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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Sister chromatid exchange induced by secondary and tertiary amine containing dyes and in combination with nitrite in vivo in mice
- Author:
- A.K. Giri and A. Mukherjee
- Year:
- 1 990
- Bibliographic source:
- Cancer Letters, 52 (1990) 33-37
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Data is from Journal with permission
- Principles of method if other than guideline:
- Genetic toxicity in vivo test was performed on Swiss albino mice using sister chromatid exchange(SCE) by Fast green FCF.
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay
Test material
- Reference substance name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- EC Number:
- 219-091-5
- EC Name:
- Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt
- Cas Number:
- 2353-45-9
- Molecular formula:
- C37H36N2O10S3.2Na
- IUPAC Name:
- disodium 2-({4-[ethyl(3-sulfonatobenzyl)amino]phenyl}{4-[ethyl(3-sulfonatobenzyl)iminio]cyclohexa-2,5-dien-1-ylidene}methyl)-5-hydroxybenzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Fast Green FCF (2353-45-9)- Molecular formula (if other than submission substance): C37-H36-N2-O10-S3.2Na- Molecular weight (if other than submission substance): 808.8576 g/mol- Substance type: Organic- Physical state: Solid- Purity: No data available - Impurities (identity and concentrations): No data available
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Swiss albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Details on test animals and env conditionsTEST ANIMALS- Source: Laboratory bred- Age at study initiation: 12 weeks old- Weight at study initiation: 30 g- Assigned to test groups randomly: No data available- Fasting period before study: No data available- Housing: housed in batches of five inpolycarbonate cages with bedding of ricehusks.- Diet (e.g. ad libitum): food pellets (Lipton India Ltd.) ad libitum.- Water (e.g. ad libitum): ad libitum.- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used :Distilled water- Justification for choice of solvent/vehicle: No data available- Concentration of test material in vehicle: No data available- Amount of vehicle (if gavage or dermal): No data available- Type and concentration of dispersant aid (if powder): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Details on exposure:
- No data available
- Duration of treatment / exposure:
- No data available
- Frequency of treatment:
- Ones
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:5, 10, 25, 50 and 100 mg/kg body weightBasis:actual ingested
- No. of animals per sex per dose:
- 5/dose
- Control animals:
- not specified
- Positive control(s):
- Positive controls: mitomycin-C - Justification for choice of positive control(s): No data available- Route of administration: No data available- Doses / concentrations: 2.5 mg/kg body weight
Examinations
- Tissues and cell types examined:
- Bone marrow cell
- Details of tissue and slide preparation:
- Details of tissue and slide preparationCRITERIA FOR DOSE SELECTION: No data available TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): No data availableDETAILS OF SLIDE PREPARATION: Differential staining of SCE was carried out by a modification of the fluorescence plus Giemsa (FPG) technique. The slides were coded and 20 second generation metaphase cells per dose (only those with 40 chromosomes) were scored from each animal.
- Evaluation criteria:
- sister chromatid exchanges/cell
- Statistics:
- For all statistical analyses, the level of significance was established at an alpha of 0.05. A one-tailed Cochran-Armitage trend test was used to determine if a treatment-related increase occurred for SCE data. In addition, pairwise comparisons between each treatedgroup and the negative control group were conducted using the t-test with the alpha level Bonferroni-corrected for multiple comparisons to determine the minimal effective dose for SCE induction. Duncan’s multiple range test was carried out following ANOVA for comparison between the dyes (individually) and dye plus nitrite treated groups. Selection of dose was based on our earlier studies and that on the guidelines of WHO. The doses of IC and of FGFCF were reduced by 50% when the dyes were tested in combination with sodium nitrite to detect whether there was any synergistic effect or not.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positiveThe genetic toxicity for Fast Green FCF (2353-45-9) was found to be positive in Swiss albino male mice.
- Executive summary:
Gene toxicity in vitro study was performed for the test chemical Fast Green FCF in Swiss Albino male mice.
Under anaesthesic condition each mouse was implanted subcutaneously in the neck with a 50-mg tablet of 5-bromodeoxyuridine (BrDU) prior to treatment with chemicals. Fast Green FCF were dissolved in distilled water and were given separately to mice as a single i.p. injection at different concentration of 5, 10, 25, 50 and 100mg/kg body weight one hour after BrdU tablet implantation. The positive control is mitomycin-C (2.5mg/kg body weight) and negative control is distilled water were injected separately to other mice. After 24 hours the mice were killed by cervical dislocation and differential staining of sister chromatid exchange was carried out. The slides were coded and 20 second generation metaphase cells per dose (only those with 40 chromosomes) were scored from each animal.
From the study it was found that 10 mg of FGFCF induced a significantly higher number of SCEs/cell than the negative control.These concentrations were the minimum effective dose for the chemicals.
So from the above study it was concluded that Fast Green FCF (2353-45-9) was found to be positive for genetic toxicity test to Swiss albino mice.
According to the publication, the test material is a positive gene mutant.
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