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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 Cypress oil.

Some ingredients of Cypress oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, delta 3 carene, Terpinolene) and are all present above the generic concentration limit of 1%. Therefore Cypress 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.

This conclusion is supported by a human prick test (Mari, 1996) on the pollen of the plant from which the NCS to be registered is extracted in which positive reactions were observed in 31.5% of patients tested with an in-house extract of Cupressaceae pollinosis and 29.5% has positive results to the commercial extract.

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

- Terpinolene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031_DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031.html


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

Justification for selection of skin sensitisation endpoint:
Available data 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:

Cypress 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, Cypress 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.

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