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EC number: 812-244-2 | CAS number: 957209-18-6
- 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
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Objective of study:
- absorption
- excretion
- metabolism
- Principles of method if other than guideline:
- - Principle of test: The pharmacokinetic properties of the test article were evaluated in Sprague Dawley rats.
- Short description of test conditions: Non-fasted rats (5/sex) received a single oral 300 mg/kg body weight dose of the test article via gavage. Control rats (5/sex) received a single oral 5 mL/kg body weight dose of olive oil in place of the test article in the same manner. T
- Parameters analysed / observed: he animals were observed for mortality and morbidity immediately following dosing and throughout the duration of the study. Body weights were collected prior to treatment and on Days 1-4, 6, 8, 10, 13, and 14. Urine and feces were collected from all animals on days 1-4, 9, 11, and 14. Urine volumes were approximated and recorded and feces samples were weighed and recorded. Urine samples were analyzed with NMR. At termination, blood was collected from each animal for serum analysis. At termination gross necropsy was performed on all animals, and the livers were excised and weighed. All samples were stored at -70 C for future analysis. - 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: 3M Company, NB#159571-76, Purity: 99.9%
- Expiration date of the lot/batch: Not specified
- Purity test date: 17 February, 2012
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was unchanged. - Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 124-186 g
- Housing: All animals were group housed in solid bottom cages prior to the study and on days when urine and feces collections were not scheduled. During the scheduled periods of urine and feces collections, all animals were individually housed in wire bottom metabolism caging.
- Diet (e.g. ad libitum): Harlan Teklad Rat/Mouse 2018 Diet (Harlan Teklad, Madison, WI), ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: At least 5 days.
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 March, 2012 To: 26 March, 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test article was mixed with olive oil and administered as a suspension.
- Duration and frequency of treatment / exposure:
- Animals received a single oral dose via gavage.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw (total dose)
- Dose / conc.:
- 300 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- None
- Details on study design:
- - Dose selection rationale:
- Rationale for animal assignment: Random. - Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, feces, serum, liver
- Time and frequency of sampling: Urine and feces were collected from all animals on days 1-4, 9, 11, and 14. Serum was collected prior to necropsy and livers collected at necropsy.
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine
- Time and frequency of sampling: Urine was collected from all animals on days 1-4, 9, 11 and 14.
- From how many animals: All animals
- Method type(s) for identification: 19F-NMR
- Limits of detection and quantification: Not specified.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- excretion
- Results:
- Based on urine NMR analysis, less than 1% of the test article dose was recovered as perfluorosuccinate dianion and inorganic fluoride.
- Type:
- metabolism
- Results:
- Based on urine NMR analysis, less than 1% of the test article dose was recovered as perfluorosuccinate dianion and inorganic fluoride.
- Type:
- absorption
- Results:
- Based on urine NMR analysis, less than 1% of the test article dose was recovered as perfluorosuccinate dianion and inorganic fluoride.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Based on urine NMR analysis, less than 1% of the test article dose was recovered as perfluorosuccinate dianion and inorganic fluoride. Based on the data obtained from this study, the primary route of elimination for the test article could not be determined. The test article appeared to be eliminated more readily in males vs. females with an average urinary half life of 2.5 days and 3.32 days, respectively.
- Details on excretion:
- Based on urine NMR analysis, less than 1% of the test article dose was recovered as perfluorosuccinate dianion and inorganic fluoride. Based on the data obtained from this study, the primary route of elimination for the test article could not be determined. The test article appeared to be eliminated more readily in males vs. females with an average urinary half life of 2.5 days and 3.32 days, respectively.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Based on urine NMR analysis, less than 1% of the test article dose was recovered as perfluorosuccinate dianion and inorganic fluoride.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, the average urinary half-life of the test article was 2.5 days in males and 3.32 days in females. The primary route of elimination for the test article could not be determined from the data.
- Executive summary:
The pharmacokinetic properties the test article were evaluated in Sprague Dawley rats. Non-fasted rats (5/sex) received a single oral 300 mg/kg body weight dose of the test article suspended in olive oil via gavage. Control rats (5/sex) received a single oral 5 mL/kg body weight dose of olive oil in place of the test article in the same manner. The animals were observed for mortality and morbidity immediately following dosing and throughout the duration of the study. Body weights were collected prior to treatment and on Days 1-4, 6, 8, 10, 13, and 14. Urine and feces were collected from all animals on days 1-4, 9, 11, and 14. Urine volumes were approximated and recorded and feces samples were weighed and recorded. Urine samples were analyzed with NMR. At termination, blood was collected from each animal for serum analysis. At termination gross necropsy was performed on all animals, and the livers were excised and weighed. All samples were stored at -70 C for future analysis. All animals survived until termination. Overall, compared to sex-matched controls, there were no statistically significant differences in terminal body weight, body weight gain, or liver weight to body ratios. Some soft stool was noted in one test female on Day 3. Dark colored urine was noted in 3 male control animals at Day 4, however, the discoloration appeared to be due to food crumbs in the collection cup. There were no gross lesions in any test animal at necropsy. F-NMR urine analysis revealed the presence of trace levels (1%) of perfluorosuccinate dianion and inorganic fluoride anion in all urine samples from all test animals from Day 1 to Day 14. The urinary half-life in males and females was 2.5 days and 3.32 days respectively. Based on the results of the study, the average urinary half-life of the test article was 2.5 days in males and 3.32 days in females. The primary route of elimination for the test article could not be determined from the data.
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