Registration Dossier
Registration Dossier
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EC number: 283-268-3 | CAS number: 84603-69-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Juniperus communis, Cupressaceae.
Endpoint summary
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
- 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 Juniper oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, Germacrene delta, Terpinolene) and are all present above the generic concentration limit of 1% that triggers classification of the mixture. Therefore Juniper oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 criteria.
Reference
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 (2017) was used to determine the skin sensitising potential of Juniper oil.
Some ingredients of Juniper oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, Germacrene delta, Terpinolene) and are all present above the generic concentration limit of 1%. Therefore Juniper oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 criteria.
This conclusion is supported by a positive reaction to Juniper oil in human patient (Rudzki, 1976) already reactive to other NCS such as balsam of Peru or turpentine (Rudzki, 1976).
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
- 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
- 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
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
Juniper 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, Juniper oil is classified as skin sensitizer:
- Skin Sens. 1, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
No information was available regarding respiratory sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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