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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
Carcinogenicity
Administrative data
Description of key information
Two year carcinogenesis studies were conducted inB6C3F1 Mice. The substanceC.I.Pigment Red administrating orally at dose 230, 10,000, 25,000, or 50,000 ppm (1428.58, 3571.42 or 7142.86 mg/kg) to B6C3F1 Mice. Survival of all female dose groups and mid- and High-dose males was similar to that of the controls. Survival in low-dose (10,000 ppm) males was 10% less than that of the controls by week 20 and continued to be lower than control values throughout the study. This decrease in survival was associated with evidence of trauma and secondary septicemia caused by fighting. Body weights from all dose groups of each sex were within 10% of the untreated controls throughout the study. Feed consumption by both male and female mice was similar to that of the controls. No chemical-related increases in neoplasm incidence were observed in mice of either sex at any dose level. There was no evidence of carcinogenic activity of C.I. Pigment Red 23 in male and female B6C3FI mice. Therefore, the substance C.I. Pigment Red 23 was considered to be non-carcinogenic at 7142.86 mg/kg/day to F344 male and female mice.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: 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.
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Two year carcinogenesis studies were conducted by administrating C.I.Pigment Red 23 to B6C3F1 Mice.
- GLP compliance:
- not specified
- 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 % - Species:
- mouse
- Strain:
- B6C3F1
- 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: 63 days old
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: mice were housed five per cage from 13 December 1982 to 7 June 1984 (males) and 8 June 1984 (females), after which time they were housed individual1y because of excessive fighting.
- 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): 17.2°C-26.7°C
- Humidity (%): 22%-84%
- Air changes (per hr): minimum 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours/day - Route of administration:
- oral: feed
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): premix of NIH-07 mouse as meal, with the appropriate amount of C.I. Pigment Red 23.
- Storage temperature of food: 2 weeks for 45 °C - Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Daily
- Remarks:
- 0, 10,000, 25,000, or 50,000 ppm (1428.58, 3571.42 or 7142.86 mg/kg)
- No. of animals per sex per dose:
- 10 animals /dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Details on study design:
- Dose selection rationale: Because levels of C.I. Pigment Red 23 as high as 2500 or 50,000 mg/kg in the feed did not adversely affect survival and mean body weights in the 17-day and 13-week studies, nor cause any chemical-related lesions, doses of 0, 500, 1250, or 2500 mg/kg were selected for the 2-year studies. - 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/month
BODY WEIGHT: Yes
- Time schedule for examinations: once/week for 13 weeks, once/month thereafter and at sacrifice.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): daily/cage for one
week out of 4 and calculated per animal
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY: No data available
- 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 available a
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data available
- Animals fasted: No data available - How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available - Sacrifice and pathology:
- Scarifies And Pathology:
GROSS PATHOLOGY:
Yes
HISTOPATHOLOGY:
Yes - Statistics:
- Mean were observed.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- No. (mortality in low-dose (10,000 ppm) males was 60/34 less than that of the controls. This decrease in survival was associated with evidence of trauma and secondary septicemia caused by fighting.)
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights from all dose groups of each sex were within 10% of the untreated controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Feed consumption by both male and female mice was similar to that of the controls.
- 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):
- Hematology parameters of exposed group were similar to control group.
- 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
- Gross pathological findings:
- not specified
- Neuropathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Increase in hyperkeratosis and epithelial hyperplasia of the forestomach.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In male Forestomach:
epithelial hyperplasia (0/49, 1/48, 1/50, 7/48);
epithelial hyperkeratosis (0/49, 1/48, 3/50, 5/48)
In female Forestomach: epithelial hyperplasia (6/49, 14/49,43/50,47/49); epithelial hyperkeratosis (2149, 1,49, 3/50, 18/49) - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 7 142.86 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No neoplastic effct were observed
- Remarks on result:
- other: No neoplastic effect were observed.
- Conclusions:
- The substance C.I. Pigment Red 23 was considered to be non-carcinogenic to F344 male and female mice.
- Executive summary:
Two year carcinogenesis studies were conducted inB6C3F1 Mice. The substanceC.I.Pigment Red administrating orally at dose 230, 10,000, 25,000, or 50,000 ppm (1428.58, 3571.42 or 7142.86 mg/kg)toB6C3F1 Mice.
Survival of all female dose groups and mid- and High-dose males was similar to that of the controls. Survival in low-dose (10,000 ppm) males was 10% less than that of the controls by week 20 and continued to be lower than control values throughout the study. This decrease in survival was associated with evidence of trauma and secondary septicemia caused by fighting. Body weights from all dose groups of each sex were within 10% of the untreated controls throughout the study. Feed consumption by both male and female mice was similar to that of the controls.No chemical-related increases in neoplasm incidence were observed in mice of either sex at any dose level. There was no evidenceof carcinogenic activity of C.I. Pigment Red 23 in male and female B6C3FI mice. Therefore, the substance C.I. Pigment Red 23 was considered to be non-carcinogenic to F344 male and female mice.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 7 142.86 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Data is K2 from NTP
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available for the target chemical C.I. Pigment Red 23; IUPAC: 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; (6471-49-4) does not exhibit carcinogenic nature upon repeated exposure by oral exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Additional information
Carcinogenicity;
Various experimental studies were reviewed to determine the carcinogenic nature of target substance C.I. Pigment Red 23; IUPAC: 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; (6471-49-4)upon repeated exposure by oral route. The studies are as mentioned below fpr target substance:
Two year carcinogenesis studies were conducted inB6C3F1 Mice by NATIONAL TOXICOLOGY PROGRAM (NTP, Technical Report Series. No.411,1992)to evaluate the carcinogenic effect of of target substance C.I. Pigment Red 23; IUP C: 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl] -N-(3-nitrophenyl)naphthalene-2-carboxamide; (6471-49-4). The substanceC.I.Pigment Red administrating orally at dose 230, 10,000, 25,000, or 50,000 ppm (1428.58, 3571.42 or 7142.86 mg/kg) to B6C3F1 Mice. Survival of all female dose groups and mid- and High-dose males was similar to that of the controls. Survival in low-dose (10,000 ppm) males was 10% less than that of the controls by week 20 and continued to be lower than control values throughout the study. This decrease in survival was associated with evidence of trauma and secondary septicemia caused by fighting. Body weights from all dose groups of each sex were within 10% of the untreated controls throughout the study. Feed consumption by both male and female mice was similar to that of the controls. No chemical-related increases in neoplasm incidence were observed in mice of either sex at any dose level. There was no evidence of carcinogenic activity of C.I. Pigment Red 23 in male and female B6C3FI mice. Therefore, the substance C.I. Pigment Red 23 was considered to be non-carcinogenic to F344 male and female mice.
Supported by Two year toxicology and carcinogenesis study in F344 female Rats by NATIONAL TOXICOLOGY PROGRAM (NTP, Technical Report Series. No.411, 1992) to evaluate the carcinogenic effect of target substance C.I. Pigment Red 23; IUPAC: 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl] -N-(3-nitrophenyl)naphthalene-2-carboxamide; (6471-49-4). The study was conducted by administering of female rats doses of 0, 500, 1250, and 2500 mg/kg C.I. Pigment Red 23 in feed for 103 weeks. There were one renal tubule adenoma was observed in a high-dose female. There was no evidence of carcinogenic activity of C.1. Pigment Red 23 in female F344 rats fed diets containing 500, 1250 and 2500 mg/kg. Mononuclear cell leukemia occurred with a decreased incidence in female rats. Therefore, the NOAEL value for carcinogenicity of C.I. Pigment Red 23 in Female F344 rats is considered to be 2500mg/kg/day.
Supported by other Two year toxicology and carcinogenesis study in F344 male Rats by NATIONAL TOXICOLOGY PROGRAM (NTP, Technical Report Series. No.411, 1992) to evaluate the carcinogenic effect of target substance C.I. Pigment Red 23; IUPAC:3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N- (3-nitrophenyl)naphthalene-2-carboxamide; (6471-49-4) . The study was conducted by administering of male rats doses of 0, 500, 1250, and 2500 mg/kg C.I. Pigment Red 23 in feed for 103 weeks. Renal neoplasm was observed, the incidences are low and do not exceed the historical control range of 0% to 6% in male rats. Because of the low number of neoplasms in the high dose males, the residual halves of the formalin-fixed kidneys from all control and high-dose males were step sectioned to provide approximately eight additional sections for microscopic examinationThere were four renal tubule cell adenomas or carcinomas were observed in kidney of males in the two highest dose groups. This was equivocal evidence of carcinogenic activity of C.I. Pigment Red 23 in male F344 rats as evidenced by a marginally increased incidence of renal tubule cell neoplasms. Mononuclear cell leukemia occurred with a decreased incidence also the severity of kidney nephropathy was increased in exposed male rats. The result for carcinogenicity of C.I. Pigment Red 23 in male F344 rats as showing a marginal increase of neoplasms that may be chemical-related. Therefore, the NOAEL value for carcinogenicity of C.I. Pigment Red 23 in male F344 rats is considered to be 2500mg/kg/day.
Based on the data available for the target chemical C.I. Pigment Red 23; IUPAC:3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl] -N- (3-nitrophenyl)naphthalene-2-carboxamide; (6471-49-4) does not exhibit carcinogenic nature upon repeated exposure by oral exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
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