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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
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)
Data source
Reference
- Reference Type:
- publication
- Title:
- LONG-TERM TOXICITY OF SUNSET YELLOW FCF IN MICE
- Author:
- I. F. GAUNT and P. L. MASON P. GRASSO and IDA S. Kiss
- Year:
- 1 974
- Bibliographic source:
- Food and Cosmetic toxicology, Vol. 12, pp. 1-10, 1974.
Materials and methods
- Principles of method if other than guideline:
- 80 weeks chronic repeated dose oral toxicity study of Sunset Yellow examination in Mice of the Charles River CD strain to evaluate adverse effects and their reversibility and the non observed- effect level.
- 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: Sunset Yellow FCF
- Molecular formula: C16H12N2O7S2.2Na
- Molecular weight: 454.38
- Substance type: organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding colony
- Weight at study initiation: Male- 21-30 g and female - 17-25 g
- Fasting period before study: no
- Housing: housed in cages of 15
- Diet (e.g. ad libitum): ground Oxoid pasteurized breeding diet; ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 1°C
- Humidity (%):50-60%
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: basic diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Basic diets containing 2000, 4000,8000,16000 mg/l (0.2, 0.4, 0-8 or 1.6%) Sunset Yellow FCF
DIET PREPARATION
- Rate of preparation of diet (frequency): Daily
- Mixing appropriate amounts with (Type of food): ground Oxoid pasteurized breeding diet - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 80 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000,4000,8000,16000 mg/kg (0.2, 0.4, 0.8 or 1.6% respectively)
Basis:
nominal in diet
- No. of animals per sex per dose:
- Control group:60 male and 60 females
Test group: 30 male and 30 females - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Cage side observations: avoid further fighting all the mice were caged individually from month 8. Any mouse showing signs of ill health was isolated, to be returned to its cage.
BODY WEIGHT: Yes - Time schedule for examinations:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at wk 13, 26 and 52 and from all surviving mice at wk 80.
- Anaesthetic used for blood collection: No
- Animals fasted: No data
- How many animals: ten male and ten female mice
- Parameters checked: hemoglobin concentration, packed cell volume and counts, Differential leucocyte counts and reticulocyte counts.
ORGAN WEIGHT: Yes
-Brain, heart, liver, kidneys, spleen, stomach, small intestine, caecum and testes were weighed - Sacrifice and pathology:
- SACRIFICE : Mice killed by exsanguination from the aorta under barbiturate anaesthesia.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
All tissues from the control mice and those fed 1.6% Sunset Yellow FCF were examined microscopically, while at the lower dietary levels examination was confined to the liver and kidney together with any tissue seen to be abnormal at autopsy. - Other examinations:
- Behavior and were weighed at 4-wk intervals throughout the study.
During the first half of the study it was noticed that there was a tendency for the male mice to fight. Bite lesions of the anogenital region were particularly frequent and these were associated with obstructions of the urinary tract. To avoid further fighting, all the mice were caged individually from month 8.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No changes in body-weight gains.
- 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:
- no effects observed
- Description (incidence and severity):
- No evidence of any haematological adverse effect due to the administration of Sunset Yellow FCF.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No significant differences between the organ weights or relative organ weights of the test groups and the corresponding controls.
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- NON-NEOPLASTIC- No differences between treated and control mice in the incidence or severity of the lesions seen.
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 16 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There were deaths in all groups during the study but there was no relationship between the number of deaths at any time and the dietary intake of Sunset Yellow FCF (Table 1). Many of the male mice dying or killed during the first half of the study were those that had been fighting.
Applicant's summary and conclusion
- Conclusions:
- The 80 weeks chronic repeated dose study on male and female Charles River CD mouse indicated that no effects observed on body weight, organ weight, haematology and histopathology.
Thus, on the basis of study results the NOAEL (no observed adverse effect level) was observed to be 16000 mg/kg diet. - Executive summary:
In order to determined the repeated oral toxicity ofSunset Yellow FCF, a 80weeks repeated dose toxicity study in Charles River CD mouse (male and female) was conducted at dose levels of 2000,4000,8000,16000 mg/kg (0.2, 0.4, 0.8 or 1.6% respectively) by oral diet route .
From experimental study effects observed as No changes in body-weight gains, no significant differences between the organ weights, no evidence of any adverse effect to hematological examinations, no differences between treated and control mice in the incidence or severity of the lesions seen at high dose level.
There were deaths in all groups during the study but there was no relationship between the number of deaths at any time and the dietary intake of Sunset Yellow FCF. Many of the male mice dying or killed during the first half of the study were those that had been fighting.
Thus, on the basis of above results the NOAEL (no observed adverse effect level) forSunset Yellow FCFwas considered to be 16000 mg/kg diet.
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