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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted: 17th December 2001
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment No 24, 2001
- Version / remarks:
- No 24, 2001
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
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:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dobrá Voda, Slovak Republic
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 173-186g for females
- Fasting period before study: overnight before treatment
- Housing: 3 animals per cage in a room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): The animals received tap water for human consumption. Supply of drinking was unlimited.
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.58 ± 0.56 °C
- Humidity (%): 54.31 ± 2.71 %
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12-hour light /12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Animals were treated orally, with a single dose by means of a stomach tube.( Oral administration simulates a potential route of human exposure, and oral dosing is recommended by regulatory agencies.)
- Doses:
- 2000 mg/kg body weight
- Control animals:
- no
- Details on study design:
- Clinical signs of toxicity, physical condition, and rate of death was monitored throughout the 14-day observation period.
All test animals were subjected to gross necropsy and the results were recorded for each animal whenever they died, survivors at the end of the observation period.
Individual weights of animals were measured immediately prior to test item administration and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - <= 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The 95% CL is not available
- Remarks:
- The 95% CL is not available
- Mortality:
- 5/6 animals survived the limit dose of 2000 mg/kg body weight.
- Clinical signs:
- other: Test item-related mortality was observed within 24 hours. Animal No 6 died one day after administration of the test item probably during the night hours, because cadaver was in a state of autolysis. In animals No 1, 2, 3, 5 piloerection and lethargy were
- Gross pathology:
- During necropsy, no macroscopic findings were observed. Animal No 6 could not be necropsied because of autolysed cadaver.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of the test item Star anise, Illicium verum, ext. is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Star anise, Illicium verum, ext is according to Globally Harmonized System classified in Category 5 with a LD50 cut off value 2500 mg/kg body, after single oral administration to Wistar rats. - Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test itemStar anise, Illicium verum, ext.when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class(ATC)method was used.
A limit dose of 2000 mg/kg body weight was used as a starting dose.The test itemadministeredto 6 females at a limit dose caused death of one animal. Piloerection and lethargy were observed during the observation period. A slight decrease of body weights in two animals was noticed during the first post-treatment week. No body weight losses were observed between the first and second week after administration.During necropsy, no macroscopic findings were observed.
The LD50of the test itemStar anise, Illicium verum, ext.is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based onAnnex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423itcan be concluded that thetest itemStar anise, Illicium verum, ext.is according toGlobally Harmonized Systemclassified in Category 5 with a LD50cutoff value 2500 mg/kg body weight,after single oral administration to Wistar rats.
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