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Diss Factsheets
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EC number: 284-294-8 | CAS number: 84837-14-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Thymus mastichina, Labiatae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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 is based on calculation rules for mixtures of the CLP Regulation, as this UVCB substance contains 10 constituents at a concentration above or equal to 1% as a mixture. There is no experimental study on the test item.
However, constituents data exist regarding skin sensitization.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Test material
- Reference substance name:
- Dipentene
- EC Number:
- 205-341-0
- EC Name:
- Dipentene
- Cas Number:
- 138-86-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-methyl-4-prop-1-en-2-ylcyclohexene
- Test material form:
- liquid
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:
- EC3
- Remarks:
- %
- Value:
- < 10
- Remarks on result:
- other: source RIFM 2009
- Parameter:
- EC3
- Remarks:
- M (molar concentration)
- Value:
- < 0.73
- Remarks on result:
- other: source RIFM 2009
- Parameter:
- EC3
- Remarks:
- oxidised 10 weeks
- Value:
- 3
- Remarks on result:
- other: source : Christensson J B, Johansson S, Hagvall L, Jonsson C, Borje A, Karlberg A T. Limonene hydroperoxide analogues differ in allergenic activity. Contact Dermatitis 2008: 59: 344-52.
- Parameter:
- EC3
- Remarks:
- pure (not oxidised)
- Value:
- 30
- Remarks on result:
- other: source : Christensson J B, Johansson S, Hagvall L, Jonsson C, Borje A, Karlberg A T. Limonene hydroperoxide analogues differ in allergenic activity. Contact Dermatitis 2008: 59: 344-52.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Limonene (synonym dipentene) is classified as a skin sensitising substance according to CLP and GHS criteria.
No study was conducted on the marjorm oil iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and limonene represents 1 to 6% of this UVCB substance (typical value at 2.1%).
Literature above provided data for this compound. - Executive summary:
The marjoram 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 (Limonene at 2.1% of typical value) according to LLNA data and according to annex 6 of regulation 1272/2008 with a harmonized classification as H317.
Limonene 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.
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.
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