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Diss Factsheets
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EC number: - | CAS number: 37486-69-4
- 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:
- 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
- Objective of study:
- absorption
- excretion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Custom toxicokinetic screening protocol
- Principles of method if other than guideline:
- Male rats (6) were adminitered a single 907 mg/kg dose of the test article via oral gavage. Serum (1, 6, 24, 48, 72, and 96 hours post-dose) and urine and feces (0-6, 6-24-24-48, 48-72, and 72-96 hours post-dose) samples were collected. Liver and subcutaneous fat samples were collected from control and treated animals at termination on Study Day 5. Serum, urine, feces and liver samples were analyzed for the parent compound.
- GLP compliance:
- no
Test material
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot TFEE5-276/12/09-1
- Purity test date: 10th February, 2011
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In its original contaner at room temperature, protected from light.
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, the test article was dosed as received. - Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- Sprague-Dawley [Crl;CD(SD)IGS BR]
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, MI
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 201-218 grams
- Housing: Individually in polycarbonate metabolism cages with wire bottoms
- Diet (e.g. ad libitum): Harlan Teklad Rat/Mouse 2018 Diet (Harlan Teklad, Madison, WI) ad libitum
- Water (e.g. ad libitum): Tap water (St. Paul, MN municipal water supply) ad libitum
- Acclimation period: 5 days prior to study initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6-23.9
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 May, 2014 To: 16 May 2014
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test article was dosed as received.
- Duration and frequency of treatment / exposure:
- Animals received a single dose via oral gavage.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 907 mg/kg bw/day (actual dose received)
- Remarks:
- Treatment group
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Control group
- No. of animals per sex per dose / concentration:
- 3 males were utilized in the control group (0 mg/kg body weight) and 6 males were utilized in the treatment group (907 mg/kg body weight).
- Control animals:
- yes, concurrent no treatment
- Positive control reference chemical:
- None
- Details on study design:
- - Dose selection rationale: The dose was not expected to cause toxicity based on previous acute oral toxicity testing.
- Rationale for animal assignment (if not random): Random - Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, excretion)
- Tissues and body fluids sampled: urine, faeces, serum, liver, subcutaneous fat
- Time and frequency of sampling: Serum (1, 6, 24, 48, 72, and 96 hours post-dose) and urine and feces (0-6, 6-24-24-48, 48-72, and 72-96 hours post-dose) samples were collected. Liver and subcutaneous fat samples were collected from control and treated animals at termination on Study Day 5. Serum, urine, feces, and liver samples were analyzed for the parent compound. Fat samples and potential metbolites were not analyzed since virtually all of the adminstered dose was recovered from the feces of the treated animals and all serum and urine samples had test article concentrations below the lower limit of quantitation.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Test article concentrations in the serum, urine and liver samples of treated animals were below the limit of quantitation. As a result, the test article does not appear to be absorbed following oral exposure.
- Type:
- excretion
- Results:
- Virtually all of the adminstered dose was recovered in the feces of the treated animals between 6 and 48 hours after dosing.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Test article concentrations in the serum, urine and liver samples of treated animals were below the limit of quantitation. As a result, the test article does not appear to be absorbed following oral exposure.
- Details on distribution in tissues:
- Test article concentrations in the serum, urine and liver samples of treated animals were below the limit of quantitation.
Transfer into organs
- Transfer type:
- other: Distribution to liver
- Observation:
- no transfer detectable
- Remarks:
- Test article concentrations in the serum and liver samples of the treated animals were below the limit of quantitation.
- Details on excretion:
- Virtually all of the administered dose was recovered in the feces of the treated animals between 6 and 48 hours after dosing.
Toxicokinetic parameters
- Toxicokinetic parameters:
- other:
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- Metabolites were not analyzed as virtually the entire administered dose was recovered in the feces of the treated animals, indicating that the test article was likely not absorbed.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, the test article was not absorbed following oral administration in rats. Based on these findings, it is considered unlikely that bioaccumulation of the test article would occur in humans following oral exposure.
- Executive summary:
The absorption and excretion of the test article was investigated in male Sprague Dawley rats. The study was not conducted under GLP conditions. The test method was based on a custom protocol. Animals were administered a single dose of 907 mg/kg (treated, n=6) or 0 mg/kg (control, n=3) via oral gavage. Serum (1, 6, 24, 48, 72, and 96 hours post-dose) and urine and feces (0-6, 6-24-24-48, 48-72, and 72-96 hours post-dose) samples were collected. Liver and subcutaneous fat samples were collected from control and treated animals at termination on Study Day 5. Serum, excreta and liver samples were analyzed for the test article. No treatment-related deaths occurred and no abnormal clinical signs were observed during the study. Treated animals gained weight over the course of the study. Test article concentrations were below the lower limits of quantitation in all serum, urine and liver samples analyzed. Virtually all of the administered dose was recovered in the feces of the treated animals between 6 and 48 hours after dosing (101.42% recovered from 0-96 hours) Recoveries were based on the lower limit of quantitation and slightly overstate actual recoveries. Based on the results of the study, the test article was not absorbed following oral administration in rats. Based on these findings, it is considered unlikely that bioaccumulation of the test article would occur in humans following oral exposure.
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