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EC number: 282-941-9 | CAS number: 84473-86-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Absorption and elimination of D&C Red No. 28 in male F-344 rats
- Author:
- C.J. Sweeta, A.M. So´ lyoma, I.G. Sipesb,*
- Year:
- 2 004
- Bibliographic source:
- Food and Chemical Toxicology 42 (2004) 641–648
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Repeated dose oral toxicity study was performed to determine the toxic nature of D&C Red No. 28 using rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- EC Number:
- 242-355-6
- EC Name:
- 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid
- Cas Number:
- 18472-87-2
- Molecular formula:
- C20H4Br4Cl4O5.2Na
- IUPAC Name:
- 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
- Reference substance name:
- D&C Red No. 28
- IUPAC Name:
- D&C Red No. 28
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: D&C Red No. 28
- Molecular formula: 20H2Br4Cl4O5Na2
- Molecular weight: 829.66 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): 5 %
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material: D&C Red No. 28
- IUPAC name: 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
- Molecular formula: 20H2Br4Cl4O5Na2
- Molecular weight: 829.66 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): 5 %
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague–Dawley Inc. (Indianapolis, IN).
- Age at study initiation: 8-week-old
- Weight at study initiation: 168 ± 6 g
- Fasting period before study: No data available
- Housing: Animals were housed in individual Nalgene metabolism cages or wire hanging cages.
- Diet (e.g. ad libitum): Teklad 4% Mouse-Rat Diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: 5–7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 23.33 °C
- Humidity (%): 40-60%
- Air changes (per hr): 15 fresh filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Blended rat chow (Teklad 4% Mouse-Rat Diet)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Diet was prepared by blending rat chow (Teklad 4% Mouse-Rat Diet) mixed with Red 28 for 14 days such that their daily intake would be 500 mg/kg.
DIET PREPARATION
- Rate of preparation of diet (frequency): Every three days
- Mixing appropriate amounts with (Type of food): Blending rat chow (Teklad 4% Mouse-Rat Diet)
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): blending rat chow (Teklad 4% Mouse-Rat Diet)
- Concentration in vehicle: 500 mg/kg/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 analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500 mg/kg/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 500 mg/kg: Two groups each of 28 male rats
- Control animals:
- not specified
- Details on study design:
- Data not available
- Positive control:
- Data not available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Data not available
- Time schedule: Data not available
- Cage side observations checked in table [No.?] were included. Data not available
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Data not available
BODY WEIGHT: Yes
- Time schedule for examinations: Every other day
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: Data not 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: Data not available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Data not available
- Time schedule for examinations: Data not available
OPHTHALMOSCOPIC EXAMINATION: Data not available
- Time schedule for examinations: Data not available
- Dose groups that were examined: Data not available
HAEMATOLOGY: Data not available
- Time schedule for collection of blood: Data not available
- Anaesthetic used for blood collection: Data not available
- Animals fasted: Data not available
- How many animals: Data not available
- Parameters checked in table [No.?] were examined. Data not available
CLINICAL CHEMISTRY: Data not available
- Time schedule for collection of blood: Data not available
- Animals fasted: Data not available
- How many animals: Data not available
- Parameters checked in table [No.?] were examined. Data not available
URINALYSIS: Yes
- Time schedule for collection of urine: Data not available
- Metabolism cages used for collection of urine: Data not available
- Animals fasted: Yes, for 24 hours
- Parameters checked in table [No.?] were examined. Presence of D&C Red No. 28 in urine were examined.
NEUROBEHAVIOURAL EXAMINATION: Data not available
- Time schedule for examinations: Data not available
- Dose groups that were examined: Data not available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Data not available
OTHER: Data not available - Sacrifice and pathology:
- No data
- Other examinations:
- To determine plasma kinetics and background levels of Red 28 from the diet, four rats from each group were killed by CO2 inhalation at 1, 2, 4, 8, 12, 24 and 48 h post dosing.
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Mortality: No data
Clinical signs: No data
Body weight and weight gain : An increase in body weight gain was observed in treated rats over the 14 days study period. 8-week-old rats at the start of the study weiged 168 g±6 g and by 10 weeks they weighed 225 g±10 g.
As there is no control in the study, the effects were not supposed to be treatment related.
Food consumption: No data
Compound intake: Daily intake would be 500 mg/kg for 14 days
.
Food efficiency: No data
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology : No data
Clinical chemistry: No data
Urinanalysis: No Red 28 dye was detected in the urine or cage rinse of treated rats.
Neurobehaviour: No data
Organ weights: No data
Gross pathology: No data
Histopathology: No data
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effect on body weight
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Detectable plasma levels of Red 28 were not present in the animals that received the bolus dose of water following pretreatment with Red 28 in the diet. In the animals that received the bolus dose of Red 28, the average maximum concentration of Red 28 measured in the plasma was 2.2 nmol/ml (0.01% of the bolus dose in total plasma volume). Red 28 was not detected in plasma beyond 12 h post dosing. The terminal half-life was calculated to be 1.7 h with a terminal rate constant of 0.41 h-1. Oral bioavailability of Red 28 was determined to be 0.60%.
Following a 14-day pretreatment regimen with Red 28 in the diet, animals that received the bolus dose of the vehicle (i.e., no Red 28) on day fifteen still excreted dye in the feces 24 h after being placed on the control diet. The amount of Red 28 recovered was 24501020 nmol/ g feces. The amount of dye recovered in the feces from these animals during the next 24 h declined dramatically (4648 nmol/g). As occurred with naı¨ve animals administered a large oral bolus dose of Red 28, animals that had been pretreated for 14 days developed diarrhea when administered the large bolus dose (500 mg/kg) by oral gavage.
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effdect level (NOAEL) was considered to be 500 mg/kg/day when Fischer-344 (F-344) male rats were treated with D&C Red No. 28
- Executive summary:
Repeated dose oral toxicity study was performed to determine the toxic nature of D&C Red No. 28 using rats. Two groups of 8 week old 28 male Fischer-344 rats each were fed a diet containing blended rat chow (Teklad 4% Mouse-Rat Diet) mixed with Red 28 for 14 days such that their daily intake would be 500 mg/kg. Rats were weighed every other day. Food containers were also weighed every day to determine the amount of consumed diet. The diet was prepared and replaced every three days based on the actual food consumption and weight of the animals over the two-week period. On day 15, after a 12 h fasting period, one group was dosed by oral gavage with the dye (500 mg/kg; 2 ml/kg) in water while the other group was dosed with the vehicle (water, 2 ml/kg). To determine plasma kinetics and background levels of Red 28 from the diet, four rats from each group were killed by CO2 inhalation at 1, 2, 4, 8, 12, 24 and 48 h post dosing. At these times, blood (4–5 ml) was immediately collected from the posterior vena cava into a heparinized syringe and processed. An increase in body weight gain was observed in treated rats over the 14 days study period. 8-week-old rats at the start of the study weiged 168 g±6 g and by 10 weeks they weighed 225 g±10 g. As no control animals were included in the study, the effects were not supposed to be treatment related. No Red 28 dye was detected in the urine or cage rinse of treated rats. Based on the observations made, the No Observed Adverse Effdect level (NOAEL) was considered to be 500 mg/kg/day when Fischer-344 (F-344) male rats were treated with D&C Red No. 28.
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