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EC number: 229-313-2 | CAS number: 6471-49-4
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from NTP.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Toxicology and Carcinogenesis Studies of C.I. Pigment Red 23 (CAS No. 6471-49-4) in F344 Rats and B6C3F1 Mice (Feed Studies)
- Author:
- NTP
- Year:
- 1 992
- Bibliographic source:
- NATIONAL TOXICOLOGY PROGRAM. Technical Report Series. No.411, November 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- 17 days repeated dose toxicity study of C.I. Pigment Red 23 in F344 male and female rats were observed to evaluate its toxic potential.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- EC Number:
- 229-313-2
- EC Name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Cas Number:
- 6471-49-4
- Molecular formula:
- C24H17N5O7
- IUPAC Name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material : 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Common name : 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide, C.I. Pigment Red 23
- Molecular formula : C24H17N5O7
- Molecular weight : 487.4263 g/mol
- Smiles notation : c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1)[N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
- InChl : 1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
- Substance type : Organic
- Physical state : Solid
Constituent 1
- Specific details on test material used for the study:
- Name of test material : 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Common name : 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide, C.I. Pigment Red 23
- Molecular formula : C24H17N5O7
- Molecular weight : 487.4263 g/mol
- Smiles notation : c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1)[N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
- InChl : 1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
- Substance type : Organic
- Physical state : Solid
-Purity: >96 %
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Frederick Cancer Research Center (Frederick, MD)
- Age at study initiation: 56 days old
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: rats were housed five per cage throughout the study
cage: Polycarbonate, solid bottom (Lab Products Inc., Garfield, NJ)
- Diet (e.g. ad libitum): NIH-07 rat, meal (Zeigler Bros., Inc., Gardners, PA), available ad libitum
- Water (e.g. ad libitum): Tap water (Birmingham Water Works)
in glass water bottles with stainless steel sippers (Edstrom Automatic Watering Systems, Waterford, WI), available ad
libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2-23.3 °C
- Humidity (%): 47%-61%
- Air changes (per hr): Minimum 15 change per hours
- Photoperiod (hrs dark / hrs light): 12 hours/day
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- PREPARATION OF DOSING SOLUTIONS: Not applicable
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): premix of NIH-07 rat as meal, with the appropriate amount of C.I. Pigment Red 23.
- Storage temperature of food: 2 weeks for 45 °C - Vehicle:
- other: NIH-07 rat, meal
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Not applicable
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): premix of NIH-07 rat as meal, with the appropriate amount of C.I. Pigment Red 23.
- Storage temperature of food: 2 weeks for 45 °C
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: 0, 6,000, 12,500, 25,000, 50,000 or 100,000 ppm - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Periodic analyses of the dosed-feed formulations were conducted at the study laboratory and at the analytical chemistry laboratory throughout. the studies
- Duration of treatment / exposure:
- from day 15 to 17th
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0, 6,000, 12,500, 25,000, 50,000 or 100,000 ppm (0, 1200, 2500, 5000, 10000, 50000 mg/kg/day)
- No. of animals per sex per dose:
- 5animals/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice/day
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once/week and at sacrifice
BODY WEIGHT: Yes
- Time schedule for examinations: once/week and at sacrifice
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): daily/cage (calculated per
animal)
- 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: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined.
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.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: No data sensory activity / grip strength / motor activity / other: No data - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Mean ±Standard deviation was observed.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all dose level 0, 1200, 2500, 5000, 10000, 50000 mg/kg/day of treated group compare to control.
- Mortality:
- no mortality observed
- Description (incidence):
- No significant mortality were observed at all dose level 0, 1200, 2500, 5000, 10000, 50000 mg/kg/day of treated group compare to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Differences in mean body weight change and weight gain of exposed group than control were not significant.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all dose level 0, 1200, 2500, 5000, 10000, 50000 mg/kg/day of treated group compare to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased erythrocyte count observed in all male dose groups and the two highest female dose groups, indicating a mild anemia
- 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 effect were observed at all dose level 0, 1200, 2500, 5000, 10000, 50000 mg/kg/day of treated group compare to control.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all dose level 0, 1200, 2500, 5000, 10000, 50000 mg/kg/day of treated group compare to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- No significant effect were observed at all dose level 0, 1200, 2500, 5000, 10000, 50000 mg/kg/day of treated group compare to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect were observed at this dose
- Remarks on result:
- other: No toxic effct were observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL value for substance C.I. Pigment Red 23 is considered to be 5000 mg/kg/day in F344 male and female rats for 17 days study.
- Executive summary:
17 days repeated dose toxicity study was conducted in F344 male and female rats by administratingC.I. Pigment Red 23 orally at doses0, 600, 1200, 2500, 5000, 10000 mg/kg/day. There were no clinical and mortality were observed. No biologically significant differences recorded in organ weights among exposed and control rats. Decreased erythrocyte count observed in the two highest female and male dose groups, indicating a mild anemia. Therefore, NOAEL value for substanceC.I. Pigment Red 23 is considered to be 5000 mg/kg in F344 female rats.
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