Registration Dossier
Registration Dossier
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EC number: 285-397-0 | CAS number: 85085-75-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Thymus zygis, Labiatae.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- Classification based on calculation rules for mixtures of the CLP Regulation. There is no experimental study reference.
Available data upon constituants come from Opinion proposing harmonised classification and labelling at EU level of linalool from Committee for Risk Assessment (RAC) 2015
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Linalool
- EC Number:
- 201-134-4
- EC Name:
- Linalool
- Cas Number:
- 78-70-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 8.3
- Remarks on result:
- other: for sample 100% linalool commercial grade
- Parameter:
- SI
- Value:
- 4.9
- Remarks on result:
- other: for sample 100% linalool (purified, redistilled)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Linalool is classified as a skin sensitising substance according to CLP and GHS criteria.
No study was conducted on the thymus zygis oil itself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalool represents 3.6% of this UVCB substance. - Executive summary:
The thyme oil is an NCS (natural complex substance) because it is composed of several identified constituents. Therefore, 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 sensitizing potential of the registered substance.
The registered substance has not been tested itself in appropriate in vitro or in vivo tests but one of its constituents is classified as skin sensitizing (Linalool at 3.6%) according to LLNA data and according to annex 6 of regulation 1272/2008 with a harmonized classification in H317.
Linalool is present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensiting substance 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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