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EC number: 943-438-6 | CAS number: 90063-59-5
- 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:
- No data available
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to OECD guideline 429 and under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation
- EC Number:
- 943-438-6
- Cas Number:
- 90063-59-5
- IUPAC Name:
- Essential oil obtained from the fruits of Litsea cubeba (Lour.) Pers. by distillation
- Test material form:
- liquid
1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK Limited, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: Young adults (no specific data available)
Weight at study initiation: 17.1-20.3 g (1 animal with weight of 10.5 g, was possibly mis-weighed)
- Housing: Maximum of 4 mice per cage, under standard laboratory conditions
- Diet: Ad libitum, RM1 diet
- Water: Ad libitum, mains water
- Acclimation period: At least 5 days prior to start of dosing (under experimental conditions)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No data available
Study design: in vivo (LLNA)
- Vehicle:
- other: 1:3 ethanol:diethyl phthalate
- Concentration:
- 2.5%, 5%, 10%, 25%, 50% w/v and concurrent vehicle
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS: No data available
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD guideline 429 was followed.
- Criteria used to consider a positive response: Increased T-lymphocyte proliferation in the test groups as compared to the concurrent vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION:
All dose preparations were used within 24 hours of preparation. No correction was made based on the purity of the active ingredient in the test substance (purity not determined). Stability and achieved concentration were not determined. 25 uL of vehicle or Litsea cubeba oil in vehicle at a concentration of 2.5% -5% -10% - 25% or 50% w/v was applied to the dorsal surface of each ear during 3 consecutive days. Three days after the last application, the mice were injected with approx. 250 µl of PBS containing 3H-methyl thymidine (20 µCi).
ANALYSIS OF LYMPHOCYTE PROLIFERATION
Five hours after injecting radiolabelled thymidine animals were sacrificed (halothane inhalation). The lymph nodes of the mice in the same group were pooled, washed with PBS and resuspended in TCA before counted by liquid scintillation.
EXAMINATIONS
- Signs of systemic toxicity: checked at least once daily
- Bodyweights: recorded prior to dosing (day 1) and prior to injection of 3H-thymidine (day 6)
DATA EVALUATION
The disintegrations per minute (dpm) value was determined for each test group. This information was used to calculate the Stimulation Index (SI) for each of the test groups (disintegrations per minute of treatment group / disintegrations per minute of control group). A positive respons is indicated when one or more test groups shows a SI of 3. The EC3 value is the concentration at which a 3-fold increase of lymph node proliferation is observed. Interpolation is used to determine the EC3 value between two test concentrations.
POSITIVE CONTROL
Male mice were treated with 25 uL of acetone or 1%, 3% or 10% hexyl cinnamic aldehyde in acetone, using the same method as for the test groups. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- - Calculation of the Stimulation Index per treatment group
- Determination of the EC3 value (by interpolation)
Results and discussion
- Positive control results:
- A dose-related response (increase of Stimulation Index; or SI) was observed for the three treatment groups as compared to the control group. The SI was >3 for the 2 highest concentrations applied, indicating that the study protocol is valid for determination of the substance potential to sensitize in mice.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: - 2.5% treatment group: 2.09 - 5% treatment group: 2.35 - 10% treatment group: 3.31 - 25% treatment group: 7.96 - 50% treatment group: 16.03
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: - Control group: 4866 dpm - 2.5% treatment group: 10143 dpm - 5% treatment group: 11431 dpm - 10% treatment group: 16087 dpm - 25% treatment group: 38734 dpm - 50% treatment group: 77974 dpm
- Key result
- Parameter:
- EC3
- Remarks:
- % (w/v)
- Value:
- 8.4
Any other information on results incl. tables
A dose-related increase in Stimulation Index was observed for the groups treated with Litsea cubeba oil. The EC3 value was determined to be 8.4% w/v.
Applicant's summary and conclusion
- Interpretation of results:
- other: Sensitising
- Remarks:
- in accordance with the criteria outline in Annex I of 1272/2008/EC (CLP)
- Conclusions:
- In this study, treatment with Litsea cubeba oil was found to significantly induce lymph node proliferation in mice as compared to controls. The Stimulation Index showed a dose-related increase and the EC3 value was determined to be 8.4% w/v (based on interpolation between the 5% and 10% w/v dose). Based on this EC3 value, the substance should be classified as skin sensitiser (Cat. 1B) in accordance with the criteria outline in Annex I of 1272/2008/EC (CLP).
- Executive summary:
This Local Lymph Node Assay (LLNA) was performed according to the methods outlined in OECD guideline 429. Four mice per group were treated with 0%, 2.5%, 5%, 10%, 25% or 50% Litsea Cubeba oil in 1:3 ethanol:diethyl phthalate (vehicle) for three consecutive days, followed by in vivo radiolabelling (by injection) and lymphocyte proliferation analysis with the liquid scintillation counter. The number of disintegrations per minute (dpm) was determined for each group for the pooled lymph nodes.
Treatment with Litsea Cubeba oil was found to significantly induce lymph node proliferation in mice as compared to controls. The Stimulation Index (SI) was calculated for the treatment groups (dpm treatment group / dpm control group) and a dose-related increase in SI was observed for the animal groups treated with Litsea cubeba oil. The EC3 value was calculated to be 8.4% w/v based on interpolation between the 5% and 10% w/v dose.
Based on the EC3 value of 8.4% that was found in this study, the substance should be classified as skin sensitiser (Cat. 1B) in accordance with the criteria outline in Annex I of 1272/2008/EC (CLP).
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