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EC number: 222-656-9 | CAS number: 3567-66-6
- 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
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Long-term Feeding Study in Mice
- Author:
- International Research and Development Corporation
- Year:
- 2 007
- Bibliographic source:
- Scientific Committee on Consumer Products (SCCP), OPINION ON Acid Red 33, COLIPA n° C22, 2007 page no -16-17
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Principles of method if other than guideline:
- Combine repeated dose and carcinogenicity study of D&C Red 33 in mice
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 222-656-9
- EC Name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3567-66-6
- Molecular formula:
- C16H13N3O7S2.2Na
- IUPAC Name:
- disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Reference substance name:
- D&C Red 33
- IUPAC Name:
- D&C Red 33
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): D&C Red 33 - Molecular formula (if other than submission substance): C16H11N3Na2O7S2- Molecular weight (if other than submission substance): 467 g/mole- Substance type: Organic- Physical state: PowderPurity: 88% - Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: No data available - Age at study initiation: No data available - Weight at study initiation: No data available - Fasting period before study: No data available - Housing: No data available - Diet (e.g. ad libitum): Purina Rodent Chow, ad libitum- Water (e.g. ad libitum): No data available - 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 IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Purina Rodent Chow
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: D&C Red 33 was fed in the diet at dosage levels of 0.1, 1.0 and 5.0%. (dose to 150, 1502, and 8764 mg/kg bw/day for males and 181, 1809, and 10,362 mg/kg bw/day for females)DIET PREPARATION- Rate of preparation of diet (frequency): No data available - Mixing appropriate amounts with (Type of food): Purina Rodent Chow - Storage temperature of food: No data available VEHICLE- Justification for use and choice of vehicle (if other than water): Purina Rodent Chow - Concentration in vehicle:0, 150, 1502, and 8764 mg/kg bw/day for males and 0, 181, 1809, and 10,362 mg/kg bw/day for females - Amount of vehicle (if gavage): No data available - Lot/batch no. (if required): No data available - Purity: No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 24 months
- Frequency of treatment:
- Daily
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 150, 1502, and 8764 mg/kg bw/day for males and 0, 181, 1809, and 10,362 mg/kg bw/day for females Basis:actual ingested
- No. of animals per sex per dose:
- Total: 6000 mg/kg bw/day: 120 male , 120 female 150 mg/kg bw/day: 60 male 1502 mg/kg bw/day: 60 male 8764 mg/kg bw/day: 60 male 181 mg/kg bw/day: 60 female1809 mg/kg bw/day: 60 female10362 mg/kg bw/day: 60 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule: two – three times daily - Cage side observations checked in table [No.?] were included: Morbidity and mortality were observed. DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: two – three times dailyDERMAL IRRITATION (if dermal study): No data available - Time schedule for examinations: No data available BODY WEIGHT: Yes- Time schedule for examinations: Weekly during the first 14 weeks of study, biweekly (the second 7 days of every two weeks) during the next 12 weeks and monthly (7 days during the second week of each .month) thereafter.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes - 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: Yes 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 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: At 3, 6, 12, 18, and 24 months- Anaesthetic used for blood collection: No data available - Animals fasted: No data available - How many animals: 80 animals were examined - Parameters checked in table [No.?] were examined. Erythrocyte, haemoglobin and haematocrit, reticulocytes and Leucocytes were examined. CLINICAL CHEMISTRY: No data available - 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 OTHER: No data available
- Sacrifice and pathology:
- GROSS PATHOLOGY: No data available HISTOPATHOLOGY: Yes
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- 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:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Mortality: When treated with 8764 and 10,362 mg/kg bw/day, decrease in survival were observed in treated male mice at week 57 and in female mice at week 74 as compared to control. Clinical sign: When treated with 1502 and 8764 mg/kg bw/day in male and 1809 and 10,362 mg/kg bw/day in female, hair and exposed skin areas appeared purple in colour and the urine and faeces appeared red as compared to control. When treated with 150 mg/kg bw/day in male and 181 mg/kg bw/day in female, skin areas appeared pink in colour, faeces appeared brownish red, and urine appeared orange and pink in treated of male and female mice as compared to control. Body weight and weight gain: When treated with 8764 mg/kg bw/day in male and 10,362 mg/kg bw/day in female, change in body weight were observed in treated male and female mice as compared to control. Food consumption: No effect on food consumption was observed in treated mice as compared to control. Compound intake: 0.1, 1.0 and 5.0% corresponded to 150, 1502, and 8764 mg/kg bw/day for males and 181, 1809, and 10,362 mg/kg bw/day for femalesFood efficiency Water consumption & compound intake: No data available Ophthalmoscopic examination: No data available Haematology: When treated with 10,362 mg/kg bw/day in female, continued increase in reticulocytes were observed in treated mice as compared to control. When treated with 1502 mg/kg bw/day in male and 1809 mg/kg bw/day in female, significant increase in reticulocytes and Leucocytes level at 18 and 24 months were observed in treated mice as compared to control. When treated with 181 mg/kg bw/day in female, significant increase in Leucocytes level at 24 months was observed in treated mice as compared to control. Decreases in erythrocyte, haemoglobin and haematocrit values and increases in reticulocytes in most treated groups were considered indicative of a dosage-related anaemia at the 6 and 12 month evaluations.Clinical chemistry: No data available Urinalysis: No data available Neuro behavior: No data available Organ WeightsNo data available Gross Pathology: No data availableHistopathology: non-neoplastic: When treated with 8764 mg/kg bw/day in male and 10,362 mg/kg bw/day in female, chronic nephritis, hydronephrosis and tubular pigment in kidneys, Pigment in liver and spleen was observed in treated mice as compared to control. Histopathology: neoplastic: No data available
- Relevance of carcinogenic effects / potential:
- Non carcinogenic
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effect on survival, body weight, food consumption, hematology and histopathology
- Remarks on result:
- other:
- Remarks:
- Effect type: other: Non carcinogenic (migrated information)
- Dose descriptor:
- LOAEL
- Effect level:
- 181 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Effect on Survival, body weight, hematology and histopathology
- Remarks on result:
- other:
- Remarks:
- Effect type: other: Non carcinogenic (migrated information)
Applicant's summary and conclusion
- Conclusions:
- Non carcinogenic NOAEL was considered to be 150 mg/kg bw/day for male mice and LOAEL was 181 mg/kg bw/day for female mice when Charles River CD-1 male and female mice were treated with D&C Red 33.
- Executive summary:
In a Combine repeated dose and carcinogenicity study, Charles River CD-1 male and female mice were treated with D&C Red 33 in the concentration of 0, 150, 1502, and 8764 mg/kg bw/day for males and 0, 181, 1809, and 10,362 mg/kg bw/day for females orally in Purina Rodent Chow diet. Decrease in survival was observed in treated male mice at week 57 and in female mice at week 74 at 8764 and 10,362 mg/kg bw/day. Hair and exposed skin areas appeared purple in colour and the urine and faeces appeared red at 1502 and 8764 mg/kg bw/day in male and 1809 and 10,362 mg/kg bw/day in female and skin areas appeared pink in colour, faeces appeared brownish red, and urine appeared orange and pink in 150 mg/kg bw/day in male and 181 mg/kg bw/day in female mice as compared to control. Change in body weight at 8764 mg/kg bw/day in male and 10,362 mg/kg bw/day in female mice were observed. No effect on food consumption was observed in treated mice as compare to control. Continued increase in reticulocytes at 10,362 mg/kg bw/day and significant increase in Leucocytes level at 24 months were observed at 181 mg/kg bw/day treated female mice and significant increase in reticulocytes and Leucocytes level at 18 and 24 months were observed at 1502 mg/kg bw/day in male and 1809 mg/kg bw/day in female treated mice as compared to control. Decreases in erythrocyte, haemoglobin and haematocrit values and increases in reticulocytes in most treated groups were considered indicative of a dosage-related anaemia at the 6 and 12 month evaluations. In addition, chronic nephritis, hydronephrosis and tubular pigment in kidneys, Pigmentin liver and spleen were observed at 8764 mg/kg bw/day in male and 10,362 mg/kg bw/day in female treated mice as compared to control. Therefore, Non carcinogenic NOAEL was considered to be 150 mg/kg bw/day for male mice and LOAEL was 181 mg/kg bw/day for female mice when Charles River CD-1 male and female mice were treated with D&C Red 33 orally in feed for 24 months.
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