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EC number: 266-733-5 | CAS number: 67584-55-8
- 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:
- 29 April 2002 to 10 May 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was performed using a defined internal protocol, but not performed under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Objective of study:
- other: Toxicokinetics . To compare the serum and liver half-life of elimination for three N-methyl perfluorobutyl sulfonamido compounds with perfluorobutanesulfonate
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol number ST-75
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was not performed under GLP conditions, but met the internal Strategic Toxicology Laboratory GLP program procedure
Test material
- Reference substance name:
- C4-acrylate
- IUPAC Name:
- C4-acrylate
- Details on test material:
- - Name of test material (as cited in study report:N-Methyl perfluorobutylsulfonamido ethyl acrylate (N-MeFBSE acrylate or C4 acrylate), T-7600.6
- Physical state: Solid
- Lot/batch no.: Lot 1
- Storage condition of test material: Stored tightly sealed at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: 6-8 weeks in age
- Weight at study initiation: approx. 150-250 grams
IN-LIFE DATES: From: 29 April 2002 To: 10 May 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): Propylene glycol - Duration and frequency of treatment / exposure:
- Treatment time was temporary during the single dose oral gavage time.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30 mg/kg dose of the test compound in propylene glycol at a volume of 5 mL/kg.
- No. of animals per sex per dose / concentration:
- N=3/dose group/exposure period.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 4 days (100 hours)
- Frequency of observations and weighing: at 4 hours, 28 hours and 100 hours
- Necropsy of survivors performed: Yes
- Other examinations performed:body and liver weights, gross necropsy - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify); serum and liver. Urine was stored and collected for future analysis.
- Time and frequency of sampling: at 4 hours, 28 hours and 100 hours
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled (delete / add / specify):serum and liver
- Time and frequency of sampling: at 4 hours, 28 hours and 100 hours
- From how many animals: (samples pooled or not): 42 total, seven of which were treated with the test article, 6 controls , the remainder were animals tested with other similar compounds.
- Method type(s) for identification (e.g. GC-FID, GC-MS, HPLC-DAD, HPLC-MS-MS, HPLC-UV, Liquid scintillation counting, NMR, TLC): GC, GC/MS, LC/MS, 1H-NMR and 19F-NMR techniques. 15 samples of liver from the entire study were submitted for total fluorine analysis using 9000F Flouride Analysis System.
- Limits of detection and quantification: The LOD of the total fluorine analytical method used was 0.5 ppm and each samplewas analyzed in triplicate.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- 3.1% and 4.3% absorption in serum and in the liver, respectively, 28 hours post dose
Toxicokinetic parameters
- Toxicokinetic parameters:
- half-life 1st: Apparent serum half-life was approximately 21 hours
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- fluorine concentrations were measured
Any other information on results incl. tables
There were no significant effects of treatment on body weights or liver weights. All animals gained weight over the course of the study period. Gross necropsy observations showed that all organ tissues appeared to be normal when compared to the controls, except that mottled kidneys were found for some animals that recieved treatments. The kidney mottling was most likely due to blood pooling in the kidneys at necropsy and was not considered to be compound-related. Animals that received the test article at 30 mg/kg had average total fluorine concentrations in serum of 6.0 ppm on day zero (4 hours post dose), 12.1 ppm on day one (28 hours post dose) and 1.1 ppm on day four (100 hours after dose). The half life elimination times for the test compound in the serum was 21 hours.
The average liver total fluorine concentrations were 9.6, 12.7 and 2.6 ppm after 4 hours, 28 hours or 100 hours post dose, respectively. The apparent total fluorine elimination rates were similar in both serum and liver for animals treated with the test compound.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: The limitations of the study do not allow conclusions to be made regarding the time post-dose at which the maximum tissue TOF (total organic fluorine) concentrations were achieved, or possible multiphasic elimination patterns.
The test compound elimination half life is significantly less than 4 days in both the serum and liver of rats (of approximatley 21 hours).
The test compound would not be expected to significantly accumulate in the liver or serum following repeated exposure. - Executive summary:
Male Sprague-Dawley rats received a single 30 mg/kg dose of the test compound in propylene glycol by oral gavage at a volume of 5 mL/kg body weight. The vehicle control group rats received a single dose of ethylene glycol at a volume of 5 mL/kg. Necropsies were performed at 4 hours, 28 hours and 100 hours post dose. At necropsy there were no significant differences in body weight or gross macroscopic observations between any of the treatment groups and the control group. The apparent elimination half-life of three compounds were compared to the half-life of PFBS in liver and serum.
The percentage for the test compound dose absorbed and present in the serum and liver were estimated as 3.1 % and 4.3%, in the serum and in the liver, respectively, 28 hours post dose.
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