Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 231-494-8 | CAS number: 7585-41-3
- 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: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Performed prior to introduction of GLP. Limited details reported. Designed mainly to detect skin cancer. Full histopathology only performed for 5 of 50 animals per dose group.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin Painting Studies in Mice with 14 FD&C and D&C Colors
- Author:
- Carson S
- Year:
- 1 984
- Bibliographic source:
- J. Toxicol. - Cut. and Ocular Toxicol. 3 (4), 357 - 370
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 18 months application twice weekly of 50 mg/kg bw onto shaved skin of mice with histopathology of skin and major organs
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 226-109-5
- EC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5281-04-9
- Molecular formula:
- C18H14N2O6S.Ca
- IUPAC Name:
- calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate
- Test material form:
- solid: nanoform
- Details on test material:
- - Name of test material (as cited in study report): D&C Red 7
- Substance type: pigment
- Physical state: solid
- Analytical purity: 98%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: W4602
- Expiration date of the lot/batch: no data
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): D&C Red 7
- Substance type: pigment
- Physical state: solid
- Analytical purity: 98%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: W4602
- Expiration date of the lot/batch: no data
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: not applicable
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on exposure:
- Application of 0.1 ml of a 1% suspension in water
application site: 6 cm2
Initially. the hair on the dorsal area of each animal was clipped with an animal clipper free of lubricatirig oil. Subsequent periodic clipping was performed according to the rate of hair growth.
The test item suspension was prepared fresh weekly - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 471 days (ca 18 months)
- Frequency of treatment:
- twice per week
Doses / concentrations
- Dose / conc.:
- 0.166 mg/cm² per day (nominal)
- No. of animals per sex per dose:
- 50 for test item
150 for control
50 for positive control - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on human exposure from use in lipstick
- Positive control:
- 3,4-benzpyrene, dissolved in acetone
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations not included
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
DERMAL IRRITATION (if dermal study): No data
BODY WEIGHT: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (preparation of: brain, pituitary, thyroid, thymus, liver, spleen, kidney, adrenal, stomach, small and large intestines, urinary bladder, axillary lymph nodes, testes, ovary, skin from area of treatment, any tissue massess, grossly abnormal organs; complete pathology only for each five males and females; skin and grossly abnormal organs for all animals) - Statistics:
- no data
Results and discussion
Results of examinations
- Details on results:
- No test-item related effects were observed.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- >= 50 other: mg/kg bw twice weekly
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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