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EC number: 240-005-7 | CAS number: 15876-39-8
- 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 of D&C Red No. 28 was performed in 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
- Purity: 95%
- 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 approx.
- 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: 56 male
- 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: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
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: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Data not available
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: Yes
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- 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: No data
- Time schedule for examinations: No data
- Dose groups that were examined: DNo data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- No data
- Other examinations:
- No data
- 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: Increase in body weight gain was observed in treated rats over the 14 days observation period. 8-week-old rats weighed 168 g±6 g and by 10 weeks they weighed 225 g±10 gAs there is no control in the study the effect were not supposed to be treatment related.
Food consumption : No data
Compound intake: Daily intake was found to 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 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
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect 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 of D&C Red No. 28 was performed in rats. Fischer-344 (F-344) male rats were treated with D&C Red No. 28 orally in diet in the concentration of 500 mg/kg/day. The animals were observed for changes in body weight and excretion of the dye in urine of treated animals. Increase in body weight gain was observed in treated rats over the 14 days observation period. 8-week-old rats weighed 168 g±6 g and by 10 weeks they weighed 225 g±10 g. As there is no control in the study the effect were not supposed to be treatment related. Daily intake was observed to be 500 mg/kg for 14 days. Therefore, the No Observed Adverse Effect 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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