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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
Carcinogenicity
Administrative data
Description of key information
From the data available on the carcinogenecity of Fast Green FCF (chemical name: dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt) & using the weight of evidence appraoch, it can be concluded that the chemical is not likely to be carcinogenic within the dose levels mentioned in the studies since the tumors and adenomas were not attributed to the test chemical and were not differnt from those observed in the control. Hence, it is concluded that the chemical is not likely to be carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- 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 authoritative source of scientific information
- Qualifier:
- according to guideline
- Guideline:
- other: Carcinogenicity test was performed on male and female Charles-River CD-1 mice treated with fast green FCF with different concentrations.
- Principles of method if other than guideline:
- Fast Green FCF was studied in a carcinogenicity study to evaluate its toxic nature in mice
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- other: Charles-River CD-1
- Sex:
- male/female
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Diet
- Details on exposure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 Yrs
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:0, 0.5, 1.5, or 5.0% (0,714.28,2142.85,7142.857 mg/kg/day)Basis:nominal in diet
- No. of animals per sex per dose:
- 60 animals/sex/dose
- Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: YesHAEMATOLOGY: Yes - Time schedule for collection of blood: No data available- Anaesthetic used for blood collection: 3, 6, 12, and 18 months- Animals fasted: No data- How many animals: Ten animals/sex/group- Parameters examined. Haemoglobin, haematocrit, and erythrocyte counts were measured.
- Sacrifice and pathology:
- GROSS PATHOLOGY:Yes, gross changes/tissue masses were examined.HISTOPATHOLOGY: Yes, The following tissues were examined histologically from all survivors from the control and 5%-dose groups as well as all animals dying or killed in extremis from these groups: adrenals, aorta, bone and marrow (femur), brain (3 sections), eyes (with optic nerve), gall bladder, gastrointestinal tract (oesophagus, stomach, duodenum, ileum, caecum, colon), heart, kidneys, liver, lung, lymph nodes (mesenteric and mediastinal), mammary gland, nerve (sciatic), ovaries, pancreas, pituitary, prostate, salivary gland, seminal vesicles, skeletal muscle, skin, spinal cord, spleen, testes with epididymides, thymus, thyroid/parathyroid, trachea, urinary bladder, uterus, and gross lesions/tissue masses. In addition, gross changes/tissue masses were examined histologically from all animals in the lower-dose groups.
- Other examinations:
- No data available
- Statistics:
- No data available
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- No treatment related neoplasm observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No dose related effect on mortality of animals was notedBODY WEIGHT AND WEIGHT GAIN: Body weight of 5%-dose group female was lower than control and the mean body weight for male 5%-dose group was lower than controls at weeks 52 and 78.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):No data availableFOOD EFFICIENCY: No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data availableOPHTHALMOSCOPIC EXAMINATION: No data availableHAEMATOLOGYNo dose related effects was observed but slight reduction in haemoglobin, haematocrit, and erythrocyte counts were observedCLINICAL CHEMISTRY: No data availableURINALYSIS: No data availableNEUROBEHAVIOUR: No data availableORGAN WEIGHTS: No data availableGROSS PATHOLOGY: YesHISTOPATHOLOGY: NON-NEOPLASTIC: No data availableHISTOPATHOLOGY: NEOPLASTIC (if applicable): No treatment related lesions were observed, benign and malignant neoplasms did not differ significantly between controls and treated animals
- Relevance of carcinogenic effects / potential:
- No treatment related lesions were observed, benign and malignant neoplasms did not differ significantly between controls and treated animals. Thus, Fast green FCF (2353-45-9) is found to be non-carcinogenic with a No Observed Adverse Effect level at 7142.857 mg/kg/day in male/female Charles CD-1 mice.
- Dose descriptor:
- NOAEL
- Effect level:
- 7 142.857 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- The Carcinogenic Low Observed adverse effect level (LOAEL) for the test compound Fast Green FCF is 625 mg/kg bw in male and female Charles Albino rats.
- Executive summary:
- Carcinogenicity test was performed on male and female Charles-River CD-1 mice mice by a daily intake of at 0,714.28, 2142.85, 7142.857 mg/kg/day concentrations for 2 years. All animals dying or killed in a moribund condition and organ histopathology was observed for all animals. No treatment-related effects on mortality were observed. No dose-related haematological changes were observed and no dose related a benign and malignant neoplasm was observed in treated animals.
Fast green FCF (2353-45-9) is found to be non-carcinogenic with a No Observed Adverse Effect level at 7142.857 mg/kg/day in male/female Charles CD-1 mice.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 7 142.857 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Weight of evidence using data is from peer reviewed journals and authoritative source of scientific information
Justification for classification or non-classification
The chemical is not likely to be carcinogenic within the dose levels mentioned in the studies since the tumors and adenomas were not attributed to the test chemical and were not differnt from those observed in the control. Hence, based upon the weight of evidence approach it is concluded that the chemical is not likely to be carcinogenic.
Additional information
Studies of Fast Green FCF were reviewed for carcinogenicity from reliable sources having Klimisch rating 2
The summary of the weight of evidence studies is furnished below
Sr. No | End Point | Value | Species | Route | Effects | Remarks |
1. | LOAEL | 625 mg/kg bw | Rat | Oral : feed |
Observation made indicate an increased incidence of urothelial hyperplasia in treated males and of urinary bladder transitional cell/urothelial neoplasms in males of the 5%-dose group
|
Experimental data for target chemical
|
2. | NOEL | 1 mg/kg bw |
Hamster
|
Subcutaneously (SC) or intraperitoneally
|
No effect
| Experimental data for target chemical
|
3. | NOAEL | 7142.857 mg/kg bw | Mouse | Oral : feed |
No effect
| Experimental data for target chemical
|
4. | NOAEL | 2500 mg/kg bw | Rat | Oral : Unspecified |
No effect
| Experimental data for target chemical
|
Thus, it can be concluded that the chemical is not likely to be carcinogenic within the dose levels mentioned in the studies since the tumors and adenomas were not attributed to the test chemical and were not differnt from those observed in the control. Hence, it is concluded that the chemical is not likely to be carcinogenic.
Justification for selection of carcinogenicity via oral route endpoint:
Data is from authoritative source of scientific information
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