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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
Endpoint summary
Administrative data
Description of key information
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 Camphor white oil.
Camphor white oil is not a skin sensitiser in the available study performed using a non-adjuvant method (Sharp, 1978). However relevant methodological deficiencies were noticed, questioning the reliability of the result.
Indeed, some ingredients of Camphor white oil have been 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 all present above the generic concentration limit of 1%.
Therefore Camphor white oil shall be classified as a Skin sensitizer Cat. 1 without further testing according to the Regulation (EC) No 1272/2008.
This conclusion is supported by a human case-report (Stevenson, 2003) in which positive reactions was observed following the cutaneous application of Camphor white oil at 10% in petrolatum.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 1978
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Modified Draize procedure using 10 animals in test group instead of 20. Morevoer, some of the substances tested that were shown to be non-sensitizer under the study conditions are currently classified as skin sensitizer, so the test method is not considered to be reliable enough for the purpose of hazard assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- Modified Draize Procedure
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Type of study:
- other: modified draize procedure
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS (10 animals)
- Weight at study initiation: 350 g
- Housing: Animals were housed in pairs of same sex in wire mesh cages
- Diet: Pelleted guinea pig diet, cabbage and hay, ad libitum
- Water, ad libitum - Positive control results:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Camphor white oil was found to be a non-sensitiser to skin of guinea pigs in a modified draize procedure.
- Executive summary:
In a modified draize procedure, ten guinea pigs were intradermally induced with 0.1 mL aliquots of Camphor white oil at 2.5 times the ICC at 4 sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. Fourteen days later each animal was challenged intradermally in one flank and topically (uncovered) in the other flank with 0.1 mL aliquots of test substance at the respective ICC (0.15 %) and ACC (30 %). Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included. At each challenge with controls, 4 previously untreated animals of the same sex were treated intradermally and topically on opposite flanks with 0.1 mL aliquots of test substance at the ICC and ACC respectively. Preliminary study was conducted to determine the concentrations for main study.
Camphor white oil at 0.15 % (ICC) and 30 % (ACC) did not cause skin sensitization.
Under the test conditions, Camphor white oil was found to be a non-sensitiser to skin of guinea pigs in a modified draize procedure.
- 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
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Classification based on calculation rules for mixtures of the CLP Regulation
- Key result
- Parameter:
- other: Classification
- Remarks on result:
- other: Skin sensitiser category 1
- 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.
Referenceopen allclose all
Camphor white oil at 0.15 % (ICC) and 30 % (ACC) did not cause skin sensitization.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
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 Camphor white oil.
Camphor white oil is not a skin sensitiser in the available study performed using a non-adjuvant method (Sharp, 1978). However relevant methodological deficiencies were noticed, questioning the reliability of the result. Indeed, some ingredients of Camphor white oil have been 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 all present above the generic concentration limit of 1%.
Therefore Camphor white oil shall be classified as a Skin sensitizer Cat.1 without further testing according to the Regulation (EC) No 1272/2008, because sub-categories does not exist for the classification of the sensitisation hazard of mixtures.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
Camphor white oil has no harmonized classification according to the Regulation (EC) No. 1272/2008 and the GHS.
Self-classification:
Based on the typical composition provided by the Lead Registrant, Camphor white oil is classified as a Skin Sensitiser Cat. 1, H317 (May cause an allergic skin reaction) according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
No information was available regarding respiratory sensitisation.
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