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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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 2% 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:
2% in petroleum
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2% in petroleum
No. of animals per dose:
25 volunteers

The substance produced no sensitization reactions

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Laevo bornyl acetate was determined to be not sensitizing to the human skin at 2% in petrolatum.
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 2% in petrolatum. The substance produced no sensitization reactions.

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

Weight of evidence: Experimental data on laevo-bornyl 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 2% in petrolatum. The substance produced no sensitization reactions.

Weight of evidence: 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 laevo bornyl acetate was determined to be not sensitizing to the skin.


Migrated from Short description of key information:
Weight of evidence: Based on experimental data on the substance laevo-bornyl acetate and on the read-across approach from the analogue isobornyl acetate, the substance was determined to be not sensitizing to the skin.

Justification for selection of skin sensitisation endpoint:
Two studies available with Klimisch score = 2.

Justification for classification or non-classification

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