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EC number: 310-217-5 | CAS number: 132940-73-9 Extractives and their fisically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca viridiflora, 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 September – 04 October 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD guideline 429.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- 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)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Melaleuca viridiflora extract
- EC Number:
- 310-217-5
- EC Name:
- Melaleuca viridiflora extract
- Cas Number:
- 132940-73-9
- IUPAC Name:
- Essential oil of Melaleuca viridiflora (Myrtaceae) obtained from twigs and leaves by steam distillation
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): NIAOULI Essential Oil (Melaleuca quinquenervia) 021261
- Physical state: Colourless liquid
- Analytical purity: Considered as 100 %
- Lot/batch No.: 1855343
- Date received: 06 September 2010
- Expiry date: 23 January 2011
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 19.3-22.1 g
- Housing: Individually housed in suspended solid-floor polypropylene cages
- Diet (e.g. ad libitum): Diet (M20, SDS), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 5, 10, 25, 50 and 100 % (v/v) in acetone/olive oil (4:1, v/v)
- No. of animals per dose:
- Four females
- Details on study design:
- RANGE FINDING TESTS:
- Method: In the preliminary test, a mouse was treated with daily application of 25 µL of the test item (undiluted) to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). Any signs of toxicity or excessive local irritation were recorded daily on Days 1, 2, 3, 4, 5 and 6. Ear thickness was recorded on Days 1, 3 and 6. Bodyweight of the mouse was recorded on Day 1 (prior to dosing) and on Day 6.
- Results: No systemic toxicity or excessive irritation was noted at 100 %. Therefore, the concentration of 100 % was chosen as the highest concentration for the main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: Test item would be regarded as a sensitiser if at least one concentration of the test item produce a Stimulation Index > 1.4 (SI = cell count of treated group / cell count of control group).
TREATMENT PREPARATION AND ADMINISTRATION: 25 µL of test material at concentrations of 0 (vehicle control), 5, 10, 25, 50 and 100 % (v/v) in acetone/olive oil (4:1, v/v) were applied to the dorsal surface of each ear on Days 1, 2 and 3. On Day 6, all mice were euthanized with sodium pentobarbital and the draining auricular lymph node from the four mice were excised and pooled for each experimental group. A single cell suspension of the lymph node cells of 4 mice of each group was prepared by gentle mechanical tissue disaggregation through a 200-mesh cell strainers in 4 mL of PBS (Ca2+ / Mg2+ free) containing 0.5 % BSA into a well of a multi-well 6. A volume of 10 μL of this cell suspension was diluted in 10 mL of physiological saline solution (NaCl 0.9 %). The lymphocyte cells were counted using a cell counter (Beckman Coulter Z2). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- Stimulation Index = 2.06
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- - Stimulation Index (SI) calculated by pooled approach was 1.18, 0.96, 1.01, 1.52 and 2.35 for the treated groups at 5, 10, 25, 50 and 100 %, respectively. - EC1.4 value determined by linear interpolation of points on the dose-response curve was 44.12 %.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable
Any other information on results incl. tables
- Clinical signs and mortality: No mortality and no signs of systemic toxicity were noted in the test and controls animals during the test.
- Body weight: Bodyweight changes of the test animals were comparable to those observed in the corresponding control group animals, throughout the study.
- Skin irritation and ear thickness: Slight dryness to dryness was noted on the treatment site on Day 6 in all animals treated at 100 %. No significant increase in ear thickness and in ear weight was recorded at the concentrations up to 100 %.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, NIAOULI Essential Oil (Melaleuca quinquenervia) 021261 is classified as ‘R43 May cause sensitisation by skin contact’, according to the criteria of Annex VI to the Directive 67/548/EEC and ‘Category 1’ according to the Regulation (EC) No 1272/2008 (CLP).
- Executive summary:
In a local lymph node assay performed in CBA/J strain mice according to OECD guideline 429 and in compliance with GLP, six groups of mice (4 females/dose) were applied with 25 µL of the test item, NIAOULI Essential Oil (Melaleuca quinquenervia) 021261, at concentrations of 0 (vehicle control), 5, 10, 25, 50 and 100 % (v/v) in acetone/olive oil (4:1, v/v) (AOO) to the dorsal surface of each ear for three consecutive days. A group of 4 mice was treated with a positive control (alpha-hexylcinnamaldehyde) diluted at 25 % (v/v) in AOO. On Day 6, all animals were sacrificed and the proliferation of lymphocytes in the draining auricular lymph nodes was determined by cell counting.
No mortality or clinical sign of toxicity was noted at any dose level. No significant increase in ear thickness and in ear weight was recorded at any dose level. Stimulation Index (SI) calculated by pooled approach was 1.18, 0.96, 1.01, 1.52 and 2.35 for the treated groups at 5, 10, 25, 50 and 100 %, respectively, and EC1.4 value was determined to be 44.12 %. The SI value for the positive control was 2.06.
Under the test conditions, NIAOULI Essential Oil (Melaleuca quinquenervia) 021261 is classified as ‘R43 May cause sensitisation by skin contact’, according to the criteria of Annex VI to the Directive 67/548/EEC and ‘Category 1’ according to the Regulation (EC) No 1272/2008 (CLP).
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