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EC number: 220-491-7 | CAS number: 2783-94-0
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-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)
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproductive and neurobehavioral effects of Sunset Yellow FCF administered to mice in the diet
- Author:
- TOYOHITO TANAKA
- Year:
- 1 996
- Bibliographic source:
- Toxicology and industrial health,Vol 12,No.1,page no.69-79.1996
Materials and methods
- Principles of method if other than guideline:
- The reproductive effects of Sunset Yellow FCF on male and female Charles River CD rats by oral (Diet) route at different dose levels was examined.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- EC Number:
- 220-491-7
- EC Name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 2783-94-0
- Molecular formula:
- C16H12N2O7S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Details on test material:
- - Name of test material (as cited in study report):Sunset Yellow FCF or FD&C Yellow No. 6.
- Molecular formula (if other than submission substance):C16H12N2O7S2.2Na
- Molecular weight (if other than submission substance): 452.4 g/mole
- Substance type: organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Crj: CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan Inc., Kanagawa, Japan
- Age at study initiation: four weeks of age
- Weight at study initiation: Not available
- Fasting period before study: Not available
- Housing: housed individually in polycarbonate solid-floored cages with wood flakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):24 +/-1 deg c
- Humidity (%):55+/-5 deg c
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12-h light/dark cycle
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: basal diet(Nihon Clea, CE-2)
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food):Nihon Clea, CE-2 - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 5 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: no data
- Further mating after two unsuccessful attempts: [no / yes (explain)] Not available
- After successful mating each pregnant female was caged (how): individually - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- At nine weeks of age, each female was paired with one male from the same treatment group for a period of five days. The males were removed from the females after five days, and the females were allowed to carry their litters to term, and deliver and rear all of their offspring.
In the F 1 generation, litter size, litter weight, and sex ratio (male/female) were measured on postnatal day (PND) 0 (at birth). The offspring were weighed individually on PNDs 0, 4, 7,14, and 21 during the lactation period. The offspring were weaned when they were four weeks old, and one male and one female were selected randomly to continue treatment from each litter. The animals were weighed individually at four, five, six, seven, eight, and nine weeks of age after weaning.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,300,600,1200 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 0mg/kg bw (Control):10 female and 10 male mice
300 mg/kg bw (low dose group):10 female and 10 male mice
600 mg/kg bw (mid dose group):10 female and 10 male mice
1200 mg/kg bw (high dose group):10 female and 10 male mice - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: weighed individually on experimental days 0, 2, 4, 7, 14, 21, 28, and 30 during the preconception period.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
OTHER:
Movement activity of exploratory behavior: Yes - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: [yes/no]: no data
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring: F2 generation
Litter size, litter weight, and sex ratio were examined.
GROSS EXAMINATION OF DEAD PUPS: yes - Statistics:
- Food intake, litter size, litter weight, and body weight were assessed with the Bonferroni’ss multiple comparison test after the analysis of variance (ANOVA) or the Kruskal-Wallis test.
Sex ratio, survival, and behavioral developmental data were assessed with the Chi-square test (mxn) of frequency analysis. Movement activity data were assessed with the Mann-Whitney U-test of nonparametric method (Martin and Bateson, 1990). Multiple water T-maze performance data were assessed with the Sign-Wilcoxon test for trials and assessed with the Wilcoxon test within each treatment group. - Offspring viability indices:
- Yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Dam having underdeveloped mammary glands
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The average body weight of male and female mice showed no significant adverse effects from the treatment during the preconception period, and the average body weight of dams showed no significant adverse effects during the gestation or lactation periods.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The average body weight of male and female mice showed no significant adverse effects from the treatment during the preconception period, and the average body weight of dams showed no significant adverse effects during the gestation or lactation periods.
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Test substance intake: There was no significant adverse effect of Sunset Yellow FCF on the average food intake during any period
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
No significant adverse effect on movement activity of exploratory behavior in either sex at eight weeks of age.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no observed adverse effect
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- The survival indices at PND 0 showed viability indices at birth. The survivals were significantly reduced in the middle-dose group (600 mg/kg bw/day) of each sex.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant adverse effect was observed in litter weight
- Sexual maturation:
- no effects observed
- Description (incidence and severity):
- No significant adverse effect was observed in sex ratio at birth
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
No significant adverse effect was observed in litter size
Results: F2 generation
Effect levels (F2)
open allclose all
- Dose descriptor:
- LOAEL
- Generation:
- F2
- Effect level:
- 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effects: Dam having underdeveloped mammary glands.The survival indices at PND 0 showed viability indices at birth. The survivals were significantly reduced in the middle-dose group (600 mg/kg bw/day) of each sex.
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for maternal toxicity study was considered to be 300 mg/kg bw/day whereas LOAEL was considered to be 600 mg/kg bw/day in Crj: CD-1 strain mouse when Sunset Yellow FCF was administered orally by diet.
- Executive summary:
Sunset Yellow FCF was administered in the diet to 60 mice (10/sex/group) at dietary levels of 300, 600, and 1200 mg/kg bw/day the control groups (20 mice, 10/sex) were given basal diets (Nihon Clea, CE-2) to investigate for possible reproductive effect. Individual food intake of mice was measured during five divided periods - preconception (from five weeks of age to mating), mating (5 days), gestation (14 days), lactation (from birth to weaning), and F 1 generation (four to nine weeks of age).
During experiment adverse effects observed as dam having underdeveloped mammary glands. The survival indices at PND 0 showed viability indices at birth. The survivals were significantly reduced in the middle-dose group (600 mg/kg bw/day) of each sex.
And on other side the average body weight of male and female mice showed no significant adverse effects from the treatment during the preconception period, and the average body weight of dams showed no significant adverse effects during the gestation or lactation periods. No effects on food consumption, No significant adverse effect on movement activity of exploratory behavior in either sex at eight weeks of age.
Therefore, NOAEL for maternal toxicity study was considered to be 300 mg/kg bw/day whereas LOAEL was considered to be 600 mg/kg bw/day in Crj: CD-1 strain mouse when Sunset Yellow FCF was administered orally by diet.
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