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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation: skin sensitizer, based on available human data and the presence of classified ingredients.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
Classification based on calculation rules for mixtures of the CLP Regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
accepted calculation method
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Key result
Parameter:
other: Classification
Remarks on result:
other: Skin sensitiser category 1
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Executive summary:

The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2017) was used to determine the skin sensitising potential of the registered substance.

Some ingredients of Cypress oil have been classified as skin sensitizers Cat.1 and 1.B (pinene alpha and beta, delta 3 -carene, Terpinolene, limonene) and are all present above the generic concentration limit of 1%. Therefore Fir silver oil shall be classified as askin sensitizer Cat.1without further testing according to the Regulation (EC) No 1272/2008.

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

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


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:

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

No information was available regarding respiratory sensitisation.