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EC number: 283-518-1 | CAS number: 84650-59-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Illicium verum, Illiciaceae.
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study planned
- Study period:
- 2021.1.1 - 2022.1.1
- Justification for type of information:
- Public substance name: Star anise, Illicium verum, ext.
EC Number: 283-518-1
CAS Number: 84650-59-9
Date of considerations: 29 June 2020
Hazard endpoint for which vertebrate testing was proposed:
In vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information
(instruction: please address all points below):
Available GLP studies
No available GLP studies on the substance for the endpoint ‘Genetic toxicity in vivo’.
Available non-GLP studies
No available non-GLP studies on the substance for the endpoint ‘Genetic toxicity in vivo’.
Historical human data
No human data suggesting Genetic toxicity in vivo are available for this substance.
(Q)SAR
No validated (Q)SAR exists for this endpoint. There is no known mode of action for Star anise, Illicium verum, ext. causing Genetic toxicity in vivo.
In vitro methods
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment. With regards to studies for Genetic toxicity in vivo, the regulatory acceptance of these studies and approaches to replace the animal testing for Genetic toxicity in vivo has not been achieved as they do not provide equivalent information and thus, cannot be used alone for classification and labeling and/or risk assessment.
Weight of evidence
No available ‘weight of evidence’ data on the substance for the endpoint ‘Genetic toxicity in vivo’.
Grouping and read-across
No data exists on analogous substances. It is the intention to use test data from Genetic toxicity in vivo for further read-across to similar substances thus avoiding the need to perform further testing.
Substance-tailored exposure driven testing [if applicable]
Not applicable
Approaches in addition to above [if applicable]
Not applicable
Other reasons [if applicable]
Not applicable
Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable (instruction: free text):
Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- (E)-anethole
- EC Number:
- 224-052-0
- EC Name:
- (E)-anethole
- Cas Number:
- 4180-23-8
- Molecular formula:
- C10H12O
- IUPAC Name:
- 1-methoxy-4-prop-1-en-1-ylbenzene
- Reference substance name:
- 4-allylanisole
- EC Number:
- 205-427-8
- EC Name:
- 4-allylanisole
- Cas Number:
- 140-67-0
- Molecular formula:
- C10H12O
- IUPAC Name:
- 1-allyl-4-methoxybenzene
- Reference substance name:
- Caryophyllene
- EC Number:
- 201-746-1
- EC Name:
- Caryophyllene
- Cas Number:
- 87-44-5
- Molecular formula:
- C15H24
- IUPAC Name:
- 4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Reference substance name:
- 2,6-dimethyl-6-(4-methyl-3-pentenyl)bicyclo[3.1.1]hept-2-ene
- EC Number:
- 241-702-9
- EC Name:
- 2,6-dimethyl-6-(4-methyl-3-pentenyl)bicyclo[3.1.1]hept-2-ene
- Cas Number:
- 17699-05-7
- Molecular formula:
- C15H24
- IUPAC Name:
- 2,6-dimethyl-6-(4-methylpent-3-en-1-yl)bicyclo[3.1.1]hept-2-ene
- Test material form:
- liquid
Constituent 1
Constituent 2
1
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- All treated animals were exposed to test or control materials via the oral dose route.
The rats were weighed immediately before each exposure event and the dose volume adjusted using a graded syringe fitted with a gavage needle.
Treated animals were exposed to dosing formulations at a dose volume of 10 mL/kg/day. - Duration of treatment / exposure:
- 48h
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 7M+7F
- Control animals:
- yes
- Positive control(s):
- cyclophosphamide
Examinations
- Details of tissue and slide preparation:
- Rats were killed by increasing levels of carbon dioxide. The marrow was flushed out using a 1:1 mixture of foetal calf serum and trisodium citrate (0.8 %, w/v) in Sorenson's buffer (pH 6.8). Routine tissue culture antibiotics were included to prevent microbial growth. This mildly hypotonic treatment served to make the micronuclei clearly visible and to distinguish them from surrounding artefacts. Following completion of the sampling procedure the contents of the tubes were briefly agitated on a vortex mixer to allow separation of the cells.
The tubes were centrifuged to pellet the cells. The supernatant fluid was discarded and the cells were then resuspended on a vortex mixer in the residual liquid.
Clean slides were assigned numbers corresponding to the tube numbers. A drop of the suspension was placed at one end of the slide and a smear made by drawing the top of a Pasteur pipette horizontally along the slide. Two slides were prepared from each tube (animal). The smear was left to air dry, fixed in methanol (for at least 5 min) and then stained with Giemsa stain (15%, v/v, in water) to give optimum erythrocyte discrimination. Permanent slide preparations were made by sealing cover slips onto the glass slides using mounting medium. - Evaluation criteria:
- One of the prepared slides was selected for examination and the coded slides assessed blind by the same operator. At least two thousand polychromatic erythrocytes (PCE) per animal were scored for micronuclei and the frequency of micronucleated cells (MN-PCE) determined.
As a control against inclusion of artefacts, or action of a mutagen on the G2 and/or mitotic phase of the cell cycle, the numbers of micronucleated normochromatic erythrocytes (MN-NCE) in mature red blood corpuscles were also recorded (Maier and Schmid, 1976; Hamoud et al, 1989). In addition, scored micronuclei were assigned on the basis of size into small or large categories, historically defined as micronuclei occupying less or more than 25% of the visible cellular area. This classification provided a non-specific measure of compound induced spindle dysfunction, as large micronuclei appear to derive from lagging chromosomes caused by damage to the mitotic apparatus during bone marrow erythropoiesis (Yamamoto and Kikuchi, 1980; Vanderkerken et al, 1989). Any anomalies observed, such as large micronuclei, would be reported in the Appendix of the report.
The PCE/NCE ratio, a measure of any induced systemic toxicity, was determined by counting a minimum total of 1000 erythrocytes (PCE + NCE) per marrow preparation.
A suitable binocular microscope was used for the assessment. The scoring was done under a nominal magnification of x1250 using x12.5 magnification eye pieces and a x100 oil immersion objective.
Results and discussion
Applicant's summary and conclusion
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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