Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.