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Diss Factsheets
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EC number: 251-528-5 | CAS number: 33454-82-9
- 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:
- weight of evidence
- Study period:
- From 28-February-2000 to 19-August-2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well documented study according to OECD TG 406 performed by trusted laboratory. However, since the study was a simplified study and not performed under GLP conditions, the Klimisch score is 2.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation, other
- Remarks:
- Based on both LLNA and GPMT assays
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- See attached justification document
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- other: Global evaluation
- Remarks on result:
- no indication of skin sensitisation
- Parameter:
- SI
- Value:
- < 3
- Remarks on result:
- other: See remarks
- Remarks:
- Negative
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 5 animals in treated groups / 3 animals in control group / Only two intradermal injection during the induction phase
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed before Reach regulation ((EC) No. 1907/2006).
Test material
- Reference substance name:
- bismuth;trifluoromethanesulfonate
- Cas Number:
- 88189-03-1
- Molecular formula:
- C3BiF9O9S3
- IUPAC Name:
- bismuth;trifluoromethanesulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature, under a dry inert atmosphere
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l.
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Housing: Not specified
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): Not specified
- Acclimation period: Not specified
- Indication of any skin lesions: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5%
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 50%
- Route:
- other: Topical application / Second induction stage
- Vehicle:
- water
- Concentration / amount:
- 60%
- Adequacy of induction:
- other: non-irritant substance, but skin pre-treated with SDS
Challenge
- No.:
- #1
- Route:
- other: Topical application
- Vehicle:
- water
- Concentration / amount:
- 30%
- No. of animals per dose:
- 5 animals in the test group
3 animals in the control group - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Preliminary screens
This following table details the results of examination of injection sites 6 days after intradermal injection of a range of concentrations of the test item.
Animal number | Test item concentration |
Erythema | Additional comments |
281 | 50% 20% 10% 5% 1% 0.5% |
- - - - - 2 |
Necrosis Necrosis Necrosis Necrosis Necrosis None |
This following table details the results of examination of treated sites following topical application of a range of concentrations of the test item.
Animal number | Observation time | Test item concentration | |||
60% | 30% | 10% | 5% | ||
285 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
287 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the maximisation test in Guinea pig did not show any evidence of reaction at challenge. Therefore, the test item, bismuth triflate, should not be considered as a skin sensitizer.
- Executive summary:
In a non-GLP skin sensitisation study performed similarly to the OECD No. 406 (screening test), Dunkin-Hartley guinea pigs were exposed to bismuth triflate diluted in sterile water (vehicle). In a preliminary study the skin irritation potential of the test item was assessed in one animal after an intradermal injection with Freund’s complete adjuvant and on two animals following a topical application in order to determine the concentrations of test item used in the main study.
In the main study performed on 5 animals for the test group and 3 animals for the control group. In the first induction stage intradermal injections of Freund’s complete adjuvant (FCA), or of the test item (50%) with FCA, or of the test item (0.5%) in vehicle were performed on each animal. One week later, the animals were pre-treated with sodium lauryl sulphate (to promote a skin irritation) and then topically exposed to the test item at 60% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (30%) in water. 24 and 48 hrs after the challenge, no skin reaction was observed in any animal of the test group or of the control group. The body weight gain was comparable in the test animals and the control animals.
In conclusion, under the test conditions, the test item, bismuth triflate, should not be considered as a skin sensitizer.
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