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EC number: 216-087-5 | CAS number: 1493-13-6
- 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:
- From 13 October 1987 to 4 November 1987.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study performed similarly to OECD guideline No. 401 but no data on GLP compliance. Only males are tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Kanpogyo Notification No. 39, Yakuhatsu Notification No. 229, and 59 Kikyoku Notification No., 85, dated 31 March 1984
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Trifluoromethanesulphonic acid
- EC Number:
- 216-087-5
- EC Name:
- Trifluoromethanesulphonic acid
- Cas Number:
- 1493-13-6
- Molecular formula:
- CHF3O3S
- IUPAC Name:
- trifluoromethanesulfonic acid
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Trifluoromethanesulfonic acid.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar Kyoto (WKY)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals
- Age at study initiation: 5 weeks
- Weight at study initiation: 108.7 +/-3.4 g
- Fasting period before study: 17 hours prior to administration
- Housing: by groups of 5 in 310 mm W x 400 mm D x 200 mm H cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25°C
- Humidity (%): 45-65%
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark /12 hrs light
IN-LIFE DATES: From: 13 October 1987 To 4 November 1987.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: see Table 7.2.1/1
- Amount of vehicle (if gavage): 1 mL/100 g
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: no data
DOSAGE PREPARATION:
The test substance was diluted with distilled water to prepare the administration solutions at the prescribed concentrations as needed
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
As a preliminary test, 3 to 4 animals were administered 2000 and 500 mg/kg of the test substance. 3 of the 4 cases in the 2000 mg/kg group died, but no deaths were observed in the 500 mg/kg administration group. Based on these results, a dosage of 700 mg/kg was used as the standard and a common ratio of 1.3 established to set dosages within the range of 539 to 2000 mg/kg bw. - Doses:
- 0, 539, 700, 910, 1183, 1538 and 2000 mg/kg bw.
- No. of animals per sex per dose:
- 10 males/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for death or overt signs of toxicity several times on the day of administration, and then at least once per day from the following day onward. Individual bodyweights were recorded prior to dosing on Day 0 and on days 3, 7, 10 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weigh and histopathology - Statistics:
- LD50 value was calculated by the Probit method. The weights of the administration groups with at least 2 survival cases were assayed by determining the difference in average values between the control group and each administration group by means of a Student’s t-test or Welch’s test.
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 605.3 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 402.1 - <= 1 941.8
- Mortality:
- - At 2000 mg/kg: 7/10 of dead animals
- At 1538 mg/kg: 6/10 of dead animals
-At 1183 mg/kg: 1/10 of dead animals
- At 910, 700 and 539 mg/kg: 0/10 of dead animals for each tested doses. - Clinical signs:
- other: - At 2000 and 1538 mg/kg: decrease in spontaneous movement, crawling, sedation and emaciation were observed. - At 1183 and 910 mg/kg: decrease in spontaneous movement and sedation were observed - At 700 and 539 mg/kg: decrease in spontaneous movement was
- Gross pathology:
- - The necropsies of the fatal cases revealed gastric hemorrhaging, perforation, clouding and hyperemia of the small intestine, blackening and hypertrophy of the spleen, petechial hemorrhaging of the thymus, hemorrhaging of the bladder, and increase in pleural effusion.
- The necropsies of the survival cases revealed gastric erosion, scarring, thickening, adhesion of the stomach and liver, and thickening of the duodenum in the groups administered 1183 mg/kg or more. - Other findings:
- - Histopathology:
Histopathological examinations revealed submucosal cellular infiltration in the stomach and small intestine. In strongly stimulated cases, adhesion of the stomach and liver reaching the muscle layer, serous membrane, and outside the serous membrane was observed. An extreme decrease in lymphocytes in the spleen was also observed.
Any other information on results incl. tables
Table 7.2.1/2: Autopsy findings in male rats treated with trifluoromethanesulfonic acid:
Dose (mg/kg) |
0 |
539 |
700 |
910 |
1183 |
1538 |
2000 |
No. Of rats used |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
No. Of rats found dead |
0 |
0 |
0 |
0 |
1 |
6 |
7 |
FINDINGS |
|||||||
Thymus: -Petechia |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
Stomach: -Perforation -Hemorrhage |
0 |
0 |
0 |
0 |
0 1 |
5 5 |
4 7 |
Small intestine: -Cloudy white -hyperemia |
0 |
0 |
0 |
0 |
0
0 |
0
0 |
3
3 |
Spleen: -Hypertrophy -Black in color |
0 |
0 |
0 |
0 |
0 0 |
0 0 |
2 3 |
Urinary bladder: -Hemorrhage -Pleural effusion increase |
0 |
0 |
0 |
0 |
0 0 |
0 4 |
1 4 |
Advanced autolysis |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
Terminal killed |
|
|
|
|
|
|
|
Stomach: -Erosion -Scar -Thickening |
0 |
0 |
0 |
0 |
0 0 7 |
3 1 4 |
0 1 3 |
Stomach and liver: -Adhesion |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
Duodenum: -Thickening -No abnormalities detected |
0 10 |
0 10 |
0 10 |
0 10 |
4 2 |
1 0 |
1 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the test conditions of this study, the acute median lethal dose (LD50) of trifluoromethanesulfonic acid was 1605.3 mg/kg body weight in the Wistar Kyoto (WKY) strain male rat. Based on this result, trifluoromethanesulphonic acid is classified as Harmful if swallowed in category 4, H302 according to the regulation (EC) No. 1272/2008 (CLP) and as Xn-R22 according to Annex VI of the Directive 67/548/EEC.
- Executive summary:
In an acute oral toxicity study (KOBAYASHI, 1988) performed similarly to OECD guideline N° 401, groups of fasted Wistar Kyoto male rats (10/dose) were given a single oral dose of trifluoromethanesulphonic acid by gavage at the doses of 0 (vehicle only), 539, 700, 910, 1183, 1538 and 2000 mg/kg bw and observed for 14 days. Mortality and clinical signs were checked just after administration at 1, 2, 6 hours after dosing, and daily for 14 days. Body weight was recorded on days 0, 1, 2, 4, 7 and 14.
No males died at 539, 700 and 910 mg/kg bw whereas 1/10, 6/10 and 7/10 animals died when dosed at 1183, 1538 and 2000 mg/kg bw respectively.
Decrease in spontaneous movement, crawling, sedation and emaciation were observed but they were reversible.
All animals treated at 1183 mg/kg bw and more showed suppression of weight gain during the study.
Gastric erosion, scarring, thickening, adhesion of the stomach and liver and thickening of the duodenum were observed at necropsy. Histopathological examinations revealed submucosal cellular infiltration in the stomach and small intestine. In strongly stimulated cases, adhesion of the stomach and liver reaching the muscle layer, serous membrane, and outside the serous membrane was observed. An extreme decrease in lymphocytes in the spleen was also observed.
Under the conditions of this test, the Oral LD50 male rats = 1605.3 mg/kg (with 1402.1-1941.8 95% C.I.).
Based on these results, trifluoromethanesulphonic acid is considered as harmful if swallowed in category 4; H302 according to the regulation (EC) No. 1272/2008 (CLP) and as Xn, R22 according to the directive 67/548/EEC.
This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study in the rats.
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