol
- EC Number:
- 205-597-3
- EC Name:
- (Z)-octadec-9-enol
- Cas Number:
- 143-28-2
- Molecular formula:
- C18H36O
- IUPAC Name:
- (9Z)-octadec-9-en-1-ol
Constituent 1
In vivo test system
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: epicutaneous [no further details]
- Vehicle:
- other: Test material was suspended in polyoxyethylene sorbitan stearate (3%), preservative (0.2%) and water (to 100%)
- Concentration / amount:
- 100%, 10%
Challengeopen allclose all
- Route:
- other: epicutaneous [no further details]
- Vehicle:
- other: Test material was suspended in polyoxyethylene sorbitan stearate (3%), preservative (0.2%) and water (to 100%)
- Concentration / amount:
- 100%, 10%
- No. of animals per dose:
- no data
- Details on study design:
- Oleyl alcohol (4 samples) was applied undiluted and as a 10% aqueous dispersion to the skin of rabbits for 60 days. At the end of this period, a challenge application was made after a 7 day rest period.
- Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Results
- Reading:
- other: no data
- Group:
- test chemical
- Dose level:
- 10% and 100%
- Clinical observations:
- no data other than 100% was badly tolerated and 10% was relatively well tolerated
- Remarks on result:
- other: Reading: other: no data. Group: test group. Dose level: 10% and 100%. Clinical observations: no data other than 100% was badly tolerated and 10% was relatively well tolerated.
Any other information on results incl. tables
No evidence of allergic reaction was reportedly observed [no further details].
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a limited study, no evidence of skin sensitization was observed in rabbits.
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