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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- other: National Toxicology Program (NTP) Database
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- mammalian germ cell cytogenetic assay
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: Not specified
- Expiration date of the lot/batch:
- Purity test date:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS:
Test animals
- Species:
- rat
- Strain:
- other: Harlan Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Labs
- Age at study initiation: No data
- Weight at study initiation: No data
- Assigned to test groups randomly: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Deionized water with 2% Tween 80
- Justification for choice of solvent/vehicle: No data
- Concentration of test material in vehicle: Dose formulations were prepared to deliver 0 (vehicle control), 31.3, 62.5, 125, or 250 mg/kg test article.
- Amount of vehicle (if gavage or dermal): No data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dose formulations were prepared to deliver 0 (vehicle control), 31.3, 62.5, 125, or 250 mg/kg test article.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
- Post exposure period:
- Blood samples were collected 24 hours after the last dose was adminstered.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Vehicle Control (Deionized water with 2% Tween 80)
- Dose / conc.:
- 31.3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 62.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 125 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- None
Examinations
- Tissues and cell types examined:
- Blood samples were examined via flow cytometry to measure the number of micronucleated polychromatic and normochromatic erythrocytes.
- Evaluation criteria:
- The micronucleus data were tabulated as the mean frequency of the micronucleated erythrocytes per 1000 cells per animal, plus or minus the standard error of the mean amoung animals within a treatment group. The frequency of micronucleated cells among Polychromatic erythrocytes (PCE) and Normochromatic erythrocytes (NCE). Pairwise comparisons were analyzed between each exposure group and control group using an unadjusted one-tailed Pearson X^2 test. A test was considered positive if the trend test P value was 0.025 or less or the P value for any single exposure group was 0.025/N or less where N is the number of treatment groups. Trend test P values between 0.025 and 0.05 were considered to be equivocal if accompanied by a monotonic increase in the frequency of micronuclei over the dose range investigated. All other responses were considered to be negative.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- other:
- Remarks:
- Treatment with the test article up to 250 mg/kg/day for 28 days did not induce a statistically significant increase in the frequency of micronucleated erythrocytes per 1000 cells per animal in polychromatic or normochramtic erythrocytes.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, the test article is negative in the mammalian micronucleus test in male and female rats.
- Executive summary:
The genotoxic potential of the test article was evaluated in Harlan Sprague-Dawley rats. Rats (5/sex/group) were administered 0 (vehicle control: Deionized water with 2% Tween 80), 31.3, 62.5, 125, or 250 mg/kg test article via oral gavage for 28 days. Peripheral blood samples were collected from each animal 24 hours after administration of the final dose. Blood samples were examined via flow cytometry to measure the number of micronucleated polychromatic and normochromatic erythrocytes. The micronucleus data were tabulated as the mean frequency of the micronucleated erythrocytes per 1000 cells per animal, plus or minus the standard error of the mean amoung animals within a treatment group. The frequency of micronucleated cells among Polychromatic erythrocytes (PCE) and Normochromatic erythrocytes (NCE). Pairwise comparisons were analyzed between each exposure group and control group using an unadjusted one-tailed Pearson X^2 test. A test was considered positive if the trend test P value was 0.025 or less or the P value for any single exposure group was 0.025/N or less where N is the number of treatment groups. Trend test P values between 0.025 and 0.05 were considered to be equivocal if accompanied by a monotonic increase in the frequency of micronuclei over the dose range investigated. All other responses were considered to be negative. Treatment with the test article up to 250 mg/kg/day for 28 days did not induce a statistically significant increase in the frequency of micronucleated erythrocytes per 1000 cells per animal in polychromatic or normochramtic erythrocytes. Based on the results of the study, the test article is negative in the mammalian micronucleus test in male and female rats.
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.