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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
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- 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
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- 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
Description of key information
Repeated Dose toxicity (Oral)
The summaries of the various studies presented as weight of evidence having Klimisch rating 2 are presented in the table below:
S. No End pointValue (mg/kg bw)SpeciesKlimisch Rating
1.NOAEL7142.85Mouse2
2.NOAEL500Dog2
3.NOAEL2500Rat2
4.NOAEL2857Mouse2
Thus, it can be seen that the no observed adverse effect level (NOAEL) values in the various chronic studies ranges from 500 to 7142.85 mg/kg bw in various animal species tested. Hence, it can be concluded that 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 (Synonym Fast Green FCF/ FD&C Green No. 3) is not likely to exhibit toxic effects, within the dose levels mentioned upon chronic repeated dosing by the oral route.
Repeated Dose (Dermal)
In a Chronic dermal toxicy Study, Swiss Webster male and female mice treated with F D & C Green No. 3, the concentration of 0 and 1.0 % twice weekly. The results shows that F D & C Green NO. 3.was not toxic dermally. No effect was observed on survival and clinical signs of treated mice. High or low body weights observed late in treated group were due to only a few surviving animals which reduced the biological significance of the averages. In addition, No significant incidence of gross changes was observed in treated mice. Malignant lymphoma of liver, Kidneys and Lungs, Myeloid metaplasia of Spleen were observed in treated mice. There was no indication of treatment related changes since most lesions were also evident in the control.
Therefore, NOAEL was considered to be 1.0 % (1428.5 mg/kg) when Swiss Webster male and female mice were treated with FD & C Green NO. 3.by dermal application for 19.5 months.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from WHO Food Additive Series
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated dose carcinogenicity
- Principles of method if other than guideline:
- Repeated dose carcinogenicity study of FD&C Green No. 3 orally in mice
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: Charles-River CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 43 days study
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- mice were fed diets containing 0, 0.5, 1.5, or 5.0% Fast Green FCF
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 24 months
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:0, 0.5, 1.5 and 5.0 % (714.3, 2143 and 7142.85 mg/kg/day respectively)Basis:nominal in diet
- No. of animals per sex per dose:
- Total : 3000 %: 60 male, 60 female 0.5 % 30 male, 30 female 1.5 % : 30 male, 30 female 5.01 % : 30 male, 30 female
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule: No data available- Cage side observations checked in table [No.?] were included: Mortality and morbidity was observedDETAILED CLINICAL OBSERVATIONS: No data available - Time schedule: No data availableBODY WEIGHT: Yes - Time schedule for examinations: No data available FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available FOOD EFFICIENCY: No data available- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available - Time schedule for examinations: No data available OPHTHALMOSCOPIC EXAMINATION: No data available - Time schedule for examinations: No data available- Dose groups that were examined: No data available HAEMATOLOGY: Yes - Time schedule for collection of blood: At 3, 6, 12, 18 months and on completion of study.- Anaesthetic used for blood collection: No data available - Animals fasted: No data available - How many animals: 10 animals from each group at 3, 6, 12, 18 months and all on completion of study. - Parameters checked in table [No.?] were examined: Haemoglobin, haematocrit, and erythrocyte counts were examined. CLINICAL CHEMISTRY: No data available- Time schedule for collection of blood:- Animals fasted: No data available- How many animals: No data available- Parameters checked in table [No.?] were examined: No data available URINALYSIS: No data available- Time schedule for collection of urine: No data available- Metabolism cages used for collection of urine: No data available - Animals fasted: No data available- Parameters checked in table [No.?] were examined: No data available NEUROBEHAVIOURAL EXAMINATION: No data available - Time schedule for examinations: No data available- Dose groups that were examined: No data available- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data availableOTHER: No data available
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes Gross changes/tissue masses were examined for all animals in treated dose groups. HISTOPATHOLOGY: Yes Tissues were examined histologically from all control and 5% dose groups as well as all animals dying or killed in extremis from these groups Organ examined: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 were examined.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No mertality were observed in treated male and female mice as compare to control.
- Mortality:
- no mortality observed
- Description (incidence):
- No mertality were observed in treated male and female mice as compare to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 5 % in male mice mean body weight was significantly decreased at weeks 52 and 78 as compare to control. In female mice mean body weight was consistently decreased as compare to control.
- 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
- Description (incidence and severity):
- When treated with 5% in male mice slight reductions in haemoglobin, haematocrit, and erythrocyte counts were observed at 18 months but no other consistent or dose-related haematological changes were observed.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- -Clinical signs and mortalityMortality : No mertality were observed in treated male and female mice as compare to control.Clinical sign: No data available -Body weight and weight gain: When treated with 5 % in male mice mean body weight was significantly decreased at weeks 52 and 78 as compare to control.In female mice mean body weight was consistently decreased as compare to control.-Haematology:When treated with 5% in male mice slight reductions in haemoglobin, haematocrit, and erythrocyte counts were observed at 18 months but no other consistent or dose-related haematological changes were observed.-Histopathology: Histological examination did not reveal any treatment-related lesions and the incidence, origins and histology of benign and malignant neoplasms did not differ significantly between controls and treated animals.
- Dose descriptor:
- NOAEL
- Effect level:
- 7 142.85 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effect on survival, body weight, hematology, gross pathology and histopathology
- Critical effects observed:
- not specified
- Conclusions:
- NOAEL for repeated dose toxicity study was considered to be 5% (7142.85 mg/kg/day) in male and female mice when exposed to FD&C Green No. 3 by oral route for 24 months.
- Executive summary:
A Chronic study was conducted to evaluate the toxic effects of repeated administration of FD&C Green No. 3 to male and female mice by feed. FD&C Green No. 3 was administered to mice in diet at dosages of 0, 0.5, 1.5 and 5.0 % (714.3, 2143 and 7142.85 mg/kg/day) for 24 months. No mortalities occurred that could be directly attributed to treatment. Change was observed in body weight of male and female mice at 5 % but no other consistent differences in body weight were noted. Similarly, no changes were observed in hematology of female mice, in male mice change was observed in haemoglobin, haematocrit, and erythrocyte counts at 18 months but no other consistent or dose-related haematological changes were observed. In addition, no change were observed in histopathology of treated male and female mice when compare with control. Therefore, NOAEL for repeated dose toxicity study was considered to be 5% (7142.85 mg/kg/day) in male and female mice when exposed toFD&C Green No. 3by oral route for 24 months.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 7 142.85 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- weight of evidence approach from studies published in peer reviewed journals
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: dermal
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: Skin painting studies
- Principles of method if other than guideline:
- Skin painting studies in Swiss Webster mice were carried out.
- GLP compliance:
- not specified
- Limit test:
- yes
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source:- Age at study initiation:- Weight at study initiation: 17 to 25 g- Fasting period before study: No data available- Housing: All groups were equally divided as to sex. Mice of the same sex were housed five per cage.- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum- Water (e.g. ad libitum): Fresh- 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
- Type of coverage:
- not specified
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on exposure:
- TEST SITE- Area of exposure: dorsal area- % coverage: 6 cm2- Type of wrap if used: No data available- Time intervals for shavings or clipplings: according to the rate of hair growth.REMOVAL OF TEST SUBSTANCE- Washing (if done): No data available- Time after start of exposure: No data availableTEST MATERIAL- Amount(s) applied (volume or weight with unit): No data available- Concentration (if solution):0.1 ml - Constant volume or concentration used: yes- For solids, paste formed: Not applicableVEHICLE- Justification for use and choice of vehicle (if other than water): Distilled water was used- Amount(s) applied (volume or weight with unit): No data available- Concentration (if solution): No data available- Lot/batch no. (if required): No data available- Purity: No data availableUSE OF RESTRAINERS FOR PREVENTING INGESTION: No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 19.5 months
- Frequency of treatment:
- Twice weekly
- Remarks:
- Doses / Concentrations:1.0 % (1428.5 mg/kg)Basis:no data
- No. of animals per sex per dose:
- Total: 300 0 % : 100 male, 100 female1.0 % : 50 male, 50 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 50 mice/ sex/dose were used and 0.1 ml of the test material was applied to the dorsal of each mouse with rubber applicator.Animals that died, those sacrificed moribund and those surviving the 19.5 month experimental period were necropsied and tissues were preserved in 10% formalin.
- Positive control:
- No data available
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule: Daily - Cage side observations checked in table [No.?] were included: Observations were done to record mortality DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: Daily DERMAL IRRITATION (if dermal study): No data BODY WEIGHT: Yes, Time schedule for examinations: Daily FOOD CONSUMPTION:- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data availableFOOD EFFICIENCY:- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data availableWATER CONSUMPTION: No data OPHTHALMOSCOPIC EXAMINATION: No data availableHAEMATOLOGY: No data availableCLINICAL CHEMISTRY: No data available URINALYSIS: No data availableNEUROBEHAVIOURAL EXAMINATION: No data availableOTHER: No data available
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes Grossly abnormal organs or tissues were observed. HISTOPATHOLOGY: YesOrgans were fixed in 10% formalin solution.Tissues examined.Brain, Pituitary, Thyroid, Thymus, Liver, Spleen, Kidney, Adrenal, Stomach, Small intestines, Large intestines, Urinary bladder, Axillary lymph node, Kidney, ovary, Skin from area of treatment, Any tissue masses and grossly abnormal organs or tissues were examined.
- Other examinations:
- No data available
- Statistics:
- No data available
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related effect were observed on survival of mice as compared to control. No effect was observed on behavior of treated mice as compared to control.
- Dermal irritation:
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No treatment related effect were observed on survival of mice as compared to control. No effect was observed on behavior of treated mice as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- High or low body weights observed late in treated group were due to only a few surviving animals which reduced the biological significance of the averages.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant incidence of gross changes was observed in treated mice as compared to control.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Malignant lymphoma of liver, Kidneys and Lungs, Myeloid metaplasia of Spleen were observed in treated mice. There was no indication of treatment related changes since most lesions were also evident in the controls.
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- The findings described appear to indicate freedom from significant systemic and/or dermal toxic manifestations associated with administrations.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 428.5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Survival, Clinical signs, Body weight, Gross pathology and histopathology
- Critical effects observed:
- not specified
- Conclusions:
- NOAEL was considered to be 1.0 % (1428.5 mg/kg) when Swiss Webster male and female mice were treated with F D & C Green NO. 3.
- Executive summary:
- In a Chronic dermal toxicy Study, Swiss Webster male and female mice treated with F D & C Green No. 3, the concentration of 0 and 1.0 % twice weekly. The results shows that F D & C Green NO. 3.was not toxic dermally. No effect was observed on survival and clinical signs of treated mice. High or low body weights observed late in treated group were due to only a few surviving animals which reduced the biological significance of the averages. In addition, No significant incidence of gross changes was observed in treated mice. Malignant lymphoma of liver, Kidneys and Lungs, Myeloid metaplasia of Spleen were observed in treated mice. There was no indication of treatment related changes since most lesions were also evident in the control.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 428.5 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Reliable with restriction
Additional information
Repeated dose toxicity (Oral)
The summaries of the various studies presented as weight of evidence having Klimisch rating 2 are presented in the table below:
S. No | End point | Value (mg/kg bw) | Species | Klimisch Rating |
1. | NOAEL | 7142.85 | Mouse | 2 |
2. | NOAEL | 500 | Dog | 2 |
3. | NOAEL | 2500 | Rat | 2 |
4. | NOAEL | 2857 | Mouse | 2 |
Thus, it can be seen that the no observed adverse effect level (NOAEL) values in the various chronic studies ranges from 500 to 7142.85 mg/kg bw in various animal species tested. Hence, it can be concluded that 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 (Synonym Fast Green FCF/ FD&C Green No. 3) is not likely to exhibit toxic effects, within the dose levels mentioned upon chronic repeated dosing by the oral route.
Repeated Dose Toxicity (Dermal)
In a Chronic dermal toxicy Study, Swiss Webster male and female mice treated withF D & C Green No. 3, the concentration of 0 and 1.0 % twice weekly. The results shows that F D & C Green NO. 3.was not toxic dermally. No effect was observed on survival and clinical signs of treated mice. High or low body weights observed late in treated group were due to only a few surviving animals which reduced the biological significance of the averages. In addition, No significant incidence of gross changes was observed in treated mice. Malignant lymphoma of liver, Kidneys and Lungs, Myeloid metaplasia of Spleen were observed in treated mice. There was no indication of treatment related changes since most lesions were also evident in the control.
Therefore, NOAEL was considered to be 1.0 % (1428.5 mg/kg) when Swiss Webster male and female mice were treated with FD & C Green NO. 3.by dermal application for 19.5 months.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Data is from an authoritative source and is part of weight of evidence studies.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
This end point was considered for waiver since repeated exposure of humans via inhalation to the chemical FD&C Green is highly unlikely taking into account the extremely low vapour pressure of 1.7E-43 mm Hg at 25 deg C. In addition, the possibility of exposure to inhalable particles is also negligible given the particle size distribution of the chemical which have larger particle size than which can be inhaled. Thus, repeated exposure by the inhlation route for this chemical appears highly unlikely.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
data is from peer reviewed journal
Justification for classification or non-classification
From the available data on chronic repeated dose studies of the chemical FD&C Green No. 3, by the oral and dermal route of exposure, it can be concluded that based upon the high no observed adverse effect level (NOAEL) values, the chemical is not likely to exhibit toxic effects on repeated exposure within the dose levels mentioned in the studies. Exposure by the inhalation route for this chemical is also unlikely given the low vapour presure of the chemical.
Thus, the chemical is not likely to be classified for repeated dose toxicity by the oral, inhalation and dermal route of exposure.
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