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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- A Multigeneration Study in Rats of D&C Red 33 in the Diet
- 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 -19
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Multigeneration Study
- Principles of method if other than guideline:
- Multigeneration Study of D&C Red 33 in rats
- GLP compliance:
- not specified
- Limit test:
- no
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: Powder- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- 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 5002, 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
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Purina Rodent Chow 5002
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: No data available DIET PREPARATION- Rate of preparation of diet (frequency): No data available - Mixing appropriate amounts with (Type of food): Purina Rodent Chow 5002 - Storage temperature of food: No data available VEHICLE- Justification for use and choice of vehicle (if other than water): Purina Rodent Chow 5002 - Concentration in vehicle: 0, 0.25, 2.5; 7.5 and 25 mg/kg bw/day - 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
- Details on mating procedure:
- - M/F ratio per cage:: No data available- Length of cohabitation:: No data available- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancyNo data available- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.: No data available- Further matings after two unsuccessful attempts: [no / yes (explain)]: No data available- After successful mating each pregnant female was caged (how):: No data available- Any other deviations from standard protocol:F0: 20 animals per sex per dose levelF1a: mating on day 100F1b and F1c: mating at least 10 day laterF2a: mating of 20 F1 animals randomly selectedF3: mating of 20 F2b littersF0 parental animals were mated twice (each group 20 males and 20 females), to produce two litters and the F1 parents were mated to produce three litters and the F2 parents were mated once to produce the F3a litters.
- Duration of treatment / exposure:
- 110 days
- Frequency of treatment:
- Daily
- Duration of test:
- More than 110 days
- No. of animals per sex per dose:
- Total: 600F0 generation 0 mg/kg bw/day: 20 male, 20 female 0.25 mg/kg bw/day: 20 male, 20 female2.5 mg/kg bw/day: 20 male, 20 female7.5 mg/kg bw/day: 20 male, 20 female25.0 mg/kg bw/day: 20 male, 20 femaleF1 generation 0 mg/kg bw/day: 20 male, 20 female 0.25 mg/kg bw/day: 20 male, 20 female2.5 mg/kg bw/day: 20 male, 20 female7.5 mg/kg bw/day: 20 male, 20 female25.0 mg/kg bw/day: 20 male, 20 femaleF2 generation 0 mg/kg bw/day: 20 male, 20 female 0.25 mg/kg bw/day: 20 male, 20 female2.5 mg/kg bw/day: 20 male, 20 female7.5 mg/kg bw/day: 20 male, 20 female25.0 mg/kg bw/day: 20 male, 20 female
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Survival, clinical sign, Body weight and food consumption and Histopathology were examined.
- Ovaries and uterine content:
- No data available
- Fetal examinations:
- Survival, clinical sign, Body weight and food consumption were examined.
- Statistics:
- No data available
- Indices:
- Fertility indices, gestation anomalies, viability and survival of the pups were examined.
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effectsDetails on maternal toxic effects:Mortality:No effect on survival of treated rats were observed as compared to control. Clinical signs: When treated with 25 mg/kg bw/day, discoloration (pink or reddish) of the urine were observed in treated male and female rats as compared to control.Body weight:No effect on body weight of treated rats was observed as compared to control. Food consumption:No effect on food consumption of treated rats was observed as compared to control. Reproductive performance:No effect on fertility indices, gestation anomalies, viability and survival of the pups were observed in treated rats as compared to control.Histopathology:No histopathological changes were observed intreated rats as compared to control.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effectsDetails on embryotoxic / teratogenic effects:Mortality:No effect on survival of treated F1 and F2 pups were observed as compared to control. Clinical signs: When treated with 25 mg/kg bw/day, discoloration (pink or reddish) of the urine were observed in F1 and F2 treated male and female pups as compared to control.Body weight: No effect on body weight of F1 and F2 treated male and female pups were observed as compared to control.Food consumption:No effect on food consumption of treated F1 and F2 rats were observed as compared to control. Reproductive performance: No effect on fertility indices, gestation anomalies, viability and survival of the pups were observed in treated rats as compared to control.Histopathology:In F2a generation, 1 pup had exencephaly, spina bifida and great vessel anomalies which was considered an incidental finding.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 25 mg/kg bw/day for F0, F1 and F2 generation when Charles River COBS CD (Sprague Dawley) male and female rats were treated wtih D&C Red 33.
- Executive summary:
In a Multigeneration Study,Charles River COBS CD (Sprague Dawley) male and female rats were treated wtih D&C Red 33 in the concentration of 0, 0.25, 2.5, 7.5 and 25.0 mg/kg bw/day orally in deit. No effect on survival of F0, F1 and F2 generation were observed. Discoloration (pink or reddish) of the urine were observed in F0, F1 and F2 treated male and female rats as compared to control. Similaly, no effect on body weight and food consumption of treated F0, F1 and F2 rats were observed as compared to control.No effect on fertility indices, gestation anomalies, viability and survival of the pups were observed in F0, F1 and F2 treated rats as compared to control. In addition no effect on histopathology of F0 and F1 treated rats were observed. In F2a generation, 1 pup had exencephaly, spina bifida and great vessel anomalies which was considered an incidental finding.Therefore,NOAEL was considered to be 25 mg/kg bw/day for F0, F1 and F2 generation when Charles River COBS CD (Sprague Dawley) male and female rats were treated wtih D&C Red 33.
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