Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
skin sensitisation
Data waiving:
other justification
Justification for data waiving:
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

A skin sensitisation test for this substance is waived as the constituent d-limonene (CAS 5989-27-5), present at a typical concentration of 43%, is classified as H317 (Skin Sens. 1). Based on the classification of this major constituent, Bergamot oil is considered to be classified as H317 (Skin Sens. 1) as well and therefore further testing is deemed unnecessary.

Migrated from Short description of key information:
Read-across based on classification of main constituent: sensitising

Justification for selection of skin sensitisation endpoint:
Read across based on classification of main constituent

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the skin sensitising properties of the major constituents, Bergamot oil should be classified for skin sensitisation (Skin Sens. 1/H317) in accordance with the criteria as outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).