Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 948-910-5 | CAS number: -
Skin sensitisation
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
- Reliability:
- 2 (reliable with restrictions)
- 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:
- 2 017
- 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
- Reference substance name:
- Essential oil of Tanacetum annuum
- IUPAC Name:
- Essential oil of Tanacetum annuum
- Test material form:
- liquid
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: classification
- Remarks on result:
- other: Skin sensitization category 1 - H317
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sensitization category 1 - H317
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Blue Tansy oil contains constituents that are classified as skin sensitisers Cat.1 and are all potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1
- Executive summary:
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 Blue Tansy oil.
Blue Tansy oil has not been tested itself in vitro/in chemico or in vivo, but some individual constituents of this UVCB are suspected or have been classified as skin sensitizers (see table) and are all present or potentially present above the generic concentration limit of 1 %. Therefore the substance shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 127212008.
Source: ECHA disseminated dossiers
Skin sensitization category 1 - H317 classified constituents:
Beta pinene (typ. 4%)
Alpha pinene (typ. 2%)
Myrcene (typ. 2.5%)
Caryophyllene (typ. 1.6%)
Limonene (typ. 1.5%)
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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