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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
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity 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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: No data available - Age at study initiation: (P) x wks; (F1) x wks: No data available - Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g: 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 mating procedure:
- Details on study scheduleF0: 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 litters - 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 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.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 110 days and more
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 0.25, 2.5, 7.5 and 25.0 mg/kg bw/day Basis:
- 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
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Survival, clinical sign, Body weight and food consumption were examined.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- Survival, clinical sign, Body weight and food consumption were examined.
- Postmortem examinations (parental animals):
- Histopathology were examined.
- Postmortem examinations (offspring):
- Histopathology were examined.
- Statistics:
- No data available
- Reproductive indices:
- Fertility indices, gestation anomalies, viability and survival of the pups were examined.
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on survival, clinical sign, Body weight, food consumption, histopathology and reproductive parameters
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on survival, clinical sign, Body weight, food consumption, histopathology and reproductive parameters
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on survival, clinical sign, Body weight, food consumption, histopathology and reproductive parameters
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 25 mg/kg bw/day 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 F2treated rats as compared to control. In addition no effect on histopathology of F0 and F1 trated 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 when Charles River COBS CD (Sprague Dawley) male and female rats were treated wtih D&C Red 33.
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