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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Simplified study not GLP, following standardised guidelines.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- less animals than recommended in the guideline were used
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
No more information available.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Induction 1% in polyethyleneglycol 400
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Induction 1% in polyethyleneglycol 400
- No. of animals per dose:
- 3 in the control group
5 in the test group - Details on study design:
- RANGE FINDING TESTS:
In a preliminary screening test, necrosis was evident by intradermal injection of the tets substance up to a concentration 0.5% and slight irritation (score of 1) was observed after topical application at a concentration of 25%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week (1st induction) and 2 weeks (2nd induction).
- Test groups: 1
- Control group: only vehicles
- Frequency of applications: second induction 1 week after the first one.
- Duration: 3 weeks
- Concentrations: 1% in polyethylene 400 and 1% in FCA emulsion for intradermal injection. 25% in petrolatum for topical application.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 2weeks after the second induction.
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Concentrations: 10% in petrolatum (1st challenge); 1% in petrolatum (re-challenge)
- Evaluation (hr after challenge):
Animals were allocated to treatment to give a test group of 5 animals and a control group of 3. In an attempt to induce sensitization, test animals were intradermally injected with an emulsion of FCA and the test substance in both the selected vehicle and FCA emulsion.
One week later this was boosted by topical application of the test substance over the injection sites. Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance.
Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. Irritation to the test substance was noted and challenge was repeated 1 week later using the test substance at lower concentration.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Swelling of treated skin; desqamation from skin surface
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Swelling of treated skin; desqamation from skin surface.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Results:
1st challenge |
||
Control group |
||
Animal Number |
Reaction at challenge |
|
24 hours |
48 hours |
|
93 |
1 |
1 |
95 |
1 |
1 |
97 |
1 |
1s |
Test group |
||
Animal number |
Reaction at challenge |
|
24 hours |
48 hours |
|
99 |
1ds |
2n |
101 |
1ds |
2n |
103 |
1s |
2t |
105 |
1s |
2t |
107 |
1s |
1 |
(s) Swelling of treated skin; (d) desqamation from skin surface; (t) Thickening of treated skin
2nd challenge |
||
Control group |
||
Animal Number |
Reaction at challenge |
|
24 hours |
48 hours |
|
93 |
0 |
0 |
95 |
0 |
0 |
97 |
0 |
0 |
Test group |
||
Animal number |
Reaction at challenge |
|
24 hours |
48 hours |
|
99 |
0 |
0 |
101 |
0 |
0 |
103 |
0 |
0 |
105 |
0 |
0 |
107 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- TFSIH is not sensitizing.
- Executive summary:
In a study (2000), animals were allocated to treatment to give a test group of 5 animals and a control group of 3 animals. In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites.
Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. Irritation to the test substance was noted and challenge was repeated 1 week later using the test substance at a lower concentration.
The concentrations of the test substance used were determined by preliminary screening tests, in which necrosis was evident by intradermal injection of the test substance up to a concentration 0.5% and a slight irritation (score of 1) was observed after topical application at a concentration of 25%.
These results indicate that the test substance does not elicit a sensitisation response in the guinea pig, there being no evidence of reaction at challenge following a period of induction exposure to the substance.
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