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EC number: 204-337-6 | CAS number: 119-61-9
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline was followed but well documented scientifically defensible approach was used to conduct the study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
- Principles of method if other than guideline:
- A single dose of benzophenone was administered by intravenous injection or gavage to male and female F344/N rats. Concentrations of benzophenone were determined in plasma at timepoints up to 24 hours after dosing. The results were analyzed to establish basic toxicokinetic parameters.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzophenone
- EC Number:
- 204-337-6
- EC Name:
- Benzophenone
- Cas Number:
- 119-61-9
- Molecular formula:
- C13H10O
- IUPAC Name:
- benzophenone
- Details on test material:
- - Name of test material (as cited in study report): Benzophenone
- Source: Aldrich Chemical Company
- Lot. no.: 10803KG
- Purity: > 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic (Germantown, NY)
- Age at study initiation: 10 to 11 weeks old
- Housing: Individually in polycarbonate cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Quarentined period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 ºC (69-75° F)
- Humidity (%): 40-70%,
- Photoperiod (hrs dark / hrs light): 12:12 hour light/dark cycle
Administration / exposure
- Route of administration:
- other: intravenous and oral (gavage)
- Details on exposure:
- Dosing volume was 2 mL/kg by intravenous injection or 5 mL/kg by gavage
- Duration and frequency of treatment / exposure:
- A single intravenous injection or a single gavage administration.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Intravenous: 2.5 mg/kg body weight
Oral: 2.5, 5, or 10 mg/kg.
- No. of animals per sex per dose / concentration:
- Five rats per sex and per dose.
- Details on dosing and sampling:
- At specified times after dosing, rats were anesthetized with a mixture of carbon dioxide and oxygen. Blood samples were collected by retroorbital puncture from five male and five female per timepoint. Generally, two samples were taken from each rat (more than 2 hours apart), one from each eye. The samples were collected into heparinized microhematocrit tubes and the plasma was separated by centrifugation at 1000 × g for 10 minutes and then stored frozen until analysis using a validated method.
The times of blood sample collection after administration was as follows:
Intravenous: 4, 7, 10, 15, 30, 60, 90, 120, 180, 240, 360, 480, 960 minutes.
Oral: 2.5, 5, 7.5, 10, 15, 30, 60, 120, 180, 360, 480, 600, 960, 1440 minutes (the last sample only at 5 and 10 mg/kg bw groups). - Statistics:
- Plasma concentration data were analyzed by noncompartmental modeling techniques
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- There was a great deal of fluctuation in mean plasma benzophenone concentrations at later time points, with secondary increases observed after initial decreases at most of the doses tested, regardless of the route of administration. This variation in concentration in the terminal portion of the curve resulted in extrapolation of up to 31% of the area from the last observed time point to infinity making the accuracy of the AUC and bioavailability estimates uncertain.
- Details on excretion:
- Estimates of elimination rate constants and half-lives for males were similar for the intravenous and low gavage doses, with slight decreases in elimination rate constant and concomitant increases in half-lives at the two higher gavage doses. For female rats, estimates elimination rate constant and half-lives were similar for the three gavage doses. After intravenous administration to females elimination rate constants was slightly higher than after gavage administration, with a concomitant decrease in half-lives.
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- other: Elimination rate constant (see details below)
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 1st: (see details below)
- Test no.:
- #3
- Toxicokinetic parameters:
- AUC: (see details below)
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Bioavailability after a gavage dose ranged from 1.05 to 1.39 in females, with an average value of 1.18.
Any other information on results incl. tables
|
Dose |
K elim (min-1) |
T ½ elim (min) |
AUC (μgCmin/mL) |
AUC/Dose |
Bioavailability |
|
Male |
Intravenous |
2.5 |
0.00260 |
268 |
51.9 |
21.1 |
-- |
Gavage |
2.5 |
0.00280 |
245 |
32.7 |
17.4 |
0.824 |
|
Gavage |
5 |
0.00120 |
594 |
95.6 |
24.9 |
1.18 |
|
Gavage |
10 |
0.00140 |
506 |
208 |
26.7 |
1.27 |
|
Female |
Intravenous |
2.5 |
0.00280 |
247 |
51.6 |
20.6 |
-- |
Gavage |
2.5 |
0.00120 |
567 |
53.8 |
28.6 |
1.39 |
|
Gavage |
5 |
0.00180 |
395 |
86.8 |
22.7 |
1.10 |
|
Gavage |
10 |
0.00140 |
499 |
166 |
21.6 |
1.05 |
K elim = elimination rate constant
T 1/2 elim = half-life
AUC = aera under the plasma concentration versus time curve
Applicant's summary and conclusion
- Conclusions:
- The plasma elimination half-life of benzophenone in rats was approximately 4 hours after intravenous injection and 8 hours after administration by gavage in corn oil.
- Executive summary:
A single dose of benzophenone was administered by intravenous injection or gavage to male and female F344/N rats. Concentrations of benzophenone were determined in plasma at timepoints up to 24 hours after dosing. The results were analyzed to establish basic toxicokinetic parameters. Plasma concentrations of the parent compound were determined following oral and intravenous administration of benzophenone. The plasma concentration of benzophenone versus time plots showed secondary maxima, apparently due to enterohepatic circulation. The data were analyzed by noncompartmental modeling and indicated no consistent sex-related or exposure-related effects. There was a great deal of fluctuation in mean plasma benzophenone concentrations at later time points, with secondary increases observed after initial decreases at most of the doses tested, regardless of the route of administration. Estimates of elimination rate constants and half-lives for males were similar for the intravenous and low gavage doses, with slight decreases in elimination rate constant and concomitant increases in half-lives (k.elim ca. 0.00270/min; t1/2 ca. 255 min) at the two higher gavage doses. For female rats, estimates elimination rate constant and half-lives were similar for the three gavage doses (k.elim ca. 0.00280/min; t1/2 ca. 247 min) . After intravenous administration to females elimination rate constants was slightly higher than after gavage administration, with a concomitant decrease in half-lives. Bioavailability after a gavage dose ranged from 1.05 to 1.39 in females, with an average value of 1.18.
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