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EC number: 219-091-5 | CAS number: 2353-45-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: Cytokinesis Block Micronucleus (CBMN) Assay) was performed for Fast green FCF using lymphocytes isolated from human volunteers.
- Principles of method if other than guideline:
- Cytokinesis Block Micronucleus (CBMN) Assay) was performed for Fast green FCF using lymphocytes isolated from human volunteers.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- Human Lymphocytes
- Species / strain / cell type:
- other: Human
- Details on mammalian cell type (if applicable):
- - Type and identity of media: No data available- Properly maintained: No data available- Periodically checked for Mycoplasma contamination: No data available- Periodically checked for karyotype stability: No data available- Periodically "cleansed" against high spontaneous background: No data available
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- 100, 200 and 500 μg mL-1
- Vehicle / solvent:
- water
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in mediumBlood samples from healthy young adult volunteer without any history of chronic illness, drug intake and or any life style associated bad habits were collected with informed consent. Lymphocytes were separated from these samples using Lymphoprep. Four parallel Lymphocyte micro cultures in duplicate were set up for each sample to evaluate the extent of genotoxicity. Culture A was kept as control and coloring agents were added to Culture B, C and D with varying concentrations of 100, 200 and 500 μg mL-1, Cytochalasin B (Sigma) at a concentration of 4.5 μg mL-1 was added to all the 4 cultures at 44th hour to block the cell division at Cytokinesis. The cultures were harvested at 72nd hour; slides were prepared and stained with 10% Giemsa stain. Observed under a plan achromatic microscope for enumerating the frequency of micronuclei among 1000 binucleated cells and recorded.DURATION- Preincubation period: No data available- Exposure duration: 72 hrs- Expression time (cells in growth medium): No data available- Selection time (if incubation with a selection agent): No data available- Fixation time (start of exposure up to fixation or harvest of cells):SELECTION AGENT (mutation assays): Giemsa stainSPINDLE INHIBITOR : Cytochalasin BSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: 1000 binucleated cells examinedDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No data availableOTHER EXAMINATIONS:- Determination of polyploidy: No data available- Determination of endoreplication: No data available- Other: No data availableOTHER: No data available
- Evaluation criteria:
- The criteria for enumeration were: (1) cells should have two nuclei of approximately equal size, (2)the 2 nuclei may be attached by a fine nucleoplasmic bridge, (3) the two nuclei may overlap slightly or toucheach other at the edges and (4) Cells should not contain more than 6 micronuclei.
- Statistics:
- Statistical Package for Social Sciences (SPSS).
- Species / strain:
- other: Human
- Metabolic activation:
- not specified
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: other: Human lymphocytes
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):positiveFast green FCF is found to induce gene mutation in the lymphocytes isolated from human volunteers in the Cytokinesis Block Micronucleus (CBMN) Assay performed.
- Executive summary:
Cytokinesis Block Micronucleus (CBMN) Assay was performed for the test chemicalFast green FCF using lymphocytes isolated from human volunteers.
Blood samples from healthy young adult volunteer without any history of chronic illness, drug intake or any life style associated bad habits were collected. Lymphocytes were separated from the samples.Four parallel Lymphocyte micro cultures in duplicate were set up for each sample to evaluate the extent of genotoxicity. Culture A was kept as control and coloring agents were added to Culture B, C and D with varying concentrations of 100, 200 and 500 μg mL-1,Cytochalasin B was added to all the 4 cultures at 44th hour to block the cell division at Cytokinesis.The cultures were harvested at 72nd hour; slides were prepared and stained with 10% Giemsa stain. Observed under a plan achromatic microscope for enumerating the frequency of micronuclei among 1000 binucleated cells and recorded.
The criteria for enumeration were:
(1) cells should have two nuclei of approximately equal size,
(2)the 2 nuclei may be attached by a fine nucleoplasmic bridge,
(3) the two nuclei may overlap slightly or touch
each other at the edges and
(4) Cells should not contain more than 6 micronuclei.
Fast green FCF is found to induce gene mutation in the lymphocytes isolated from human volunteers in theCytokinesis Block Micronucleus (CBMN) Assay performed.
According to the publication, the test material Fast Green FCF is a positive mutagen.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
Genetic toxicity In vitro
Studies of Fast Green FCF were reviewed for genetic toxicity in vitro from reliable sources having Klimisch rating 2
The summary of the results are presented below:
Sr. No | Type of genotoxicity | Result | Species | Remarks |
1. | Gene mutation | Positive | S. typhimurium TA 100 | Experimental data for target chemical |
2. | Chromosome aberration
| Positive | Chinese hamster lung fibroblasts (V79) | Experimental data for target chemical |
3. | Gene mutation | Negative | Embryo cells isolated from Fischer rat | Experimental data for target chemical |
4. | Gene mutation | Negative | Bacillus subtilis/: H17(rec+)and M45(Rec-) | Experimental data for target chemical |
5. | Gene mutation | Negative | Diploid Yeast cells/ BZ 34 | Experimental data for target chemical |
6. | Chromosome aberration
| Positive | Human lymphocytes | Experimental data for target chemical |
7. | Gene mutation | Negative | Salmonella typhimurium | Experimental data for target chemical |
On the basis of studies summarised in the above table, it can be observed that the substance gives positive as well as negative results for genetic toxicity. Genetic toxicity In vivo
Studies of Fast Green FCF were reviewed for genetic toxicity in vivo from reliable sources having Klimisch rating 2
The summary of the results are presented below:
Sr. No | Type of genotoxicity | Result | Species | Remarks |
1. | DNA damage and/or repair | Positive | Mouse | Experimental data for target chemical |
2. | DNA damage and/or repair | Negative | Rat | Experimental data for target chemical |
3. | Chromosome aberration
| Positive | Mouse | Experimental data for target chemical |
4. | DNA damage and/or repair | Negative | Rat | Experimental data for target chemical |
On the basis of studies summarised in the above table, it can be observed that the substance gives positive results for genetictoxicity in mice whereas it gives negative results in rats
Justification for selection of genetic toxicity endpoint
Data is from peer reviewed journal and from a recent study (2011) done on human lymphocytes.
Justification for classification or non-classification
Based on the available data and adopting a weight of evidence approach, the chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl) amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt is shown to exhibit genetic toxicity to the various Salmonella strains of bacteria as well as chromosomal abberation in Chinese hamster lung fibroblasts. Thus, the chemical is likely to be classified as Mutagen category 2 based upon the mutagenic effects observed in animals.
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