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EC number: 249-616-3 | CAS number: 29420-49-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
- EC Number:
- 249-616-3
- EC Name:
- Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
- Cas Number:
- 29420-49-3
- Molecular formula:
- C4HF9O3S.K
- IUPAC Name:
- potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot 2
- Expiration date of the lot/batch: No data
- Purity test date: 17 April, 2000
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature, protected from light.
- Stability under test conditions: Dosing solutions were considered stable withing 14 days of preparation. All formulated test materials were stored refrigerated in amber glass bottles.
- Solubility and stability of the test substance in the solvent/vehicle: The test article was dissolved in carboxymethylcellulose. Samples were retained predose and on the last day of dosing for each batch and were analysed for proper formulation.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was dissolved in carboxymethylcellulose.
- Final preparation of a solid: The test article was dissolved in carboxymethylcellulose to allow dosing via oral gavage at a dose volume of 25 mL/kg.
FORM AS APPLIED IN THE TEST: The test article was dissolved in carboxymethylcellulose.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories,Inc.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Approximately 8 weeks old.
- Weight at study initiation: Males: 209 to 253 grams, Females: 178 to 212 grams
- Fasting period before study: No data
- Housing: Individually in screen-bottom stainless steel cages.
- Diet (e.g. ad libitum): Teklad Certified Rodent Diet (#8728) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 28-26
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 31 August, 2000 To: 13 October, 2000
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The doses were administered at 25 mL/kg body weight.
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test article was dissolved in 1% carboxymethylcellulose in water.
VEHICLE
- Concentration in vehicle: Dosing solutionswere formulated to allow for dosing of 0 (vehicle control), 100, 300, and 900 mg/kg at a dose volume of 25 mL/kg body weight.
- Amount of vehicle (if gavage): 25 mL/kg body weight
- Lot no.: 69H0028 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Dose concentrations were verified using HPLC/MS
- Duration of treatment / exposure:
- Daily for 28 days.
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw (total dose)
- Remarks:
- Vehicle control (1% CMC in water).
- Dose / conc.:
- 100 mg/kg bw (total dose)
- Dose / conc.:
- 300 mg/kg bw (total dose)
- Dose / conc.:
- 900 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 10 (5 additional/sex in the control and high dose groups as recovery animals).
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on a 10-day range-finding study.
- Rationale for animal assignment: Random
- Rationale for selecting satellite groups: Random
- Post-exposure recovery period in satellite groups: 14 days - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Observations for mortalityand moribundity were recorded twice daily (a.m. and p.m.). Cageside observations were recorded at approximately one to two hours postdose daily and when a change was noted.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Detailed clinical observations were recorded once before the first dose and at least weekly there after or when a change was noted.
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded pretest,on Study Day 1, approximately weekly, prior to terminal fasting, and prior to necropsy (fasted weight). The pretest body weights are not included in this report but are located in the raw data. The fasted body weights recorded prior to necropsy were used only for the calculation of relative organ weights.
FOOD EFFICIENCY:
- Feed consumption was measured approximately weekly.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood samples for hematological analysis were obtained via cardiac puncture prior to necropsy. The animals were anesthetized with carbon dioxide for the collection. Feed was withheld overnight prior to collection.
- Anaesthetic used for blood collection: No, blood collected prior to necropsy.
- Animals fasted: Yes
- How many animals: All
- Parameters checked: The blood samples were evaluated for the following parameters: total and relative differential leukocyte counts, erythrocyte counts, hemoglobin concentration, hematocrit value, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet counts, prothrombin time, and activated partial thromboplastin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Blood samples for hematological analysis were obtained via cardiac puncture prior to necropsy. The animals were anesthetized with carbon dioxide for the collection. Feed was withheld overnight prior to collection.
- Anaesthetic used for blood collection: No, blood collected prior to necropsy.
- Animals fasted: Yes
- How many animals: All
- Parameters checked: The samples were processed and evaluated for the following parameters: total protein, albumin, globulin, albumin/globulin ratio, glucose, cholesterol, triglycerides, total bilirubin, urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyltransferase, calcium, phosphorus, sodium, potassium, and chloride.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: DuringWeek 4, each animal was assessed for sensory reactivity to stimuli of different types (e.g., auditory and visual), grip strength, and motor activity
- Dose groups that were examined: All
- Battery of functions tested: sensory activity, grip strength, motor activity
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weights were recorded for the following organs prior to fixation: adrenal glands, brain, heart, kidneys, liver, ovaries, spleen, thymus, and testes. Paired organs were weighed together. The following organs and tissues were examined in situ, dissected free, and fixed in 10% neutral buffered formalin: adrenal glands, aorta, bone marrow (sternum), brain (brain stem, cerebellum, cerebrum), cervix, epididymides, esophagus, eyes (with optic nerve), femur (with articular surface), gross lesions, Harderian gland, heart, large intestine (cecum, colon, rectum), small intestine (duodenum, ileum, jejunum), kidneys, lacrimal gland, liver, lungs (with bronchi), lymph nodes (mesenteric, mandibular), mammary gland, ovaries, oviducts, pancreas, pituitary gland, prostate gland, salivary gland (mandibular), sciatic nerve, seminal vesicles, skeletal muscle, spinal cord (cervical, thoracic, lumbar), spleen, stomach (forestomach, glandular), testes, thymus, thyroid/parathyroid, tongue, trachea, uterus, urinary bladder, vagina, and Zymbal's gland.
HISTOPATHOLOGY: Yes
Histopathology was performed on all tissues from teh vehicle control, high-dose and recovery animals and on all gross lesions.
The following tissues were examined: adrenal glands, aorta, bone marrow (sternum), brain (brain stem, cerebellum, cerebrum), cervix, epididymides, esophagus, eyes (with optic nerve), femur (with articular surface), gross lesions, Harderian gland, heart, large intestine (cecum, colon, rectum), small intestine (duodenum, ileum, jejunum), kidneys, lacrimal gland, liver, lungs (with bronchi), lymph nodes (mesenteric, mandibular), mammary gland, ovaries, oviducts, pancreas, pituitary gland, prostate gland, salivary gland (mandibular), sciatic nerve, seminal vesicles, skeletal muscle, spinal cord (cervical, thoracic, lumbar), spleen, stomach (forestomach, glandular), testes, thymus, thyroid/parathyroid, tongue, trachea, uterus, urinary bladder, vagina, and Zymbal's gland. - Statistics:
- Means and standard deviations were calculated for all quantitative data. Treated groups of the same sex were compared to Group 1 (vehicle control) at common time points using an ANOVA with a post hoc Dunnett's t Test (Dunnett, C.W., J. Amer. Statis. Assoc., 50:1096-1121, 1955) or another appropriate test. A two-sided c_of 0.05 or 0.01 was used to determine if statistically significant differences existed between the vehicle control and the treated groups.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Clinical observations consisted of localized alopecia (back, limbs, neck, and underside), urine stained abdominal fur, scabbed area on back and neck, and soft or liquid feces. These findings are considered incidental and unrelated to testmaterial administration.Additional cage side observations were all normal.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment-related effects on body weights for either Main Study or Recovery animals. On StudyDay 36, the mean bodyweight in males that received 900 mg/kg/day test article was decreased by 7% when compared to the corresponding controls. This finding was considered incidental. Throughout the study, bodyweight changes intreatment groups were calculated and compared to the corresponding control groups with no significant findings recorded for either Main Study or Recovery animals
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Throughout the study, absolute feed consumption per treatment group was calculated and compared to the corresponding control groups with no significant findings recorded for either Main Study or Recovery animals.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The reported significant hematological findings are considered incidental and not associated with test material administration.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Main Study findings in males that received _>300mg/kg/day T-7485 indicate significant decreases in serum phosphorus (approximately 16% of the control values) and potassium (approximately 20% of the control values). In contrast, an increase in chloride levels in males that received 900 mg/kg/day test article (4% above the control values) was recorded. In the absence of similar findings in Recovery animals, the changes in phosphorus, potassium, and chloride levels appear to be associated with test material administration but do not appear to be toxicologically or biologically significant, as indicated by historical data. Other incidental findings do not appear to be related to administration of the test material.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Assessment of neurological effects on animals treated with the test article included peripheral neuropathy, motoractivity, and audio/visual evaluations. There were no test material-related effects on motoractivity or audio/visual.
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Absolute and relative male liver (between 25% to 30%) and female kidney (9% to 11%) weights were significantly increased in animals that received 900 mg/kg/day test article when compared to the corresponding controls. These significant changes were not recorded during the recovery period, and since there does not appear to, be an effect of body weight on organ development, these data suggest the changes are test material-related. However, the biological and toxicological significance is unclear due to the lack of any supportive gross or histopathological findings. The remaining significant findings are considered incidental and unrelated to test material administration.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Only one gross lesion was recorded at necropsy and was not considered to be test material-related.
- Neuropathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Assessment of neurological effects on animals treated with the test article included peripheral neuropathy, motoractivity, and audio/visual evaluations. There were no test material-related effects on motoractivity or audio/visual.
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The microscopic lesions observed in the test animals are considered to be incidental and in no way related to receiving the test material.
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 900 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) is 900 mg/kg/day.
- Executive summary:
The subacute oral toxicity of the test article was evaluated in Sprague Dawley rats following 28 consecutive daily doses. This study was performed in compliance with OECD GLP (1981). The study design was based on OECD 407. The test material was prepared in 1% carboxymethyl-cellulose in deionized water (vehicle). Rats (10/sex/dose) received 0 (vehicle), 100, 300, or 900 mg/kg/day of the test article via oral gavage at a dose volume of 25 mL/kg for 28 consecutive days. In addition, recovery groups (5/sex/dose) received 0 or 900 mg/kg/day of the test article in a similar manner. With the exception of the recovery groups, all groups were euthanized 24 hours following the last dose. The recovery groups were euthanized following a 14-day recovery period. Parameters evaluated: clinical observations (pretest and at least weekly thereafter or when a change was noted), body weights (weekly), food consumption (weekly), neurological function observations (Week 4), gross necropsy (termination), hematology (termination), clinical chemistry (termination), organ weights of select organs (termination), and histopathology of select organs and tissues (termination). All animals survived. Localized alopecia and scabbed area on back and neck were observed among all dose groups. At 900 mg/kg, one male exhibited urine-stained abdominal fur, and another male exhibited soft or liquid feces. These clinical observations were considered incidental and unrelated to test material administration. There were no test article-related effects on body weights or food consumption. Absolute and relative male liver (25% to 30%) and female kidney (9% to 11%) weights were significantly increased in animals that received 900 mg/kg/day test article when compared to the corresponding controls. These significant changes were not recorded during the recovery period, and since there does not appear to, be an effect of body weight on organ development, these data suggest the changes are test material-related. However, the biological and toxicological significance is unclear due to the lack of any supportive gross or histopathological findings. The remaining significant findings are considered incidental and unrelated to test material administration. No toxicologically relevant changes were noted in the clinical chemistry and hematology parameters evaluated or tissues subjected to histopathological evaluation. Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) is 900 mg/kg/day.
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