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EC number: 201-245-8 | CAS number: 80-05-7 Bisphenol A; BPA
- 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
- 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:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Research Conducted by the National Toxicology Program (Research Triangle Park, NC) with Participation from FDA (Jefferson, AR)
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmacokinetics of bisphenol A in humans following a single oral administration.
- Author:
- Thayer, K. A., Doerge, D. R., Hunt, D., Schurman, S. H., Twaddle, N. C., Churchwell, M. I., Garantziotis, S., Kissling, G. E., Easterling, M. R., Bucher, J. R., and Birnbaum, L. S.
- Year:
- 2 015
- Bibliographic source:
- Environment International. 83:107-115.
Materials and methods
- Objective of study:
- absorption
- excretion
- metabolism
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Six men and eight women were exposed to 100 μg/kg bw of deuterated Bisphenol A (d6-BPA) by oral administration and blood and urine analysis were conducted over a three day period. The use of d6-BPA allowed administered d6-BPA to be distinguished from background native (unlabeled) Bisphenol A. The following parameters are reported: rate of oral absorption, serum elimination, half-life, area under the curve (AUC), urinary excretion, and metabolism to glucuronide and sulfate conjugates."
- GLP compliance:
- not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- not specified
- Details on test material:
- A single dosing solution (10 mg/mL) was prepared by dissolving d6-BPA in absolute ethanol (USP grade, Decon Laboratories, King of Prussia, PA). Aliquots of 0.5 and 1 mL were placed in sealed screw-top glass vials, and stored chilled until just before dosing. The initial concentration of d6-BPA in the dosing solution (10 μg/μL) was verified by LC/MS/MS and concentrations in stored aliquots were always within 10 % of the initial amount (range 93–106 %).
- Radiolabelling:
- other: deuterated BPA (d6-BPA)
Test animals
- Species:
- human
- Strain:
- other: Men and non-pregnant women were recruited in 2012–2013 from the Raleigh Durham region of North Carolina, USA.
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: Subjects were fed a vanilla wafer cookie containing a dose of 100 μg/kg bw of d6-Bisphenol A after fasting starting at 12 midnight on the day of the visit.
- Vehicle:
- other: A single dosing solution (10 mg/ml) was prepared by dissolving d6-Bisphenol A in absolute ethanol. Aliquots of 0.5 and 1 ml were placed in sealed screw-top glass vials, and stored chilled until just before dosing.
- Duration and frequency of treatment / exposure:
- Single treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 µg/kg
- No. of animals per sex per dose:
- six men and eight women
- Control animals:
- no
Results and discussion
Main ADME resultsopen allclose all
- Type:
- other: Mean serum total (unconjugated and conjugated) d6-BPA Cmax of 1711 nM (390 ng/ml) was observed at Tmax of 1.1 ± 0.50 h.
- Results:
- Unconjugated d6-BPA appeared in serum within 5–20 min of dosing with a mean Cmax of 6.5 nM (1.5 ng/ml) observed at Tmax of 1.3 ± 0.52 h.
- Type:
- other: The half-times for terminal elimination of total d6-BPA and unconjugated d6-BPAwere 6.4±2.0 h and 6.2±2.6 h, respectively.
- Results:
- Recovery of total administered d6-BPA in urine was 84–109%. Most subjects (10 of 14) excreted >90% as metabolites within 24 h.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Main metabolite: Bisphenol A-glucuronide in addition Bisphenol A-sulfate was identified and bis-conjugates.
Any other information on results incl. tables
Mean serum total (unconjugated and conjugated) d6-BPA Cmax of 1711 nM (390 ng/ml) was observed at
Tmax of 1.1 ± 0.50 h. Unconjugated d6-BPA appeared in serum within 5–20 min of dosing with a mean Cmax of
6.5 nM (1.5 ng/ml) observed at Tmax of 1.3 ± 0.52 h. Detectable blood levels of unconjugated or total d6-BPA
were observed at 48 h in some subjects at concentrations near the LOD (0.001–0.002 ng/ml). The half-times
for terminal elimination of total d6-BPA and unconjugated d6-BPAwere 6.4±2.0 h and 6.2±2.6 h, respectively.
Recovery of total administered d6-BPA in urine was 84–109%. Most subjects (10 of 14) excreted >90% as metabolites
within 24 h.
Applicant's summary and conclusion
- Executive summary:
"Conclusions: Using more sensitive methods, our study expands the findings of other human oral pharmacokinetic studies. Conjugation reactions are rapid and nearly complete with unconjugated Bisphenol A comprising less than 1% of the total d6-Bisphenol A in blood at all times. Elimination of conjugates into urine largely occurs within 24 h."
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