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EC number: 235-437-8 | CAS number: 12227-62-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 16185:1.
- 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:
- toxicity to reproduction
- Remarks:
- other: Repeated dermal toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproductive toxicity study of test material was performed in mice by repeated dermal application for 18 months.
- Author:
- CARSON et al.
- Year:
- 1 984
- Bibliographic source:
- J. Toxicol.-Cut. & Ocular Toxicol.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Repeated dermal toxicity study of FD&C Red 4 in mice
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
- EC Number:
- 224-909-9
- EC Name:
- Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate
- Cas Number:
- 4548-53-2
- Molecular formula:
- C18H16N2O7S2.2Na
- IUPAC Name:
- disodium 3-[(2,4-dimethyl-5-sulfonatophenyl)diazenyl]-4-hydroxynaphthalene-1-sulfonate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): FD&C Red 4
- Molecular formula (if other than submission substance):C18H14N2O7S2.2Na C18H16N2O7S2.2Na
- Molecular weight (if other than submission substance): 480.4276 g/mole
- Substance type: Orgainc
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): FD&C Red 4
- Molecular formula (if other than submission substance):C18H14N2O7S2.2Na C18H16N2O7S2.2Na
- Molecular weight (if other than submission substance): 480.4276 g/mole
- Substance type: Orgainc
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: (P) : No data available
- Weight at study initiation: (P) : 17 to 25 g
- Fasting period before study: No data available
- Housing: Animals of sex were housed five per cage
- Diet (e.g. ad libitum): Purina Laboratory Chow , ad libitum
- Water (e.g. ad libitum): Fresh water, ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
Administration / exposure
- Route of administration:
- dermal
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Distilled water
- Details on mating procedure:
- No data available
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- 19.5 months
- Frequency of treatment:
- Twice weekly
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.0 % (1500 mg/kg bw/day)
Basis:
nominal conc.
- No. of animals per sex per dose:
- Total: 300
0 mg/kg/bw/day : 100 males and 100 females
1500 mg/kg bw/day: 50 males and 50 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Survival, Body weight, visible or palable growth and behavior were examined.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P0)
No effect on survival of treated mice were obserevd as compared to control.
Clinical signs:
No abnormalities were observed in treated mice as compared to control.
Body weight and food consumption
Body weight:
No significant effect was observed on body weight of treated mice as compared to control.
Test substance intake: No data available
Reproductive function: estrous cycle: No data available
Reproductive function: sperm measures: No data available
Reproductive performance: No data available
Organ weights: No data available
Gross pathology: Lymphoma of Absominal, Involving Viscera, Adenocarcinoma of Mammary Gland, Subcutaneous papillary adenocarcinoma were observed in treated female mice. The observed effect were similar to control.
Histopathology: All grades Malignant lymphoma and Variation in nuclear morphology in Liver, Infarction, Malignant and Myeloid metaplasia, Leukocytic aggregations in Spleen, all grades Malignant lymphoma , Leukemic and round cell infiltration and Leukocytic aggregation in Kidneys , Malignant lymphoma in Lymph Nodes, Malignant lymphoma, Inflammation, pneumonitis, bronchitis, Necrotic changes in Lungs and all grades Malignant lymphoma in Thymus were observed in male and female treated mice.
No significant difference in the incidence of this lesion were observed as compared to control and considered to be not treatment related.
other findings No data available
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effect on survival, clinical sign, body weight, gross pathology and histopathology of reproductive organ
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: No data available
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- other: No data available
- Generation:
- F1
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: No data available
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Skin Painting Studies in Mice: Percent Survival and Survival Index
|
|
6 |
12 |
18 |
19.5 |
||||
Series |
Sex |
%Sa |
SIb |
%S |
SI |
%S |
SI |
%S |
SI |
FD&C Red 4 |
M |
66 |
80 |
30 |
64 |
12 |
49 |
12 |
46 |
|
F |
76 |
91 |
26 |
68 |
2 |
48 |
2 |
44 |
A%S denotes percent survival.
bSI, survival index: %ratio of mouse days survived compared to anticipated number of days if all the surviving animals lived to the end of the experiment.
C0.1%sodium lauryl sulfate.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1500 mg/kg bw/day when Swiss-Webster male and female mice were treated with FD&C Red 4.
- Executive summary:
In a repeated dose dermal toxicity study, Swiss-Webster male and female mice were treated with FD &C Red 4in the concentration of 1500 mg/kg bw/day in distilled water applied twice weekly on 6 cm2 dorsal area of skin. No effects were observed on survival, clinical sign and body weight of treated male and female mice as compared to control. Similarly, lesion in Mammary Gland and Subcutaneous papillary were observed gross pathologically in treated mice, but the observed effect was similar to control. In addition, All grades Malignant lymphoma and Variation in nuclear morphology in Liver, Infarction, Malignant and Myeloid metaplasia, Leukocytic aggregations in Spleen, all grades Malignant lymphoma , Leukemic and round cell infiltration and Leukocytic aggregation in Kidneys , Malignant lymphoma in Lymph Nodes, Malignant lymphoma, Inflammation, pneumonitis, bronchitis and Necrotic changes in Lungs and all grades Malignant lymphoma in Thymus were observed in male and female treated mice. No significant difference in the incidence of this lesion were observed as compared to control and considered to be not treatment related. Therefore, NOAEL was considered to be 1500 mg/kg bw/day when Swiss-Webster male and female mice were treated with FD&C Red 4.
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