Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Repeated dose toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological Evaluation Of Certain Food Additives and Contaminants
- Author:
- WHO Expert Committee on Food Additives
- Year:
- 1 969
- Bibliographic source:
- INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY, WORLD HEALTH ORGANIZATION,Series No. 46A WHO/FOOD ADD/70.36
Materials and methods
Test guideline
- 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
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): FD&C Green No. 3 - Molecular formula (if other than submission substance): C37H34N2Na2O10S3 - Molecular weight (if other than submission substance): 808.84 g/mole - Substance type: Organic - Physical state: solid
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Doses / concentrations
- 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
Examinations
- 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.
Results and discussion
Results of examinations
- 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.
Effect levels
- 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
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.