Registration Dossier
Registration Dossier
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EC number: 284-524-7 | CAS number: 84929-41-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Piper nigrum, Piperaceae.
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: skin sensitizer, based on the presence of classified consituents.
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
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- 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: Classification based on calculation rules
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Essential oil of Piper nigrum (Piperaceae) obtained from the berries by steam distillation shall be classified as a skin sensitizer cat.1 without further testing based on calculation rules for mixtures according to the Regulation (EC) No 1272/2008 and the Directive 1999/45/EEC.
- 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.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin sensitisers Cat.1 or Cat.1B (alpha pinene, limonene, beta caryophyllene, carene...) and are all present above the generic concentration limit of 1%. Therefore Essential oil of Piper nigrum (Piperaceae) obtained from the berries by steam distillation shall be classified as a skin sensitizer cat.1 without further testing according to the Regulation (EC) No 1272/2008 and the Directive 1999/45/EEC.
- alpha pinene: Registration Dossier - ECHA (europa.eu)
- Limonene: Registration Dossier - ECHA (europa.eu)
- Beta caryophyllene: Registration Dossier - ECHA (europa.eu)
- Carene: Registration Dossier - ECHA (europa.eu)
Source: ECHA disseminated dossiers
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
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.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin sensitisers Cat.1 or Cat.1B (alpha pinene, limonene, beta caryophyllene, carene...) and are all present above the generic concentration limit of 1%. Therefore Essential oil of Piper nigrum (Piperaceae) obtained from the berries by steam distillation shall be classified as a skin sensitizer cat.1 without further testing according to the Regulation (EC) No 1272/2008 and the Directive 1999/45/EEC.
- alpha pinene: Registration Dossier - ECHA (europa.eu)
- Limonene: Registration Dossier - ECHA (europa.eu)
- Beta caryophyllene: Registration Dossier - ECHA (europa.eu)
- Carene: Registration Dossier - ECHA (europa.eu)
Source: ECHA disseminated dossiers
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self-classification:
Based on the typical composition provided by the Lead Registrant, the registered substance is classified as skin sensitiser: Skin Sens.1, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
