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EC number: 243-717-6 | CAS number: 20298-05-9
- 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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
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
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- 80 weeks chronic repeated dose oral toxicity study of Sunset Yellow FCF was performed to determine its chronic toxic nature
- GLP compliance:
- not specified
- Limit test:
- no
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 g/mol
- Substance type: organic
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Sunset Yellow FCF
- IUPAC name: disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Molecular formula: C16H12N2O7S2.2Na
- Molecular weight: 454.38 g/mol
- Substance type: organic
- Physical state: solid
- Impurity: Dye content*, min. 85%; subsidiary dyes*, max 3%; matter volatile at 135°C *, max 10%; matter insoluble in water*, max 0.1%; matter soluble in diisopropyl ether*, max 0.2%; chloride and sulphate (as sodium salts)*, max 5.0%; copper*, max 10 ppm; arsenic, max 1 ppm; lead*, max l0 ppm; heavy metals (as sulphides)*, not producing more intense colour than reference standard.
Test animals
- Species:
- mouse
- Strain:
- other: Charles River CD
- Details on species / strain selection:
- No data
- 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): water 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: The test chemical was mixed with feed at dose levels of 0, 100, 200, 400, 800 mg/l (0, 0.2, 0.4, 0.8 or 1.6%)
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): Oxoid pasteurized breeding diet
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Oxoid pasteurized breeding diet
- Concentration in vehicle: 0, 100, 200, 400, 800 mg/l (0, 0.2, 0.4, 0.8 or 1.6%)
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 80 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 200, 400, 800 mg/l (0, 0.2, 0.4, 0.8 or 1.6%)
Basis:
nominal in diet
- No. of animals per sex per dose:
- Control group:60 male and 60 females
Test group:
100 mg/Kg: 30 male and 30 females
200 mg/Kg: 30 male and 30 females
400 mg/Kg: 30 male and 30 females
800 mg/Kg: 30 male and 30 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Continued surveillance
- Cage side observations checked in table [No.?] were included. Any abnormalities in condition and behavior
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: At 4 weeks interval throughout the study
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: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD 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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: wk 13, 26 and 52 and from all surviving mice at wk 80
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 10/sex from control group and animals fed 400 and 800 mg/Kg
- Parameters checked in table [No.?] were examined. Haemoglobin concentration and packed cell volume and counts were made of erythrocytes and total leucocytes. Differential leucocyte counts and reticulocyte counts were made on the blood from the mice fed on the control diet and from those given diet containing 1.6% Sunset Yellow FCF at wk 26, 52 and 80, and reticulocyte counts were also carried out for these groups at wk 13.
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
IMMUNOLOGY: Yes / No / Not specified
- Time schedule for examinations:
- How many animals:
- Dose groups that were examined:
- Parameters checked in table [No.?] were examined.
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, At autopsy, all macroscopic abnormalities were noted and the brain, heart, liver, kidneys, spleen, stomach, small intestine, caecum and testes were weighed.
HISTOPATHOLOGY: Yes, the brain, heart, liver, kidneys, spleen, stomach, small intestine, caecum and testes together with salivary gland, thyroid, adrenals, lymph
nodes, pancreas, pituitary, ovaries, uterus, urinary bladder, lungs, colon, rectum, spinal cord, skeletal muscle and any other tissue that appeared abnormal were preserved in 10% buffered formalin. Paraffin-wax sections of these tissues were stained with haemotoxylin and eosin. All tissues from the control mice and those fed 800 mg/Kg 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.
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- There were deaths in all groups during the study and there was no relationship between the number of deaths at any time and the dietary intake of Sunset Yellow FCF
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The terminal body weights and the body-weight gains were similar in all groups.
- 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
- Immunological 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Distension of the bladder, frequently associated with hydroureter and hydronephosis was noted. Pus and hard protein deposits were found in the bladders of many of the mice and in a number of cases it was possible to show that an obstruction had occurred in the urethra in the region of the bulbo-urethral complex. After the male mice were put into individual cages, there was a marked reduction in the number showing this syndrome, although isolated cases of urinary retention were seen throughout the study.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No differences between treated and control mice in the incidence or severity of the lesions seen. There as an unusually high incidence of pyelonephritis and chronic inflammation of the bladder and urethra, but these lesions occurred mainly in the male mice killed because of urinary retention in the early stages of the study.
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- Of the malignant tumours found, lymphomas and reticulum-cell neoplasms occurred in treated and control mice. In addition a splenic haemangiosarcoma and a mammary carcinoma were found in the female mice fed on the diet containing the lowest level of Sunset Yellow FCF (100 mg/Kg). A single tumour of the Harderian gland was found in a female from the group given the 1.6% level. The commonest benign tumours were pulmonary adenomas and benign cysts in the ovary, found with a similar frequency in treated and control mice. The only other tumour occurring in treated mice without a similar finding in the controls was a granulosa-cell tumour of the ovary in a mouse given 800 mg/Kg Sunset Yellow FCF.
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 800 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- other: No significant alterations were noted between the treated and control animals
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1. Cumulative death record of mice fed Sunset Yellow FCF at dietary levels of 0-1.6 % for 80 wk
Wk no. |
Cumulative mortality |
|||||||||
Males |
Females |
|||||||||
0 |
0.2 |
0.4 |
0.8 |
1.6 |
0 |
0.2 |
0.4 |
0.8 |
1.6 |
|
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
16 |
0 |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
24 |
5 |
6 |
2 |
5 |
2 |
1 |
0 |
0 |
0 |
1 |
32 |
7 |
10 |
6 |
8 |
6 |
2 |
0 |
0 |
0 |
2 |
40 |
9 |
12 |
7 |
9 |
9 |
6 |
0 |
1 |
1 |
2 |
48 |
13 |
12 |
9 |
9 |
10 |
11 |
0 |
1 |
2 |
6 |
56 |
16 |
16 |
9 |
12 |
10 |
15 |
1 |
3 |
3 |
7 |
64 |
19 |
16 |
9 |
13 |
11 |
16 |
2 |
5 |
5 |
7 |
72 |
23 |
18 |
14 |
14 |
16 |
21 |
7 |
9 |
5 |
9 |
80 |
27 |
21 |
17 |
16 |
19 |
26 |
10 |
12 |
7 |
14 |
Table 2. Mean body weights of mice fed on diets containing 0-1.6% Sunset Yellow FCF for 80 wk
Dietary level (%) |
Body weight (g) at week |
Weight gain (g) at wk 81 |
|||||
0 |
13 |
33 |
49 |
65 |
81 |
||
Males |
|||||||
0 |
35.8 |
46.7 |
48.5 |
48.5 |
51.7 |
49.4 |
13.6 |
0.2 |
26.4 |
46.6 |
48.9 |
48.6 |
50.1 |
48.6 |
12.2 |
0.4 |
36.0 |
46.8 |
49.2 |
48.7 |
51.5 |
50.1 |
14.1 |
0.8 |
35.7 |
46.0 |
48.0 |
46.4 |
50.8 |
48.5 |
12.8 |
1.6 |
35.6 |
47.2 |
50.2 |
49.8 |
51.0 |
49.4 |
13.8 |
Females |
|||||||
0 |
27.9 |
42.5 |
49.4 |
45.0 |
48.3 |
45.1 |
17.2 |
0.2 |
28.1 |
44.0 |
52.8 |
46.0 |
50.4 |
49.8 |
21.7 |
0.4 |
28.3 |
41.5 |
50.1 |
43.9 |
49.6 |
45.9 |
17.6 |
0.8 |
27.7 |
42.1 |
50.8 |
44.2 |
50.0 |
48.7 |
21.0 |
1.6 |
27.5 |
41.7 |
49.1 |
44.9 |
51.5 |
48.0 |
20.5 |
Table 3. Relative organ weights of mice fed diets containing 0-1.6% Sunset Yellow FCF for 80 wk
Sex and dose |
No. of mice examined |
Relative organ weights (g/100 g bw) |
Terminal bw (g) |
||||||||
Brain |
Heart |
Liver |
Spleen |
Kidneys |
Stomach |
Small intestine |
Caecum |
Testes |
|||
Male |
|||||||||||
0 |
28 |
1.15 |
0.64 |
6.66 |
0.51 |
1.83 |
0.91 |
4.47 |
0.60 |
0.57 |
47 |
0.2 |
8 |
1.22 |
0.62 |
6.22 |
0.49 |
1.89 |
1.07 |
4.67 |
0.71 |
0.69 |
45 |
0.4 |
11 |
1.23 |
0.64 |
6.09 |
0.48 |
2.05 |
0.95 |
4.36 |
0.68 |
0.68 |
44 |
0.8 |
12 |
1.13 |
0.64 |
6.49 |
0.58 |
1.96 |
1.00 |
4.69 |
0.73 |
0.60 |
45 |
1.6 |
10 |
1.17 |
0.70 |
6.87 |
0.59 |
1.89 |
0.96 |
4.96 |
0.65 |
0.63 |
46 |
Females |
|||||||||||
0 |
25 |
1.41 |
0.56 |
5.49 |
0.90 |
1.41 |
1.18 |
4.26 |
0.67 |
- |
39 |
0.2 |
18 |
1.26 |
0.52 |
5.48 |
0.79 |
1.40 |
1.00 |
4.19 |
0.62 |
- |
42 |
0.4 |
15 |
1.38 |
0.56 |
6.51 |
0.83 |
1.44 |
1.07 |
5.11 |
0.74 |
- |
39 |
0.8 |
21 |
1.29 |
0.55 |
5.29 |
0.69 |
1.40 |
1.02 |
4.00 |
0.64 |
- |
42 |
1.6 |
12 |
1.32 |
0.56 |
6.34 |
0.98 |
1.41 |
1.05 |
3.72 |
0.63 |
- |
41 |
Table 4. Results of haematological examinations in mice fed on diets containing 0-1.6% Sunset Yellow FCF for 80 wk
Sex and dose |
No. of mice examined |
Hb (g/100mL) |
Pvc (%) |
Rbc (106/mm3) |
Retics (% of RBC) |
Leucocytes |
||||
Total (103/mm3) |
Differential |
|||||||||
N |
E |
L |
M |
|||||||
|
Week 52 |
|||||||||
Males |
|
|
|
|
|
|
|
|
|
|
0 |
10 |
12.5 |
47 |
8.18 |
3.7 |
17.07 |
22 |
0 |
72 |
6 |
0.8 |
10 |
11.9 |
45 |
4.84 |
- |
11.68 |
- |
- |
- |
- |
1.6 |
10 |
11.0 |
44 |
7.65 |
2.3 |
10.63 |
16 |
0 |
82 |
2 |
Females |
|
|
|
|
|
|
|
|
|
|
0 |
10 |
14.2 |
47 |
8.11 |
3.2 |
6.59 |
20 |
0 |
78 |
2 |
0.8 |
10 |
12.6 |
47 |
8.32 |
- |
8.60 |
- |
- |
- |
- |
1.6 |
10 |
11.0 |
44 |
7.54 |
2.3 |
7.61 |
23 |
0 |
76 |
1 |
|
Week 80 |
|||||||||
Males |
|
|
|
|
|
|
|
|
|
|
0 |
31 |
12..4 |
39 |
6.69 |
5.5 |
5.60 |
44 |
0 |
54 |
2 |
0.2 |
9 |
13.2 |
37 |
6.62 |
- |
5.19 |
- |
- |
- |
- |
0 |
13 |
11.9 |
38 |
6.77 |
- |
4.29 |
- |
- |
- |
- |
0.8 |
12 |
12.2 |
38 |
6.49 |
- |
5.33 |
- |
- |
- |
- |
1.6 |
10 |
13.5 |
40 |
6.96 |
6.2 |
6.25 |
52 |
0 |
45 |
3 |
Females |
|
|
|
|
|
|
|
|
|
|
0 |
31 |
12.7 |
40 |
6.95 |
5.8 |
6.02 |
61 |
0 |
31 |
8 |
0.2 |
19 |
12.9 |
41 |
6.96 |
- |
4.97 |
- |
- |
- |
- |
0 |
18 |
12.5 |
39 |
6.70 |
- |
6.00 |
- |
- |
- |
- |
0.8 |
23 |
12.7 |
40 |
6.74 |
- |
5.97 |
- |
- |
- |
- |
1.6 |
12 |
12.6 |
40 |
6.47 |
6.3 |
5.63 |
64 |
0 |
33 |
3 |
Table 5. Incidence of histopathological abnormalities (excluding tumaurs) found in mice fed diets containing 0-1"6% Sunset Yellow FCF for 80 wk
Organ and histological finding |
No. of mice affected |
|||||||||
Male |
Female |
|||||||||
0 |
0.2 |
0.4 |
0.8 |
1.6 |
0 |
0.2 |
0.4 |
0.8 |
1.6 |
|
50 |
26 |
30 |
27 |
1.9 |
47 |
29 |
27 |
27 |
29 |
|
Lung |
|
|
|
|
|
|
|
|
|
|
Chronic inflammatory infiltration |
3 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
Liver |
|
|
|
|
|
|
|
|
|
|
Amyloidosis |
17 |
7 |
7 |
6 |
5 |
5 |
5 |
7 |
7 |
4 |
Fatty degeneration |
7 |
1 |
4 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
Spleen |
|
|
|
|
|
|
|
|
|
|
Amyloidosis |
11 |
10 |
5 |
4 |
2 |
0 |
0 |
0 |
0 |
0 |
Kidney |
|
|
|
|
|
|
|
|
|
|
Degenerative changes |
13 |
4 |
3 |
0 |
1 |
5 |
3 |
3 |
1 |
4 |
Pyelonephritis |
4 |
6 |
2 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
Bladder |
|
|
|
|
|
|
|
|
|
|
Chronic inflammation |
3 |
5 |
4 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
Urethra |
|
|
|
|
|
|
|
|
|
|
Chronic inflammation |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Heart |
|
|
|
|
|
|
|
|
|
|
Interstitial fibrosis |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Non-specific |
|
|
|
|
|
|
|
|
|
|
Lymphoid hyperplasia |
2 |
0 |
0 |
0 |
0 |
12 |
0 |
3 |
1 |
4 |
Chronic subcutaneous |
|
|
|
|
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abscess |
0 |
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1 |
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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 considered to be 800 mg/kg diet.
- Executive summary:
Repeated oral toxicity of Sunset Yellow FCF was determined by performing a 80 weeks repeated dose toxicity study usiing Charles River CD mouse (male and female) at dose levels of 0, 100, 200, 400 or 800 mg/Kg (0.2, 0.4, 0.8 or 1.6% respectively) by oral diet route. The animals were observed for clinical signs, mortality, body weight changes, hematology and were subjected to gross and histopathology. The feeding of Sunset Yellow FCF did not adversely affect the death rate within the groups, the rate of body-weight gain, the organ weights or the haematological findings. The incidence and severity of the histopathological findings were similar in treated and control mice and there was no evidence of an increased incidence of tumours in the mice given Sunset Yellow FCF. Distension of the bladder, frequently associated with hydroureter and hydronephosis was noted. Pus and hard protein deposits were found in the bladders of many of the mice and in a number of cases it was possible to show that an obstruction had occurred in the urethra in the region of the bulbo-urethral complex. After the male mice were put into individual cages, there was a marked reduction in the number showing this syndrome, although isolated cases of urinary retention were seen throughout the study. Of the malignant tumours found, lymphomas and reticulum-cell neoplasms occurred in treated and control mice. In addition a splenic haemangiosarcoma and a mammary carcinoma were found in the female mice fed on the diet containing the lowest level of Sunset Yellow FCF (100 mg/Kg). A single tumour of the Harderian gland was found in a female from the group given the 1.6% level. The commonest benign tumours were pulmonary adenomas and benign cysts in the ovary, found with a similar frequency in treated and control mice. The only other tumour occurring in treated mice without a similar finding in the controls was a granulosa-cell tumour of the ovary in a mouse given 800 mg/Kg Sunset Yellow FCF. Thus, on the basis of above results the NOAEL (no observed adverse effect level) for Sunset Yellow FCF was considered to be 800 mg/kg diet.
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