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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Data source

Reference
Reference Type:
other: Guidance
Title:
Guidance on the Application of the CLP Criteria - Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures
Author:
ECHA
Year:
2017
Bibliographic source:
ECHA-17-G-21-EN

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation

Test material

Constituent 1
Reference substance name:
Pepper (Piper), P. nigrum, ext.
EC Number:
284-524-7
EC Name:
Pepper (Piper), P. nigrum, ext.
Cas Number:
84929-41-9
Molecular formula:
Not available
IUPAC Name:
Essential oil of Piper nigrum (Piperaceae) obtained from the berries by steam distillation

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Classification
Remarks on result:
other: Classification based on calculation rules

Applicant's summary and conclusion

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