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EC number: 281-658-8 | CAS number: 84012-13-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Arctium lappa, Compositae.
- 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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Arctium lappa, ext.
- EC Number:
- 281-658-8
- EC Name:
- Arctium lappa, ext.
- Cas Number:
- 84012-13-5
- IUPAC Name:
- Arctium lappa, ext.
- Details on test material:
- - Name of test material (as cited in study report): Klettenfruchtextrakt (Sample ID: 14261)
- Physical state: honey-like, yellow liquid
- Expiration date of the lot/batch: 26-SEP-2007
- Storage condition of test material: room temperature, light protected
Constituent 1
Method
- Target gene:
- TA 1537: his C 3076
TA98: his D 3052
TA1535: his G 46
WP2 uvrA: trp
TA100: his G46
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Positive control substance: sodium azide, 10 µg/plate (without metabolic activation)
Positive control substance: 2-aminoanthracene, 2.5 µg/plate (with metabolic activation) - Additional strain / cell type characteristics:
- other: Strain is histidine-dependent
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Positive control substance: sodium azide, 10 µg/plate (without metabolic activation)
Positive control substance: 2-aminoanthracene, 2.5 µg/plate (with metabolic activation) - Additional strain / cell type characteristics:
- other: Strain is histidine-dependent
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- Positive control substance: 4-nitro-o-phenylene-diamine, 50 µg/plate (without metabolic activation)
Positive control substance: 2-aminoanthracene, 2.5 µg/plate (with metabolic activation) - Additional strain / cell type characteristics:
- other: Strain is histidine-dependent
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Positive control substance: 4-nitro-o-phenylene-diamine, 10 µg/plate (without metabolic activation)
Positive control substance: 2-aminoanthracene, 2.5 µg/plate (with metabolic activation) - Additional strain / cell type characteristics:
- other: Strain is histidine-dependent
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Positive control substance: methyl methane sulfonate, 3 µL/plate (without metabolic activation)
Positive control substance: 2-aminoanthracene, 10 µg/plate (with metabolic activation) - Additional strain / cell type characteristics:
- other: Strain carries defect on genes for tryptophan biosynthesis
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/β-Naphthoflavone induced rat liver S9, prepared from 8-12 weeks old male Wistar Hanlbm rats
- Test concentrations with justification for top dose:
- Pre-experiment for toxicity was performed with TA 1535, TA 1537, TA 98, TA 100 and WP2 urvA. 8 concentrations (3 - 5000 µg/plate).
Main test: 33, 100, 333, 1000, 2500, 5000 µg/plate
Test item was dissolved in DMSO on the day of experiment. - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: relative non-toxicity to the bacteria
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: at least 48 hours at 37°C in the dark - Evaluation criteria:
- Test item considered to be mutagen if increase in number of revertants exceeding treshold of twice (TA 98, TA 100, WP2 uvrA) or thrice (TA 1535, TA 1537) the colony count of corresponding solvent control.
A dose dependent increase is considered biologically relevant if the treshold is exceeded at more than one concentration.
An increase exceeding he treshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. - Statistics:
- Not mandatory according to Guideline
Results and discussion
Test results
- Key result
- Remarks on result:
- other: No substantial increase in revertant colony numbers of any of the five strains was observed at any dose level, neither in presence nor absence of metabolic activation.
- Remarks:
- No tendency of higher mutation rates with increasing concentrations.
Any other information on results incl. tables
No substantial increase in revertant colony numbers of any of the five strains was observed at any dose level, neither in presence nor absence of metabolic activation. No tendency of higher mutation rates with increasing concentrations.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Klettenfruchtextrakt is considered to be non-mutagenic in the bacterial gene mutation test system. - Executive summary:
According to OECD 471 Klettenfruchtextrakt was dissolved in DMSO and tested with the 4 strains of Salmonella typhimurium (TA100, TA98, TA1535 and TA1537) and Escherichia coli WP2 uvr A.
Neither with nor without metabolic activation with S-9 induction of mutagenic activity was observed. Adequate positive and negative control substances were included in the test system.
Up to and including concentrations of 5000 µg/plate Klettenfruchtextrakt did not increase the mutation frequency of the 5 tested strains and is therefore considered to be non-mutagenic.
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