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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 283-406-2 | CAS number: 84625-32-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Eucalyptus globulus, Myrtaceae.
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:
- 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:
- 2 015
- Bibliographic source:
- ECHA-15-G-05-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:
- Eucalyptus oil globulus
- IUPAC Name:
- Eucalyptus oil globulus
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material (as cited in study report): eucalyptus oil globulus
- Molecular formula (if other than submission substance): see confidential
- Molecular weight (if other than submission substance): see confidential
- Smiles notation (if other than submission substance): see confidential
- Structural formula attached as image file (if other than submission substance): see confidential
- Substance type: Natural Complex Substance
- Physical state: see confidential
- Analytical purity: see confidential
- Impurities (identity and concentrations): see confidential
- Composition of test material, percentage of components: see confidential
- Purity test date: see confidential
- Lot/batch No.: see confidential
- Expiration date of the lot/batch: see confidential
- Storage condition of test material: room temperature
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: classification
- Remarks on result:
- other: skin sensitiser category 1B
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) 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 (2015) 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.1B (cineol 1,8; dipentene, alpha pinene...) 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. 1B without further testing according to the Regulation (EC) No 1272/2008.
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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