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Diss Factsheets
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EC number: 201-236-9 | CAS number: 79-94-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well designed and performed study reported in the peer-reviewed literature. Not GLP or specific testing guidelines
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Objective of study:
- other: other: Determine systemic bioavailability after oral adminstration in rats; disposition in humans
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- other: rat, human
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 6 male rats; 3 male and 2 female human volunteers
Administration / exposure
- Route of administration:
- other: oral gavage (rat); gel capsule (human)
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- Rats: single oral gavage dose of 300 mg/kg bw, dose volume of 3.2 ml
Humans: single gel capsule orally, 0.1 mg/kg bw
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Rats: single oral gavage dose of 300 mg/kg bw, dose volume of 3.2 ml
Humans: single gel capsule orally, 0.1 mg/kg bw
- No. of animals per sex per dose / concentration:
- 6 male rats
3 human males; 2 human females - Control animals:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- metabolism
- Results:
- Metabolized mainly to sulfate conjugates in the rat, and to glucuronide conjugates in humans.
- Type:
- excretion
- Results:
- Rats: fecal excretion of unchanged TBBPA (>80% dose), trace amounts of sulfate-congugate in urine; Human: <0.1% dose in urine; feces not collected
- Type:
- distribution
- Results:
- Rats: TBBPA-sulfate main form in plasma followed by TBBPA and trace amounts of TBBPA-glucuronide ; Humans: TBBPA not detected in plasma, TBBPA-glucuronide was circulating form; trace amounts of TBBPA-sulfate in blood
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- Results in rats indicate sulfate and glucuronide conjugates are cleaved in the feces to the parent molecule.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Rats: primarily TBBPA-sulfate
Humans: primarily TBBPA-glucuronide
Trace amounts of the disulfate and diglucuronide and/or tribombisphenol A conjugates
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
TBBPA is rapidly metabolized and eliminated as glucuronide and/or sulfate conjugates by humans and rats, such that its systemic bioavailability is low. The conjugate(s) is/are the circulating form of TBBPA in blood - Executive summary:
This study reports the characterization of the toxicokinetics of TBBPA in human subjects and in rats. A single oral dose of 0.1 mg/kg TBBPA was administered to five human subjects. Rats were administered a single oral dose of 300 mg TBBPA/kg body weight. Urine and blood concentrations of TBBPA and its metabolites were determined by LC/MS-MS. TBBPA-glucuronide and TBBPA-sulfate were identified as metabolites of TBBPA in blood and urine of the human subjects and rats. In blood, TBBPA-glucuronide was detected in all human subjects, whereas TBBPA-sulfate was only present in blood from two individuals. Maximum plasma concentrations of TBBPA-glucuronide (16 nmol/l) were obtained within 4 h after administration. In two individuals where TBBPA-sulfate was present in blood, maximum concentrations were obtained at the 4-h sampling point; the concentrations rapidly declined to reach the limit of detection (LOD) after 8 h. Parent TBBPA was not present in detectable concentrations in any of the human plasma samples. TBBPA-glucuronide was slowly eliminated in urine to reach the LOD 124 h after administration. In rats, TBBPA-glucuronide and TBBPA-sulfate were also the major metabolites of TBBPA present in blood; in addition, a diglucuronide of TBBPA, a mixed glucuronide-sulfate conjugate of TBBPA, tribromobisphenol A, and the glucuronide of tribromobisphenol A were also present in low concentrations. TBBPA plasma concentrations peaked at 103 μmol/l 3 h after administration and thereafter declined with a half-life of 13 h; maximal concentrations of TBBPA-glucuronide (25 μmol/l) were also observed 3 h after administration. Peak plasma concentrations of TBBPA-sulfate (694 μmol/l) were reached within 6 h after administration. In conclusion, TBBPA is rapidly metabolized after absorption by conjugation resulting in a low systemic bioavailability of TBBPA.
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