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EC number: 284-366-9 | CAS number: 84852-53-9
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 2002 to Dec 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed using commercial SAYTEX 8010 Flame Retardant commercial product and 14C-labelled decabromodiphenyl ethane by a laboratory skilled in PK studies and according to GLPs
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
- Objective of study:
- other: ababsorption, distribution, metabolism, elimination
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.7485 (Metabolism and Pharmacokinetics)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]
- EC Number:
- 284-366-9
- EC Name:
- 1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]
- Cas Number:
- 84852-53-9
- Molecular formula:
- C14H4Br10
- IUPAC Name:
- 1,2,3,4,5-pentabromo-6-[2-(2,3,4,5,6-pentabromophenyl)ethyl]benzene
- Details on test material:
- 14C-decabromodiphenyl ethane (DBDPEthane) synthesized by Perkin Elmer LIfe Sciences, Inc (Boston, MA); specific activity: 21.63 uCi/mg; radiochemical purity 97.4% by HPLC.
Unlabeled DBDPEthane supplied by the Sponsor (Albemarle Corporation) as the commercial flame retardant product.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-ring labelled
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Rats,8 wks of age, were obtained from Charles River Laboratories, Portage, MI. Group 1 rats were not cannulated. Group 2 rats were received with surgically implanted jugular vein cannulas, and Group 3 with both jugular and bile duct cannulas. The animals were acclimated for 48 hrs only due to the implants. Each animal was identified by ear tages. Housed in environmentally controlled rooms, 12/12 light cycle, 63-78 degrees F and 30 to 64% humidity. Rats in the PK phase were housed in polycarbonate cages; rats in the excretion and bile phases were housed in polycarbonate metabolism cages. Harlan Teklad Certified Global 18% Protein Rodent Diet was offered ad libitum. Tap was provided ad libitum. Rats were fasted overnight prior to test article administration.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- Once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw; 50 uCi/kg
- No. of animals per sex per dose / concentration:
- 6 M/group
- Control animals:
- no
- Positive control reference chemical:
- No
- Details on study design:
- See below
- Details on dosing and sampling:
- GROUP 1, METABOLISM CAGES:
Urine and Cage Rinse Collections: 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 hr post-dosing
Feces Collections: 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hr post-dosing
GROUP 2, JUGULAR CATH:
Blood collections (0.25 ml) pre-dose, 15 and 30 minutes, and 1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168 hr post-dosing
GROUP 3, JUGULAR AND BILE CATH:
Blood Collections: pre-dose, 30 min, 6, 12, 24, 48 hr post-dosing
Bile Collection: 0-6, 6-12, 12-24, 24-48 hr post-dosing - Statistics:
- Samples were considered to be below the limit of detection when the corrected dpm value (gross dpm - background dpm) was less than twice the mean background value for each group of samples counted. These samples were indicated as NT (not detected) and treated as zero in any calculations.
Results and discussion
- Preliminary studies:
- See other information on materials and methods.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The absorption, distribution, metabolism and elimination of DBDPEthane (1000 mg/kg; 50 uCi/kg) were studied in Sprague-Dawley rats following a single oral dose of 14C-DBDPEthane. No 14C-activity was detectable in the plasma, bile or urine of treated rats at any time point (up to 168 hours post-dosing).
- Details on distribution in tissues:
- No 14C-activity was detectable in the plasma, bile or urine of treated rats at any time point (up to 168 hours post-dosing).
- Details on excretion:
- No 14C-activity was detectable in the plasma, bile or urine of treated rats at any time point (up to 168 hours post-dosing). A mass balance could not be determined because the presence of the test article in the feces prevented combustion and subsequent quantitation of 14C-CO2. Levels of 14C-activity in plasma, bile, urine and cage rinses were below the limit of detection in all samples.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- All samples analyzed by LSC were found to be below the limit of detection. Therefore, it was not possible to perform HPLC radiometabolite analyses or calculate pharmacokinetic parameters.
Any other information on results incl. tables
Levels of 14C-activity in plasma, bile, urine and cage rinses were below the limit of detection in all samples at all time points. A mass balance could not be determined, because the presence of the test article in the feces prevented combustion and subsequent quantitation of 14C-CO2. Based on the absence of 14C-activity in plasma, bile, urine and cage rinses and noncombustability of the feces, the majority of the administered dose was not recovered and indicates that the test article was not orally absorbed and therefore excreted in the feces.
In conclusion, a single oral dose of 14C-decabromodiphenyl ethane (1000 mg/kg) to bile duct- and jugular vein-cannulated male Sprague Dawley rats was very poorly, if at all, absorbed from the gastrointestinal tract, and subsequently eliminated in the feces (based on the inability to combust feces at extreme temperatures). No or negligible absorption is consistent with the test article’s poor solubility and high molecular weight.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
DBDPEthane was very poorly, if at all, absorbed from the gastrointestinal tract, and was subsequently eliminated in the feces. No or negligible absorption is consistent with the poor solubiltiy and high molecular weight of the test article and with the in vitro results reported in "Basic toxicokineicts #2". - Executive summary:
The absorption, distribution, metabolism and elimination of DBDPEthane (1000 mg/kg; 50 uCi/kg) were studied in Sprague-Dawley rats following a single oral dose of14C-DBDPEthane. No14C-activity was detectable in the plasma, bile or urine of treated rats at any time point (up to 168 hours post-dosing). A mass balance could not be determined because the presence of the test article in the feces prevented combustion and subsequent quantitation of14C-CO2; however, levels of14C-activity in plasma, bile, urine and cage rinses were below the limit of detection in all samples. Based on the absence of14C-activity in these samples, the majority of the administered dose was not recovered and indicates that the test article was not orally absorbed and therefore excreted in the feces. Decabromodiphenyl etthanewas very poorly, if at all, absorbed from the gastrointestinal tract, and was subsequently eliminated in the feces. No or negligible absorption is consistent with the poor solubility and high molecular weight of the test article. Based on these results, the substance does not have bioaccumulation potential.
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