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EC number: 435-300-4 | CAS number: 82113-65-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, OECD 423 compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 435-300-4
- EC Name:
- -
- Cas Number:
- 82113-65-3
- Molecular formula:
- C2HNO4F6S2
- IUPAC Name:
- 1,1,1-trifluoro-N-trifluoromethanesulfonylmethanesulfonamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.l., Correzzana (Ml), Italy.
- Age at study initiation: 5 to 6 weeks old
- Weight at study initiation: 126 to 150 grams
- Fasting period before study: one overnight
- Housing: in groups of up to 5 animals of the same sex, in polycarbonate cages measuring 59x20x39 cm and equipped with a stainless steel mesh lid and floor.
- Diet (e.g. ad libitum): a commercially available laboratory rodent diet (Altromin MT, A. Rieper S.p.A., Bolzano, Italy) ad libitum throughout the study
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark each day.
IN-LIFE DATES: From 04/08/1999 to 11/11/1999
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD
- Rationale for the selection of the starting dose: in a previous study, doses of 500 and 200 mg/kg were tested with 100% mortality. That's why the starting dose of 25 mg/kg was chosen.
MAIN STUDY:
The study progressed in a stepwise manner as follows:
A group of 3 male animals was dosed at a fixed level of 25 mg/kg body weight. No animal died or exhibited significant toxicity. As a result, a second group of 3 female animals was dosed at the same level. None of these animals died or exhibited significant toxicity.
Three male animals were dosed at a higher level of 200 mg/kg. All animals showed significant toxicity and died following dosing.
Following this, an additional group of 3 males was dosed at an intermediate level of 50 mg/kg. None of the animals died or exhibited significant toxicity. This finding was confirmed by dosing a group of 3 females at the same level. - Doses:
- 25, 50 and 200 mg/kg
- No. of animals per sex per dose:
- 3 males and 3 females at 25 and 50 mg/kg
3 males at 200 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Throughout the study all animais were checked twice daily. All animals were weighed on allocation to the study (Day -1) and immediately prior to dosing (Day 1). Surviving animals were weighed on Days 8 and 15. Animals found dead were weighed when found.
- Necropsy of survivors performed: yes
All surviving animals were killed on Day 15 by carbon dioxide narcosis. Animais killed in this way and those dying during the study were subjected to a gross necropsy exarnination for both extemal and internal abnormalities. The cranial, thoracic and abdominal cavities were opened to allow examination of their contents. Larger organs were sectioned. Both the stomach and representative sections of the gastro-intestinal tract were opened for examination of the mucosal surfaces.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/6 at 25 and 50 mg/kg.
3/3 at 200 mg/kg. - Clinical signs:
- other: 25 mg/kg: staining of the skin/fur was noted in 2 animals following dosing. This was no longer apparent after 3 days. 200 mg/kg: All animals exhibited salivation, pallor, lethargy and tremors within approximately 1 hour of dosing. Two animals were uncons
- Gross pathology:
- 25 mg/kg: examination revealed no abnormal findings.
200 mg/kg: examination revealed staining of the skin/fur of the muzzle and, in 1 animal, around the urogenital region. A pale area was noted on the gladular region of the stomach of 1 animal and the lungs of this animal were abnormally dark and not collapsed as expected. A red or white mucoid material was found in the jejunum of all 3 animals.
50 mg/kg: No abnormalities were found on necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- TFSIH is toxic by ingestion and classified Acute oral toxicity Category 3 (H301) according to the CLP 1272/2008 criteria.
- Executive summary:
The acute toxicity of bis-trifluoromethane sulfonimide (TFSIH) was investigated following administration of a single oral dose to the rat. The study proceeded in a stepwise manner as follows:
A group of 3 male animals was dosed at a fixed level of 25 mg/kg body weight. No animal died or exhibited significant clinical signs. This was confirmed by dosing a second group of 3 female animals at the same level. None of these animals died or exhibited significant toxicity.
Three male animals were dosed at a higher level of 200 mg/kg. All animals exhibited significant toxicity and died within 24 hours. Three additional males were dosed at an intermediate level of 50 mg/kg. No animal died or exhibited significant clinical signs following dosing. This finding was confirmed by dosing a second group of 3 female animals at the same level. None of these animals died or exhibited significant toxicity.
These results indicate that the test substance has a significant toxic effect in the rat following oral administration of a single dose. The observed toxicity indicates the median lethal dose (LD50) to be greater than 50 mg/kg but less than 200 mg/kg.
In these conditions, TFSIH is toxic by ingestion and classified Acute oral toxicity Category 3 (H301) according to the CLP 1272/2008 criteria.
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