Registration Dossier

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:
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
Name:
Unnamed
Type:
Constituent

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 group
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.