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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2013) was used to determine the skin sensitising potential of Pinus pinaster oil.

Some ingredients of Pinus pinaster oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, delta 3 carene, Germacrene delta) and are all present above the generic concentration limit of 1%. Therefore Pinus pinaster oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 and the Directive 1999/45/EEC.

Source: ECHA disseminated dossiers

- Pinene alpha:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html

- Pinene beta:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d85bc06-0d47-6e67-e044-00144f67d249/DISS-9d85bc06-0d47-6e67-e044-00144f67d249_DISS-9d85bc06-0d47-6e67-e044-00144f67d249.html

- Limonene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html

- Delta-3 -carene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ead810f-31dc-543d-e044-00144f67d031/DISS-9ead810f-31dc-543d-e044-00144f67d031_DISS-9ead810f-31dc-543d-e044-00144f67d031.html

- Germacrene delta:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-dffb4072-e289-47ae-e044-00144f67d031/DISS-dffb4072-e289-47ae-e044-00144f67d031_DISS-dffb4072-e289-47ae-e044-00144f67d031.html


Migrated from Short description of key information:
Skin sensitisation: skin sensitizer, based on the presence of classified ingredients.

Justification for selection of skin sensitisation endpoint:
Available data on composition indicates that the criteria are met for classification as skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

Pinus pinaster oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the typical composition provided by the Lead Registrant, Pinus pinaster oil is classified as skin sensitizer:

- May cause sensitisation by skin contact (Xi; R43) according to the Directive 1999/45/EEC,

- Skin Sens. 1B, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP).

No information was available regarding respiratory sensitisation.