Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
Species:
human
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
10% in petroleum
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
10% in petroleum
No. of animals per dose:
25 volunteers

The substance produced no sensitization reactions

The data matrix is included in the reporting format attached.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Key study: Read-across from experimental data on the analogue isobornyl acetate:

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.


Migrated from Short description of key information:
Key study: Based on the read-across approach, dextro alpha fenchyl acetate was determined to be not sensitizing to the skin.

Justification for selection of skin sensitisation endpoint:
Only one study available.

Justification for classification or non-classification

Based on the available data, the substance is not classified for skin sensitization in accordance with CLP Regulation (EC) no. 1272/2008.