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EC number: 811-522-0 | CAS number: 62880-93-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 May, 2015 - 25 May, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- sodium 2-methyl-2-{3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propanamido}propane-1-sulfonate
- EC Number:
- 811-522-0
- Cas Number:
- 62880-93-7
- Molecular formula:
- C15H17F13NNaO4S2
- IUPAC Name:
- sodium 2-methyl-2-{3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propanamido}propane-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): NS-3000
- Appearance: Off-white powder
- Storage condition of test material: At room temperature desiccated
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Age at study initiation: Young adult animals (approx. 9 weeks old)
- Weight at study initiation: 181 to 203 g, ± 20% of the sex mean.
- Fasting period before study: Overnight prior to dosing and food was returned approximately 4 hours after dosing.
- Housing: All animals were housed individually in clean, stainless steel, wire-mesh cages suspended above cage-board.
- Diet: Free access to basal diet (PMI Nutrition International, LLC, Certified Rodent LabDiet® 5002)
- Water: Free access to municipal water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3 - 21.4
- Humidity (%): 32.1 - 59.1
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized water
- Details on oral exposure:
- GAVAGE METHOD: plastic feeding tubes.
Frequency: single dosage, on Day 1.
VEHICLE:
The vehicle used in preparation of the test substance formulation was deionized water (prepared on-site). The 1N hydrochloric acid used to adjust the pH of the test substance formulation was prepared using hydrochloric acid.
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight.
DOSAGE PREPARATION: On each day of dosing, a sufficient amount of test substance was weighed into a glass container. Approximately 95% of the vehicle was added. The contents were mixed using a probe sonicator at 30% amplitude in 1 minute cycles to achieve a uniform formulation.
The remaining vehicle and a stir bar were added. The pH of the dosing formulation was adjusted to 6.59 to 7.61 using 1N hydrochloric acid. The contents were stirred continuously throughout use. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 (2 groups of three females in a stepwise manner)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: Approximately 15 minutes (± 5 minutes) and 1, 2 and 4 hours post-dosing on study day 0 and twice daily, once in the morning and once in the afternoon, thereafter for 14 days.
Clinical observations: Approximately 15 minutes (± 5 minutes) and 1, 2, and 4 hours post-dosing on study day 0 and once daily thereafter for 14 days.
Body weights: Body weights were obtained and recorded on study days 0 (initiation), 7, and 14 (termination).
- Necropsy of survivors performed: On study day 14, the rats were euthanized by carbon dioxide inhalation. The major organ systems of the cranial, thoracic, and abdominal cavities and the eyes and skin were examined for all animals.
- Other examinations performed: none. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived to the scheduled necropsy (study day 14).
- Clinical signs:
- other: There were no clear test substance-related clinical observations. The only clinical observation was soft feces for 1 female on study day 0 (15 minutes and 4 hours post-dosing).
- Gross pathology:
- There were no test substance-related macroscopic findings at the scheduled necropsy. The only gross lesion observed was an enlarged pituitary gland for one female.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity study with rats, performed according to OECD 423 test guideline, an LD50 >2000 mg/kg bw was determined for NS-3000.
- Executive summary:
The acute oral toxicity of NS-3000 was determined in accordance with OECD 423 guideline and according to GLP principles.
NS-3000 was administered to six female rats by a single dose of 2000 mg/kg bodyweight (2 groups of three females in a stepwise manner). All animals survived to the scheduled necropsy (study day 14). There were no clear test substance-related clinical observations. The only clinical observation was soft feces for 1 female on study day 0 (15 minutes and 4 hours post-dosing). There were no remarkable body weight changes noted during the study. There were no test substance-related macroscopic findings at the scheduled necropsy. The only gross lesion observed was an enlarged pituitary gland for one female. Based on the results of this study, the estimated LD50 of NS-3000 was greater than 2000 mg/kg body weight and the substance does not need to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging.
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.
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