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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.
- 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
Skin sensitisation: skin sensitiser, based on classified constituents.
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:
- 1985
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Non adjuvant method, relevant deficiencies. Uncovered test site. Application site changed if very strong reactions provoked. No detail on test results / dose tested and selection.
- 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:
- Open epicutaneous test
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300-450 g - Route:
- epicutaneous, open
- Vehicle:
- other: unchanged or concurrent vehicle
- Concentration / amount:
- Range finding tests: 100, 30, 10, 3 and 1 %
Main test:
- Induction phase: 100, 30, 10, 3, 1 and 0.3 %
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations - Route:
- epicutaneous, open
- Vehicle:
- other: unchanged or concurrent vehicle
- Concentration / amount:
- Range finding tests: 100, 30, 10, 3 and 1 %
Main test:
- Induction phase: 100, 30, 10, 3, 1 and 0.3 %
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations - No. of animals per dose:
- At least 6 animals in each treatment group (maximum: 20) and 10 animals in control group
- Details on study design:
- RANGE FINDING TESTS: On a day before starting the exposure (Day -1), a single application of 0.025 mL of each test concentration (100, 30, 10, 3 and 1 %) was simultaneously performed on clipped flank skin (2 cm2) of 6-8 animals and the reactions were recorded after 24 h. The minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Test groups: Open epicutaneous application of 0.1 mL of each test concentration (100, 30, 10, 3, 1 and 0.3 %)
- Control group: No treatment or topical (uncovered) application of 0.1 mL of vehicle
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. When very strong skin reactions were provoked, the application sites were changed.
- Duration: Days 0-20
- Evaluation: Dermal reactions were recorded at 24 h after each application or at the end of each week and the minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Days 21 and 35
- Test and control groups: Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material
- Site: Contralateral flank (2 cm2)
- Evaluation (h after challenge): 24, 48 and/or 72 h - Challenge controls:
- Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on control animals during challenge phase.
- Positive control substance(s):
- not specified
- Positive control results:
- Not applicable
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the test conditions, Eucalyptus oil was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
- Executive summary:
In an open epicutaneous test (OET), groups of guinea pigs were topically (uncovered) induced with 0.1 mL of Eucalyptus oil at doses of 100, 30, 10, 3, 1 and 0.3 % on clipped flank skin (8 cm2), daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. The application sites were changed if very strong skin reactions were provoked. At least 6 animals were used in each treatment group and 10 animals in control group. On Days 21 and 35, an open epicutaneous challenge application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on the contralateral flank (2 cm2) of the animals and the dermal reactions were recorded after 24, 48 and/or 72 h.
Under the test conditions, Eucalyptus oil was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
- 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
- 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 1B
- 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.
Referenceopen allclose all
No positive reaction was observed after challenge exposure.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Eucalyptus globulus oil is not a skin sensitiser in the available study performed using a non-adjuvant method (Klecak, 1985). However relevant methodological deficiencies were noticed, questioning the reliability of the result.
Indeed 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; alpha pinene, dipentene ...) 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.
Migrated from Short description of key information:
Skin sensitiser, based on constituents concentration.
Justification for selection of skin sensitisation endpoint:
Available data indicates that the criteria are met for classification as skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
This information is not available
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.
Self-classification:
Based on the available information the substance is classified as:
- May cause sensitisation by skin contact (Xi; R43) according to the criteria of the Annex VI of the Directive 67/548/EEC,
- Skin Sens. 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.
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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