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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Read across based on classification of constituents:
- Skin irritation: irritating
- Eye irritation: irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A skin irritation test for this substance is waived as the constituents d-limonene (CAS 5989-27-5), linalyl acetate (CAS 115-95-7), linalool (CAS 78-70-6), beta-pinene (CAS 127-91-3) and gamma-terpinene (CAS 99-85-4), are classified as H315 (Skin Irrit. 2). Based on the fact that these classified constituents represent 92% of the composition of Bergamot oil, this substance is considered to be classified as H315 (Skin Irrit. 2) as well and therefore further testing is deemed unnecessary.

 

Eye irritation

An eye irritation test for this substance is waived as the major constituents linalyl acetate (CAS 115-95-7) and linalool (CAS 78-70-6), present at typical concentrations of 27% and 12% respectively, are classified as H319 (Eye Irrit. 2). Based on the fact that these classified constituents represent at least 39% of the composition of Bergamot oil, this substance is considered to be classified as H319 (Eye Irrit. 2) as well and therefore further testing is deemed unnecessary.


Justification for selection of skin irritation / corrosion endpoint:
Read across based on classification of constituents

Justification for selection of eye irritation endpoint:
Read across based on classification of main constituents

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the skin irritating properties of its constituents, Bergamot oil should be classified for Skin Irritation (Skin. Irrit. 2 / H315) in accordance with the criteria as outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).

 

Based on the eye irritating properties of the major constituents, Bergamot oil should be classified for Eye Irritation (Eye Irrit. 2 / H319) in accordance with the criteria as outlined in Annex I of 1272/2008/EC (CLP/EU-GHS).