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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:
1977
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

Constituent 1
Chemical structure
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

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.