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EC number: 295-980-1 | CAS number: 92201-50-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cinnamomum camphora, Lauraceae.
- 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
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
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
- Type of sensitisation studied:
- skin
- Study type:
- other: case report and patch testing
- Principles of method if other than guideline:
- A 64 year-old woman presented with severe eczema of the ears, neck and upper chest following the use of Earex ear drops containing rectified camphor oil along with other ingredients. Patch testing was performed with ear drops and rectified camphor oil (10 % in petrolatum) and skin reactions were observed. Subsequently, a further 30 patients attending the patch test clinic were tested to the same rectified camphor oil.
- GLP compliance:
- no
- Type of population:
- general
- Controls:
- None
- Route of administration:
- dermal
- Results of examinations:
- - One female (n=1) showed positive reactions on Day 2 and Day 4 to 10 % camphor oil in petrolatum.
- A further 30 patients attending the patch clinic were tested to the same camphor oil as is and none developed positive reactions. - Conclusions:
- Under the test conditions, patch testing with rectified camphor oil showed one skin sensitization case in human.
- Executive summary:
In a study, a 64 year-old woman presented with severe eczema of the ears, neck and upper chest following the use of Earex ear drops containing rectified camphor oil along with other ingredients. Patch testing was performed with ear drops and rectified camphor oil (10 % in petrolatum) and skin reactions were observed. Subsequently, a further 30 patients attending the patch test clinic were tested to the same rectified camphor oil.
One female (n=1) showed positive reactions on Day 2 and Day 4 to 10 % camphor oil in petrolatum. A further 30 patients attending the patch clinic were tested to the same camphor oil as is and none developed positive reactions.
Under the test conditions, patch testing with rectified camphor oil showed one skin sensitization in human.
None
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:
- Camphor tree, ext.
- EC Number:
- 295-980-1
- EC Name:
- Camphor tree, ext.
- Cas Number:
- 92201-50-8
- IUPAC Name:
- 1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Classification
- Remarks on result:
- other: Skin sensitiser category 1
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) 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 (2017) was used to determine the skin sensitising potential of the registered substance.
The registered substance has been tested itself in an in vivo test but the study has been disregarded. Moreover, some of its constituents are classified as skin sensitisers Cat.1 and 1B (Dipentene, cineol 1,8, pinene alpha, pinene beta, 7-methyl-3-methyleneocta-1,6-diene, p-menth-1-en-4-ol, p-mentha-1,4(8)-diene and 5-isopropyl-2-methylbicyclo[3.1.0]hex-2-ene) and are 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, without further testing according to the Regulation (EC) No 1272/2008 because sub-categories does not exist for the classification of the sensibilisation hazard of mixtures.
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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