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EC number: 701-337-2 | CAS number: -
- 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:
- 10 August 1994 - 27 September 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study was conducted under GLP conditions but not according to a guideline. However, overall results were reported well and study design seems appropriate. The report does not provide very detailed results: individual data tables and data on sample concentrations is missing.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- publication
- Title:
- Comparative metabolism and toxicokinetics of 14C-Resorcinol bis-diphenylphosphate (RDP) in the rat, mouse, and monkey
- Author:
- Freudenthal, R.I., McDonald, L.J., Johnson, J.V., McCormick. D.L., Henrich, R.T.
- Year:
- 2 000
- Bibliographic source:
- International Journal of Toxicology, 19, 233-242
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- Mice experiments: 1. Excretion after intravenous injection 2. Pharmacokinetics after intravenous injection
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- EC Number:
- 701-337-2
- Cas Number:
- not available
- Molecular formula:
- C30H24O8P2
- IUPAC Name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report):
Non-radiolabeled Resorcinol diphenyl phosphate
14C-radiolabeled RDP
- Physical state:
Non-radiolabeled Resorcinol diphenyl phosphate: Solid
14C-radiolabeled RDP: Liquid
- Lot/batch No.: Confidential information
- Radiochemical purity (if radiolabelling): 96.7%
- Storage condition of test material: In glass vials with teflon caps, at 4 degrees Celsius
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation:
Males: approx. 9 weeks
Females: approx. 12 weeks
- Weight at study initiation:
Excretion experiment:
Males: 23-26.2 g
Females: 21.6-23.5 g
Pharmacokinetics experiment:
Males: 21.2-28.3 g
Females: 20.8-25.7 g
- Housing: under standard conditions
- Individual metabolism cages (metabolism cage with outlets with CO2 traps):
Excretion experiment: no (groups of 4)
Pharmacokinetic experiment: yes
- Diet (e.g. ad libitum): Ad libitum, rodent chow
- Water (e.g. ad libitum): Ad libitum, municipal water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- ethanol
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
14C-RDP was mixed with non-radiolabeled RDP in an ethanol vehicle to obtain a target concentration of 100 mg RDP/ml.
This concentration was used in both the excretion and pharmacokinetics experiment in mice. - Duration and frequency of treatment / exposure:
- Single intravenous injection in tail vein (1 ml/kg)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw (50 uCi)
- No. of animals per sex per dose / concentration:
- Excretion experiment: 8 (1 group)
Pharmacokinetics experiment: 3 (17 groups) - Control animals:
- no
- Positive control reference chemical:
- Not relevant
- Details on study design:
- OBSERVATIONS
Mortality, clinical evidence of toxicity: at least once daily
Analysis of samples was performed as follows:
- Plasma: Quantification of RDP performed by measurement of 14C radioactivity by liquid scintillation spectroscopy (duplicate samples)
- Urine: Aliquots were analysed for radioactivity by scintillation counting (in duplicate)
- Faeces: Samples were oxidized and the gas produced was bubbled into vials containing a liquid cocktail. The radioactivity was then counted by liquid scintillation counting (duplicate samples) - Details on dosing and sampling:
- EXCRETION EXPERIMENT
- Tissues and body fluids sampled: urine (including cage wash), faeces, expired air
- Time and frequency of sampling:
Urine/faeces: 2, 6, 12, 24 hours, 2, 3, 4, 5, 6, 7 days after dosing according to protocol. Final time point reported in results: 14 days
Expired air: On alternate days
PHARMACOKINETIC EXPERIMENT
- Tissues and body fluids sampled: blood (pooled per 3 mice/timepoint/sex)
- Time and frequency of sampling: 5, 15, 30, 60 minutes, 2, 4, 8, 12, 24 hours, 2, 3, 4, 5, 6, 7, 10, 14 days - Statistics:
- - Goodness of Fit analysis
- 2 tailed t-test: comparison between sexes
- ANOVA: for species and route comparisons (if significant, additionally Tukey HSD post-hoc multiple comparison test)
Results and discussion
- Preliminary studies:
- Not relevant
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not relevant
- Details on distribution in tissues:
- Not relevant
- Details on excretion:
- Final time point (14 days): mean values male (n=1) + males (n=2) (similar pattern between sexes)
- Urine: 25.03%
- Faeces: 46.14%
- Expired air: 1.66%
Total recovery: 72.83%
Toxicokinetic parametersopen allclose all
- Test no.:
- #2
- Toxicokinetic parameters:
- Cmax: 15.51 ug equivalents/ml plasma
- Test no.:
- #2
- Toxicokinetic parameters:
- Tmax: 5 min.
- Test no.:
- #2
- Toxicokinetic parameters:
- AUC: 908 ug equiv*hr/ml
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 1st: 7.61 days
- Test no.:
- #2
- Toxicokinetic parameters:
- other: MRT: 10.93 days
- Test no.:
- #2
- Toxicokinetic parameters:
- other: V: 19.80 L/kg
- Test no.:
- #2
- Toxicokinetic parameters:
- other: Cl: 0.35 L/hr/kg
- Test no.:
- #2
- Toxicokinetic parameters:
- other: Vss: 92.60 L/kg
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- Not relevant
Any other information on results incl. tables
Mortality and clinical observations excretion experiment:
- 4 animals of one cage died due to asphyxiation
- No clinical evidence of toxicity associated with exposure to test substance
Mortality and clinical observations pharmacokinetics experiment:
- Four mice died during dosing and were replaced. Mortality was associated with ethanol vehicle
- No clinical evidence of toxicity associated with exposure to test substance
Doses excretion experiment:
- Males received 114.2 +/- 10.8 mg RDP/kg bw and 60.3 +/- 5.9 uCi/animal
- Females received 107.4 +/- 5.9 mg RDP/kg bw and 52.6 +/- 2.3 uCi/animal
- Combined: 110.8 +/- 9.1 mg RDP/kg bw and 56.4 +/- 5.9 uCi/animal
Doses pharmacokinetics experiment:
- Males received 100.5 +/- 5.7 mg RDP/kg bw and 54.8 +/- 0.0 uCi/animal
- Females received 105.0 +/- 6.7 mg RDP/kg bw and 52.7 +/- 2.4 uCi/animal
- Combined: 102.8 +/- 6.6 mg RDP/kg bw and 53.7 +/- 2.0 uCi/animal
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the primary route of excretion for the mouse was via the faeces.
- Executive summary:
The study was conducted to determine the disposition of 14C-labelled RDP administered by intravenous injection in B6C3F1 mice. The experiments consisted of an excretion (8 animals/sex/group) and pharmacokinetics experiment (3 animals/sex/group) after intravenous injection. A dose of 100 mg/kg bw was administered, with an aimed radioactivity of 50 uCi.
No treatment related mortality and clinical signs were noted during the experiments. The actual dose was slightly higher than the aimed dose (100 mg RDP/kg bw), but some variation was apparent (SD: 5.7 -10.8 mg RDP/kg bw). After 14 days 25% of the dose was excreted in urine, while 46% was excreted in the faeces. Excreted dose in expired air was approximately 2 %. Total recovery was approximately 73%. Kinetic parameters were: Cmax: 15.51 ug equivalents/ml plasma, Tmax: 5 min, AUC: 908 ug/equivalents*hr/ml, half-life: 7.61 days, MRT: 10.93 days, V: 19.80 L/kg, Cl: 0.35 L/hr/kg and Vss: 92.60 L/kg. These data could be accurately described by a two-compartment model.
Under the conditions of this study, the primary route of excretion for the mouse after intravenous exposure was via the faeces.
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