Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. A scientific review (peer reviewed). No data on GLP.

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
1975
Reference Type:
publication
Title:
Unnamed
Year:
1966

Materials and methods

Principles of method if other than guideline:
The maximization test was carried out on 25 volunteers; the material was tested at a concentration of 10% in petrolatum.
Test method according to Kligman, A. M. (1966). The identification of contact allergens by human assay. III. The maximization test. A procedure
for screening and rating contact sensitizers. J. invest. Derm, 47, 393.
GLP compliance:
not specified
Type of study:
other: maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
EC Number:
204-727-6
EC Name:
Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Cas Number:
125-12-2
Molecular formula:
C12H20O2
IUPAC Name:
(1S,2S,4S) 1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate
Details on test material:
- Name of test material (as cited in study report): Isobornyl acetate
- Molecular formula (if other than submission substance): C12H20O2
- Molecular weight (if other than submission substance): 196.286
- Smiles notation (if other than submission substance): CC(=O)O[C@H]1C[C@@H]2CC[C@@]1(C)C2(C)C
- InChl (if other than submission substance): 1/C12H20O2/c1-8(13)14-10-7-9-5-6-12(10,4)11(9,2)3/h9-10H,5-7H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig.

In vivo test system

Test animals

Species:
human
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
10% in petroleum
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
10% in petroleum
No. of animals per dose:
25 volunteers

Results and discussion

Any other information on results incl. tables

The substance produced no sensitization reactions

The data matrix is included in the reporting format attached.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the read-across approach from experimental data on the analogue isobornyl acetate, dextro alpha fenchyl acetate is determined to be not sensitizing to the skin.
Executive summary:

The maximization test of the analogue isobornyl acetate was carried out on 25 volunteers according to the method described by Kligman, A.M (1966). The material was tested at a concentration of 10% in petrolatum. The substance produced no sensitization reactions. Based on these results, the read-across was applied and dextro alpha fenchyl acetate was determined to be not sensitizing to the skin.