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Diss Factsheets
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EC number: 700-403-8 | 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
- Objective of study:
- other: pharmacokinetic
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was administered orally by gavage to male mice for 7 days at dose levels of 0, 30, 300 and 1000 mg/kg/day. Study parameters included clinical signs, body weight, necropsy, organ weight, histopathology, and pharmacokinetic evaluation.
- GLP compliance:
- no
Test material
- Details on test material:
- - Purity: not reported as such
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- mouse
- Strain:
- other: Crl:CD1(ICR)
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- Daily for 7 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- 5 males/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- The concentration of P1OH2 in liver was approximately forty times higher than the plasma concentration but the elimination rate from plasma and liver appear to be similar. This implies that the higher concentration in liver is the result of transient partitioning during distribution. The concentrations of PFHxA, 5-3A, and 6-2A were approximately equal in the liver and plasma. P1OH2 was the only compound with concentrations above the limit of quantitation in multiple time points in the fat. Area counts of the glucuronide metabolite of 6-2FTOH in plasma show that it was eliminated at a rate consistent with P1OH2. Other analytes monitored but below the limit of quantitation were P1OH1, PFPeA, PFBuA, PFHpA, 6-2FTOH, PEGOH_A, PEGOH_B, PEGOH_C, PEGOH_D, and 4-3A.
6-2UA was below the limit of quantitation in liver. P1OH2, PFHxA, 5-3 A, 6-2A, and 6-2UA were below the limit of quanititation in fat. Steady state was achieved by day 4 for P1OH2, PFHxA, 5-3A, and 6-2A in both plasma and liver.
Applicant's summary and conclusion
- Executive summary:
The test substance was administered orally by gavage to male mice for 7 days at dose levels of 0, 30, 300 and 1000 mg/kg/day. Study parameters included clinical signs, body weight, necropsy, organ weight, histopathology, and pharmacokinetic evaluation. The concentration of P1OH2 in liver was approximately forty times higher than the plasma concentration but the elimination rate from plasma and liver appear to be similar. This implies that the higher concentration in liver is the result of transient partitioning during distribution. The concentrations of PFHxA, 5-3A, and 6-2A were approximately equal in the liver and plasma. P1OH2 was the only compound with concentrations above the limit of quantitation in multiple time points in the fat. Area counts of the glucuronide metabolite of 6-2FTOH in plasma show that it was eliminated at a rate consistent with P1OH2. Other analytes monitored but below the limit of quantitation were P1OH1, PFPeA, PFBuA, PFHpA, 6-2FTOH, PEGOH_A, PEGOH_B, PEGOH_C, PEGOH_D, and 4-3A. 6-2UA was below the limit of quantitation in liver. P1OH2, PFHxA, 5-3 A, 6-2A, and 6-2UA were below the limit of quanititation in fat. Steady state was achieved by day 4 for P1OH2, PFHxA, 5-3A, and 6-2A in both plasma and liver. No test substance-related effects on mortality, body weight effects or adverse clinical signs were observed at any dose level. At 1000 mg/kg substance-related and adverse effects were observed in the livers of male mice consisting of minimal to mild hepatocellular degeneration/necrosis. At 30 mg/kg/day and 300 mg/kg/day, non-adverse liver effects (hypertrophy) were present. Test substance-related but non adverse microscopic findings were observed in the teeth and femur of mice administered ≥ 30 mg/kg/day. These changes included incomplete decalcification of enamel (incisor teeth) and bone trabeculae (femur). These findings were likely consistent with exposure to a fluorine-containing test substance and were not associated with any histopathological changes suggestive of tissue injury or any adverse functional consequences in these tissues and were not considered to be adverse. The no observable adverse effect level (NOAEL) was estimated to be 300 mg/kg/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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