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EC number: 215-649-7 | CAS number: 1336-80-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22. Oct. 2019 (Study Plan dated); 29. Oct. 2019 (Experimental Starting Date); 15. Nov. 2019 (Experimental Completion Date)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
- Reference Type:
- publication
- Title:
- The Ames Salmonella/microsome mutagenicity assay
- Author:
- K. Mortelmans, E. Zeiger
- Year:
- 2 000
- Bibliographic source:
- K. Mortelmans, E. Zeiger (2000), The Ames Salmonella/microsome mutagenicity assay, Mutation Research 455 (1-2), 29-60, Elsevier Science B.V. DOI: 10.1016/s0027-5107(00)00064-6
- Report date:
- 2000
- Reference Type:
- publication
- Title:
- Revised methods for the Salmonella mutagenicity test
- Author:
- D.M. Maron, B.N. Ames
- Year:
- 1 983
- Bibliographic source:
- D.M. Maron, B.N. Ames (1983), Revised methods for the Salmonella mutagenicity test, Mutation Research 113 (3-4), 173-215, Elsevier Biomedical Press. DOI: 10.1016/0165-1161(83)90010-9
- Report date:
- 1983
- Reference Type:
- other: Standard Operating Procedure (SOP)
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted 21. Jul. 1997.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008, EU-Method B.13/14 adopted 30. May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ferrocholinate
- EC Number:
- 215-649-7
- EC Name:
- Ferrocholinate
- Cas Number:
- 1336-80-7
- Molecular formula:
- C11H24FeNO11
- IUPAC Name:
- 2-hydroxyethyl(trimethyl)azanium;iron(3+);2-oxidopropane-1,2,3-tricarboxylate;trihydrate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Yellow-green powder
- Purity: 12.2 % Ferric
- Homogeneity: Homogeneous
- Molecular Weight: 941.56 g/mol
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- bacteria, other: S. typhimurium TA 97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Vehicle / solvent:
- Demineralised water was used as vehicle control, prepared by LAUS GmbH, from an ion-exchanger, batch: 20190828 for the test item solutions
In a non-GLP pre-test, the solubility of the test item was tested in a concentration of 50 g/L in deminerali-zed water, dimethyl sulfoxide (DMSO) and acetone.
The solid test item is sufficiently soluble in demin. water, only.
Based on the non-GLP pre-test, demin. water was chosen as vehicle, because the test item was sufficiently soluble, and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide (DMSO)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Demineralised water
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of independent experiments: Three replicates, with/without S9, for each solvent which was used in the test, incubation for 48 hours at 37 ±1°C.
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): The titre was determined by dilution of the overnight culture using sodium chloride solution and placing 0.1 mL on maximal-soft agar. Incubation for 48 hours at 37 ±1 °C followed. It should give a density of 109 cells/mL (at the least), two replicates with and without metabolic activation.
- Test substance added in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk: Suspensions of bacterial cells are exposed to the test substance in the presence and in the absence of an exogenous metabolic activation system. In the plate incorporation method, these suspensions are mixed with an overlay agar and plated immediately onto minimal medium. In the pre-incubation method, the treatment mixture is incubated and then mixed with an overlay agar before plating onto minimal medium. For both techniques, after 2 or 3 days of incubation, revertant colonies are counted and compared to the number of spontaneous revertant colonies on solvent control plates.
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: In the pre-incubation method, the treatment mixture is incubated and then mixed with an overlay agar before plating onto minimal medium. For both techniques, after 2 or 3 days of incubation, revertant colonies are counted and compared to the number of spontaneous revertant colonies on solvent control plates.
- Number of cells spread and analysed per concentration (number of replicate cultures and total number of cells scored): 109 cells/mL, correlating to at least 100 colonies/plate after dilution.
FOR GENE MUTATION:
Five different analysable and non-toxic concentrations should be used for the evaluation of the mutagenic potential of the test item.
The colonies were counted visually and the numbers were recorded. A validated spreadsheet (attached) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control.
The mean values and standard deviations of each threefold determination were calculated as well as the increase factor of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. Additionally, the absolute number of revertants (mean revertants less mean spontaneous revertants) was given.
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Therefore, the test item is stated as not mutagenic under the conditions of this experiment.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Ferric Choline Citrate is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
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