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EC number: 251-118-6 | CAS number: 32588-76-4
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was performed by an experienced laboratory using 14C-radiolabel. Adequate detail on the study is provided in the report. Chemical and radiochemical purity of the test material were not provided. Total 14C-activity was determined in tissues and excreta.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
- Objective of study:
- other: To study excretion and tissue distribution in rats
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Corn oil suspensions were administered to rats by gavage once daily for 14 d. Urine, feces, expired air and organs collected at intervals and assessed for 14C-activity.
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
- EC Number:
- 251-118-6
- EC Name:
- N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
- Cas Number:
- 32588-76-4
- Molecular formula:
- C18H4Br8N2O4
- IUPAC Name:
- N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
- Test material form:
- solid: crystalline
- Details on test material:
- 14C-ring labelled; specific activity = 10.0 mCi/mM or 2.30 x 10+4 dpm/microgram or 23,000 dpm/microg.
Radio-chemical purity not provided in report.
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- once daily for 14 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Suspensions = approximately 1 mg/mL corn oil; confirmed by 14C-activity (Liquid Scintillation Counting) before dose initiation and daily during dosing.
Dosing volume = 0.2 ml
Based on an initial body weight of 220 g, the 14C-administered to the five rats was equivalent to 0.67 mg/kg (3.52 x 10+6 dpm or 149 micrograms).
- No. of animals per sex per dose / concentration:
- See below
- Control animals:
- yes, concurrent no treatment
Results and discussion
Main ADME resultsopen allclose all
- Type:
- excretion
- Results:
- Excreted mainly in the feces, with some 14C-activity detected in urine.
- Type:
- distribution
- Results:
- 14C-activity detected in tissues taken for assay after 14 consecutive daily doses; highest concentrations found in liver and kidney. Dissipation of radioactivity occured in all tissues examined during the withdrawal period.
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- At the end of dosing, the tissues with the highest 14C-activity were liver (~0.39 ppm) and kidney (~0.32 ppm). Levels in both dropped rapidly (by ~50%) during the first 7 days of withdrawal, and continued to drop over the withdrawal period. Levels in muscle (~0.08 ppm), fat (~0.075 pm) and brain (~0.032 ppm) were substantially below that of the liver and kidney after 14 days of dosing. By day 14 of the withdrawal period, no 14C-activity was detected in fat. 14C-activity in the liver, kidney, muscle and brain continued to fall between 14 and 30 days of withdrawal, and were below 0.05 ppm by 30 days post-treatment. The highest level at 30 day post-treatment was found in the skeletal muscle (0.05 ppm).
- Details on excretion:
- The 14C-label was excreted primarily in the feces; ~65% of the total 14-day dose was recovered in the feces during the dosing period. Approximately 15% of the total 14-day dose was detected in the urine during the dosing period. Negligible 14C-activity was detected in expired air. Thus, 80% of the total dose was recovered in the feces and urine during the 14 days of dosing.
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
No abnormal behaivor detected during the study. All animals had normal weight gain. Organs normal on gross necropsy.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
- Executive summary:
14C-labelled EBTBP (~0.67 mg/kg) was administered to 5 female Sprague Dawley rats by gavage in corn oil for 14 consecutive days. Two additional female rats served as controls. Two animals were sacrificed 24 hr after the last dose, and the remainder sacrificed after 7, 14 and 30 days of withdrawal. Feces, urine and expired air were collected during the dosing period: One test animal sacrificed on day 14 was housed in a Roth metabolism cage to allow collection of expired C02, volatile organics, feces, and urine. The other animal sacrificed on day 14 was housed in a plastic metabolism cage to allow collection of feces and urine. Skeletal muscle, brain, kidney, liver and fat were collected at each sacrifice from all animals.
The14C-label was excreted primarily in the feces; ~65% of the total 14-day dose was recovered in the feces during the dosing period. Approximately 15% of the total 14-day dose was detected in the urine during the dosing period. Negligible14C-activity was detected in expired air. Thus, 80% of the total dose was recovered in the feces and urine during the 14 days of dosing.
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