Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 261-818-3 | CAS number: 59587-38-1
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Objective of study:
- other: Biopersistence Screening
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The potential for the test substance, when administered by gavage, to be absorbed and to accumulate in a mammalian system was examined.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-octane-1-sulfonic acid
- Cas Number:
- 913252-35-4
- IUPAC Name:
- 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-octane-1-sulfonic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Purity: 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Details on species / strain selection:
- The Crl:CD(SD) rat was selected based on consistently acceptable health status and on extensive experience with this strain at the test facility.
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- Daily for 10 days
Doses / concentrations
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- 10 male animals
- Control animals:
- yes
- other: Deionized water
- Positive control reference chemical:
- Potassium perfluoroalkyl sulfonate (10 mg/kg/day) and Octanoic acid, pentadecafluoro-, ammonium salt (20 mg/kg/day)
- Statistics:
- Descriptive statistics (e.g. mean, standard deviation) were used.
Results and discussion
- Preliminary studies:
- In the rangefinding study, 5 male rats were dosed with test substance by oral gavage at a dosage of 1000 mg/kg. The study was terminated after 3 days of dosing because the animals experienced body weight losses of up to 13%. The study conducted at 200 mg/kg/day was also terminated after 6 days of dosing because of body weight losses of up to 19% in the rats. The dosage of 25 mg/kg/day was selected for the main study and was expected to produce minimal body weight loss or toxicity.
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- The Cmax for test substance was 95 μM equivalents.
- Type:
- absorption
- Results:
- The AUCINF/D for test substance was 17,865
- Type:
- other:
- Results:
- The total fluorine concentration in the livers from rats dosed with test substance was 423.64 μM equivalents at day 10 and 8.95 μM equivalents at day 94
- Type:
- other:
- Results:
- The total fluorine concentration in the fat from rats dosed with test substance was 8.07 μM equivalents at day 10.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The test substance normalized μM equivalents in rat increased during the dosing period and did not appear to reach steady-state. The Cmax for test substance was 95 μM equivalents. The total internal exposure resulting from a normalized dose was described by AUCINF/D and was the basis for comparison between test substance and the positive controls. The AUCINF/D for test substance was 17865 as compared to AUCINF/D values of 522474 and 81507 for the postive controls, respectively
Toxicokinetic parametersopen allclose all
- Key result
- Toxicokinetic parameters:
- Cmax: 95 μM equivalents
- Key result
- Toxicokinetic parameters:
- AUC: 17865
- Remarks:
- Dose-adjusted areas under the curve
Any other information on results incl. tables
The mean relative liver weight (liver/body weight) of rats dosed with the test substance was 12% higher than the negative control weight at day 10 and 6% higher at day 94. The mean relative liver weight of rats dosed with one of the positive controls was 23% higher at day 10 than the liver weight of rats dosed with the test substance. By day 94, the weights were the same. Therefore, the relative liver weights of rats dosed with the test substance were somewhat affected.
Applicant's summary and conclusion
- Conclusions:
- Absorption of test substance by rats following oral gavage administration was evident based on quantification of fluorine in the blood, liver, and fat. A very minimal increase in relative liver weight was observed for test substance. Fluorine concentrations and the AUCINF/D were significantly lower than those in rats dosed with the positive control materials.
- Executive summary:
The study was conducted to evaluate the potential for test substance, when administered by gavage, to be absorbed and to accumulate in a mammalian system. Specific experimental endpoints included clinical signs, body weights, liver weights, and total fluorine concentrations in blood, fat and liver. Two groups of 5 male Crl:CD(SD) rats each were exposed to 25 mg/kg/day of test substance for 10 consecutive days. Blood was collected from the orbital sinus of 5 rats approximately 2 hours after dosing on test days 1 and 5. Approximately 2 hours after the last dose, these rats were euthanized and blood, livers and fat were collected. Blood was collected from the orbital sinus of the remaining 5 rats on test days 13, 24, and 52. These rats were euthanized on test day 94 and blood, livers and fat were collected. Body weights and clinical signs were recorded on each day of dosing and then weekly during the recovery period. A negative control, deionized water, and 2 positive controls were tested as described for test substance.
No test substance-related clinical signs or body weight effects were observed. Liver weights were somewhat affected in rats dosed with the test substance. The increased relative liver weights appeared to be associated with increased concentrations of fluorine containing test or positive control substances, particularly at Day 10. Steady-state for fluorine in the blood was not achieved during the 10-day dosing period with the test substance. Dose adjusted areas under the curve (AUCINF/D) for positive controls were approximately 29-fold and 5-fold higher than the AUCINF/D for the test substance. Under the conditions of this study absorption of test substance by rats following oral gavage administration was evident based on quantification of fluorine in the blood, liver, and fat. A very minimal increase in relative liver weight was observed for the test substance. Changes in relative liver weights were greater for the positive controls, and were associated with greater concentrations of fluorine in the liver particularly at Day 10. The tissue concentrations declined after cessation of dosing with some retention of fluorine in the blood and liver based on quantification on the end of the study. However, fluorine concentrations and the AUCINF/D were significantly lower than those in rats dosed with the positive control materials.
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.