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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological Evaluation Of Certain Food Additives and Contaminants
- Author:
- WHO (WHO Food Additive Series 20)
- Year:
- 1 987
- Bibliographic source:
- WHO Food Additive Series 20-1987 submitted by Certified Color Manufacturers' Association
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- method details not mentioned in the publication
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Fast Green FCF- Substance type: Organic- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on mating procedure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 weeks before the first mating and dosing continued throughout the gestation, lactation, and post-weaning phases for three successive generations.
- Frequency of treatment:
- Daily
- Details on study schedule:
- The F0 generation rats were mated twice. The F0 generation rats were mated twice, the F1a litters being necropsied and F1b litters were used for breeding. Animals from the F1b generation were mated 3 times and the offspring of the F2a and F2b generations were treated identically to the F1a and F1b generations.In third mating half of the pregnant dams were sacrificed on day 19 of gestation and other half were allowed to deliver normally (F2c) and sacrificed at weaning. The F2b animals were mated once and allowed to raise their offspring to weaning.
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 10, 100, 300, or 1,000 mg/kg b.w./dayBasis:nominal in diet
- No. of animals per sex per dose:
- Total :1500 mg/kg bw/day: 10 male, 20 female 10 mg/kg bw/day: 10 male, 20 female100 mg/kg bw/day: 10 male, 20 female300 mg/kg bw/day: 10 male, 20 female1000 mg/kg bw/day: 10 male, 20 female
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinationsCAGE SIDE OBSERVATIONS: Yes - Time schedule: No data available- Cage side observations checked in table [No.?] were included.: Observations were also done to record any adult mortality.
- Litter observations:
- Survival, weights and sex were observed
- Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)SACRIFICEThe F1a and F2c litters being necropsied at weaning.F1a and F1b, Following the third mating, half of the pregnant dams were sacrificed on day 19 of gestation.The F2b animals were mated once and allowed to raise their offspring to weaning when both parents and offspring were culled.GROSS NECROPSY- Gross necropsies were performed on F1a, F2a, and F2c
- Postmortem examinations (offspring):
- SACRIFICEF3a generation at weaning was fixed at necropsy.GROSS NECROPSY- Gross necropsies were performed on F3a offspring at weaning. HISTOPATHOLOGY were performed on all parent animals. Selected tissues from 5 animals of each sex/dose from the F1b parents were fixed at necropsy and tissues examined histologically from the control group and high-dose group.Organ examined: Stomach, ileum, jejunum, colon, liver, spleen, heart, lungs, adrenals, kidneys, urinary bladder, thyroid, ovaries, and uterus or testes were examined. Total embryos/resorption sites, and the corpora lutea per ovary were recorded
- Reproductive indices:
- Mating performance, pregnancy and fertility rates, gestation length and resorption rates were examined.
- Offspring viability indices:
- Yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Mortality: No effect were observed on survival of treated rat as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect were observed on body weight of treated rat as compared to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect were observed on body weight of treated rat as compared to control.
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No macroscopic or microscopic tissue abnormalities were observed in treated rat as compared to control.
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects were observed on survival, food consumption, body weight, mating performance, pregnancy and fertility rates, gestation length, offspring survival, weights and sex, litter survival, resorption rates, gross pathology and histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects were observed on food consumption, body weight, adult mortality, offspring survival, weights and sex, litter survival, gross pathology and histopathology
- Remarks on result:
- other: Generation: F3 (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect were observed on offspring survival of treated rat as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect were observed on offspring body weight of treated rat as compared to control
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross pathological changes were observed in treated offspring.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- No macroscopic or microscopic tissue abnormalities were observed in treated offspring as compared to control
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects were observed on survival, food consumption, body weight, mating performance, pregnancy and fertility rates, gestation length, offspring survival, weights and sex, litter survival, resorption rates, gross pathology and histopathology
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg body weight /day when Long-Evans male and female rat treated with Fast Green FCF.
- Executive summary:
In a 3-generation reproductive toxicity study,Long-Evans male and female rat treated with Fast Green FCF in the concentration of 0, 10, 100, 300 and 1,000 mg/kg b.w. /day orally in diet. No effect were observed onsurvival, food consumption and body weight of F1, F2 and F3 generation treated male and female rat. Similarly, no effect were observed on mating performance, pregnancy and fertility rates, gestation length, offspring survival, weights and sex, litter survival and resorption rates of F1, F2 and F3 generation treated male and female rat. In addition,No gross pathological changes and macroscopic or microscopic tissue abnormalitieswere observed inF1, F2 and F3 generation treated male and female rat.
Therefore,NOAEL was considered to be1000 mg/kg body weight /daywhen Long-Evans male and female rat treated with Fast Green FCF orally in diet.
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