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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- 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 rat feeding study, exposure beginning in utero
- 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 -12
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Combined repeated dose repro-devp. Screen 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): 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic acid (disodium salt) < 0.3%, 4,5-Dihydroxy-3-(phenylazo)-2,7-naphthalenedisulfonic acid (disodium salt) < 3%, 4-Aminoazobenzene < 100 ppb, 4-Aminobiphenyl < 275 ppb, Aniline < 25 ppm, Azobenzene < 1 ppm, ,Benzidine < 20 ppb, 1,3-Diphenyltriazene < 125 ppb, Heavy Metal Content, Antimony, Arsenic, Mercury < 5 ppm, Cadmium < 10 ppm and Lead < 20 ppm
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet
- Details on oral 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): No data available - Storage temperature of food: No data available VEHICLE- Justification for use and choice of vehicle (if other than water): No data available - Concentration in vehicle: 0, 12, 25, and 102 mg/kg bw/day for male and 0, 15, 31, and 129 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
- Duration of treatment / exposure:
- 24 months
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 12, 25, and 102 mg/kg bw/day for male and 0, 15, 31, and 129 mg/kg bw/day for female Basis:actual ingested
- No. of animals per sex per dose:
- Total: 600 0 mg/kg bw/day: 120 male, 120 female 12 and 15 mg/kg bw/day: 60 male, 60 female25 and 31 mg/kg bw/day: 60 male, 60 female102 and 129 mg/kg bw/day: 60 male, 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 - Cage side observations checked in table [No.?] were included: Morbidity and mortality were observed DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: Daily BODY WEIGHT: Yes - Time schedule for examinations: Weekly throughout the in utero segment weekly for the first 14 weeks, biweekly (the second7 days of every two weeks) the next 12 weeks and once monthly (7 days during the third week of each month) thereafter for the post-weaning segment of the study.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: No data available - 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 WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available - Time schedule for examinations: No data available OPHTHALMOSCOPIC EXAMINATION: Yes - Time schedule for examinations: At week 16 of the in utero segment, during week 1 and months 3, 6, 12, 18 and 24 of the post-weaning segment of the study. - Dose groups that were examined: All rats were examined. HAEMATOLOGY: Yes - Time schedule for collection of blood: At 3, 6, 12, 18 and 24 months of study - Anaesthetic used for blood collection: No data available - Animals fasted: No data available - How many animals: 10 rats/sex/group - Parameters checked in table [No.?] were examined. No data available CLINICAL CHEMISTRY: Yes - Time schedule for collection of blood: At 3, 6, 12, 18 and 24 months of study - Anaesthetic used for blood collection: No data available - Animals fasted: No data available - How many animals: 10 rats/sex/group - Parameters checked in table [No.?] were examined. No data available URINALYSIS: Yes - Time schedule for collection of urine: at3, 6 and 12 months- 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: Yes Interim sacrifice and necropsy of 10 rats/sex/group were conducted following 12 months of compound administration.HISTOPATHOLOGY: Yes
- Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- Mortality: No effect on survival of treated rats were observed as compared to control. Clinical signs: Differences in the colour of urine, faeces, hair or exposed skin areas were observed in treated rats as compared to control. Body weight and weight gain: No effect on body weight were observed in treated rats as compared to control. Food consumption and compound intake: No effect on food comsumption were observed in treated rats as compared to control. Compound intake: : Dosage levels of 0.025, 0.05 and 0.2% is corresponded to 12, 25, and 102 mg/kg bw/d for males and 15, 31, and 129 mg/kg bw/d for females. Food efficiency: No data availableWater consumption and compound intake: No effect on water consumption were observed in treated rats as compared to control. Opthalmoscopic examinationNo effect on opthalmoscopic examination were observed in treated rats as compared to control. Haematology: No effect on hematological examination were observed in treated rats as compared to control. Clinical chemistry: No effect on Clinical chemistry of treated were observed as compared to control. Urinanalysis: When treated with 102 and 129 mg/kgbw/day, orange to red discoloration of the urine at 18 months and light-red colour of urine were observed other than colour, no differences were observed in treated rats as compared to control. Neurobehaviour: No data availableOrgan weightsNo data availableGross pathology: No effect on gross pathology of treated were observed as compared to control. Histopathology: No histopathological changes were observed in treated rats as compared to control.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 102 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effect on survival, clinical sign, body weight, food consumption, Ophthalmoscopy, hematology, clinical chemistry, gross pathology and histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 129 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effect on survival, clinical sign, body weight, food consumption, Ophthalmoscopy, hematology, clinical chemistry, gross pathology and histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 102 mg/kg bw/day for male and 129 mg/kg bw/day for female rats when male and female rats were treated with D&C Red 33.
- Executive summary:
In a Combined repeated dose repro-devp. Screen,male and female rats were treated with D&C Red 33 in the concentration of 0, 12, 25, and 102 mg/kg bw/day for male and 0,15, 31, and 129 mg/kg bw/day for femaleorally in diet. No effect were observed on survival of treated rats. differences in thecolour of urine, faeces, hair or exposed skin areas were observed in treated rats as compared to control. No effect were observed on body weight, food consumption and water consumption of treated rats as compared to control. Similarly, No effect on opthalmoscopic examination, hematology and Clinical chemistry of treated rats were observed as compared to control. In addition, no gross pathological and histopathological changes were observed in treated rats as conpared to control. Therefore,NOAEL was considered to be 102 mg/kg bw/day for male and 129 mg/kg bw/day for female rats when male and female rats were treated with D&C Red 33 orally for 24 months.
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