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EC number: 942-403-2 | CAS number: -
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 January - 23 March 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 476 with minor deviation: In Experiment 1 in the presence of S-9, only three concentrations were analysed for mutant frequency instead of four concentrations.
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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- In Experiment 1 in the presence of S-9, only three concentrations were analysed for mutant frequency instead of four concentrations.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- ethanol water extract from husk of Chenopodium quinoa, Chenopodiaceae
- IUPAC Name:
- ethanol water extract from husk of Chenopodium quinoa, Chenopodiaceae
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: MEXORYL SCK
- Physical state: Beige powder
- Analytical purity: saponines content (determined by HPLC assay) 55.8 % w/w
- Lot/batch No.: R0069579A 003 P 001
- Shelf life/Retest date: April 2011
- Storage condition of test material: Stored at room temperature and away from light and moisture
Constituent 1
Method
- Target gene:
- hprt gene
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Growth media, RPMI 1640
RPMI A: Penicillin (100 units/mL), streptomycin (100 μg/mL), amphotericin B (2.5 μg/mL) and pluronic (0.5 mg/mL)
RPMI 10: Horse serum (heat inactivated, 10 % v/v), penicillin (100 units/mL), streptomycin (100 μg/mL), amphotericin B (2.5 μg/mL) and pluronic (0.5 mg/mL)
RPMI 20: Horse serum (heat inactivated, 20 % v/v), penicillin (100 units/mL), streptomycin (100 μg/mL) and amphotericin B (2.5 μg/mL)
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: Yes
- Periodically checked for spontaneous mutant frequency: Yes
- Other details: For each experiment, one vial was thawed and the cells diluted in RPMI 10 and incubated in a humidified atmosphere of 5 % v/v CO2 in air. The cells were allowed to grow well and subcultures were established in an appropriate number of flasks. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 2 % S9; S9 fraction was prepared from liver homogenates of male Sprague Dawley rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Range-finder experiment:
- With and without S9 mix: 156.3, 312.5, 625, 1250, 2500 and 5000 μg/mL
Main study:
- Experiment 1: 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000, 4500 and 5000 μg/mL, with and without S9 mix
- Experiment 2: 500, 1000, 2000, 2500, 3000, 3500, 3750, 4000, 4500 and 5000 μg/mL, with and without S9 mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Purified water
- Test article solutions were prepared by formulating MEXORYL SCK under subdued light conditions in purified water (with the aid of vortex mixing, warming at 37 ºC, ultrasonication and stirring as required) immediately prior to assay to give the maximum required treatment solution concentration. The stock solutions were membrane filter-sterilised (Pall Acrodisc 32 filter, 0.2 μm pore size) and subsequent dilutions made using purified water. The test article solutions were protected from light and used within 1.5 h of initial formulation of the test article.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- treatments with the vehicle purified water diluted 10-fold in the treatment medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 0.1 and 0.15 μg/mL; without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- treatments with the vehicle purified water diluted 10-fold in the treatment medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 2 and 3 μg/mL; with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In RPMI 1640 media (RPMI A, RPMI 5, RPMI 10, RPMI 20)
DURATION
- Exposure duration: 3 h, 37 ± 1 ºC
- Expression time (cells in growth medium): 7 days, 37 ± 1 ºC in a humidified incubator gassed with 5 % v/v CO2 in air
- Viability scoring: 8 days, 37 ± 1 ºC in a humidified incubator gassed with 5 % v/v CO2 in air
- Selection time (if incubation with a selection agent): 12-14 days, 37 ± 1 ºC in a humidified incubator gassed with 5 % v/v CO2 in air
SELECTION AGENT (mutation assays): 6-thioguanine (6-TG) at 15 µg/mL (final concentration)
NUMBER OF REPLICATIONS:
- Vehicle control and test substance groups: Single culture for cytotoxicity study and duplicate cultures for experiment 1 and 2.
- Positive control: Single culture for experiments 1 and 2.
NUMBER OF CELLS EVALUATED: 1.6, 1.6 and 20000 cells per well plated for survival, viability and 6-TG resistance respectively.
DETERMINATION OF CYTOTOXICITY
- Method: Percentage Relative Survival (%RS)
OTHER:
- Wells containing viable clones were identified by eye using background illumination and counted.
- Cell concentrations in the selected cultures were determined using a Coulter counter. - Evaluation criteria:
- For valid data, the test article was considered to induce forward mutation at the hypoxanthine phosphoribosyl transferase (hprt) locus in mouse lymphoma L5178Y cells if:
- the mutant frequency at one or more concentrations was significantly greater than that of the negative control (p≤0.05)
- there was a significant concentration-relationship as indicated by the linear trend analysis (p≤0.05)
- the effects described above were reproducible.
- Results that only partially satisfy the assessment criteria described above were to be considered on a case-by-case basis. - Statistics:
- - Statistical significance of mutant frequencies was carried out according to the UKEMS guidelines. Thus the control log mutant frequency (LMF) was compared with the LMF from each treatment concentration, and secondly the data were checked for a linear trend in mutant frequency with test article treatment. These tests require the calculation of the heterogeneity factor to obtain a modified estimate of variance.
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Solubility: Test item was soluble in purified water at concentrations up to at least 54.30 mg/mL.
- Effects of osmolality and pH: No marked changes in osmolality or pH were observed in the Range-Finder at the highest concentration tested (5000 μg/mL) as compared to the concurrent vehicle controls.
Precipitation:
- Range-finder experiment: Following the 3 h treatment incubation period, precipitate was observed at 5000 μg/mL in the absence of S-9 only.
- Experiment 1: Following the 3 h treatment incubation period, precipitate was observed at the highest three concentrations tested in the absence of S-9 (4000 to 5000 μg/mL) and at the highest two concentrations tested in the presence of S-9 (4500 and 5000 μg/mL).
RANGE-FINDING/SCREENING STUDIES:
- Six concentrations were tested, in the absence and presence of S9, ranging from 156.3 to 5000 μg/mL.
- Highest concentration analysed was 5000 μg/mL, which gave 15 % and 76 % RS in the absence and presence of S-9, respectively.
COMPARISON WITH HISTORICAL CONTROL DATA:
- Results were compared with the historical data of the laboratory.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In Experiment 1 ten concentrations, ranging from 500 to 5000 μg/mL, were tested in the absence and presence of S-9. Seven days after treatment the highest concentrations analysed for viability and 6TG resistance were limited by post-treatment precipitate to 4000 μg/mL in the absence of S-9 and 4500 μg/mL in the presence of S-9, which gave 30 % and 83 % RS, respectively.
- In Experiment 2 ten concentrations, ranging from 500 to 5000 μg/mL, were tested in the absence and presence of S-9. Seven days after treatment the highest concentration analysed for viability and 6TG resistance was 5000 μg/mL in the absence and presence of S-9, which gave 18 % and 86 % RS, respectively. - Remarks on result:
- other: other: L5178Y tk +/- (3.7.2C) mouse lymphoma cells
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See the attached document for information on tables of results
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions, MEXORYL SCK is not considered as mutagenic at the hprt locus of L5178Y mouse lymphoma cells according to the Annex VI of the Directive 67/548/EEC and the Regulation (EC) N° 1272-2008 (CLP). - Executive summary:
In an in vitro mammalian cell gene mutation test performed according to OECD Guideline 476 and in compliance with GLP, mouse lymphoma L5178Y tk+/- cells were exposed to MEXORYL SCK dissolved in purified water in RPMI 1640 medium for 3 h, with and without metabolic activation (2 % S9 fraction of male Sprague Dawley rats liver induced with Aroclor 1254), at the following concentrations:
Range-finder experiment:
- With and without S9 mix: 156.3, 312.5, 625, 1250, 2500 and 5000 μg/mL
Main study:
- Experiment 1: 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000, 4500 and 5000 μg/mL, with and without S9 mix
- Experiment 2: 500, 1000, 2000, 2500, 3000, 3500, 3750, 4000, 4500 and 5000 μg/mL, with and without S9 mix
In the cytotoxicity study, the highest concentration analysed was 5000 μg/mL, which gave 15 % and 76 % RS in the absence and presence of S-9, respectively. In experiment 1, the highest concentrations analysed for viability and 6TG resistance were limited by post-treatment precipitate to 4000 μg/mL in the absence of S-9 and 4500 μg/mL in the presence of S-9, which gave 30 % and 83 % RS, respectively. In experiment 2, the highest concentration analysed for viability and 6TG resistance was 5000 μg/mL in the absence and presence of S-9, which gave 18 % and 86 % RS, respectively.
In Experiment 1 in the absence and presence of S-9 and Experiment 2 in the presence of S-9 no statistically significant increases in mutant frequency were observed following treatment with R0069579A at any concentration tested and there were no significant linear trends. In Experiment 2 in the absence of S-9, a statistically significant increase in mutant frequency was observed at a single concentration (4500 μg/mL) and there was a weak (but statistically significant) linear trend (p < 0.05). However, the mutant frequency value at this concentration was 4.86 mutants/106 viable cells, which was within the range of historical control data. This increase was therefore considered sufficiently small in magnitude to be of no biological relevance.Mutant frequencies in negative control cultures fell within acceptable ranges and clear increases in mutation were induced by the positive control chemicals [4-nitroquinoline 1-oxide at 0.10 or 0.15 µg/mL (without S9 mix) and benzo(a)pyrene at 2 or 3 µg/mL (with S9 mix)] indicating the validity of the study.
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