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EC number: 220-877-5 | CAS number: 2923-16-2
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 05 oct 2011 to 30 dec 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, OECD 429 compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 19 july 2011
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Potassium trifluoroacetate
- EC Number:
- 220-877-5
- EC Name:
- Potassium trifluoroacetate
- Cas Number:
- 2923-16-2
- Molecular formula:
- C2HF3O2.K
- IUPAC Name:
- potassium trifluoroacetate
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: animals of the preliminary test were approximately 10 weeks old and the animals of the main test were approximately 8 weeks old.
- Weight at study initiation: mean body weight of 21.6 g (range: 19.8 g to 23.8 g).
- Housing: The animals were housed by group of two (preliminary test) or four (main test) in polycarbonate cages (Techniplast 1145T, 435 cm2, 36.9 x 15.6 x 13.2 cm) containing autoclaved sawdust (SICSA, Alfortville, France).
Each cage contained two enrichments (mouse hut and cocoon) with possibility of rotation during the study.
In the main test, on day 6 before the 3H-TdR injections, the animals were individually housed in disposable crystal polystyrene cages (22.0 cm x 8.5 cm x 8.0 cm).
- Diet (e.g. ad libitum): All animals had free access to SSNIFF R/M-H pelleted maintenance diet, batch Nos. 9615507 and 7055973, (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): All animals had free access to tap water (filtered using a 0.22 micron filter) contained in bottles.
- Acclimation period: the animals were acclimated to the study conditions 8 (preliminary test) or 13 (main test) days before the beginning of the treatment period. At the end of acclimation period, the required number of animals was selected according to clinical condition and body weight.
ENVIRONMENTAL CONDITIONS
Temperature: 22 ± 2°C,
Relative humidity: 50 ± 20%,
Light/dark cycle: 12 h/12 h (7:00 - 19:00),
Ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
IN-LIFE DATES: From: 02 nov 2011 To: 14 nov 2011
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 2.5, 5, 10, 25 and 50%
- No. of animals per dose:
- 4 females per dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: As unsatisfactory solubility of the test item was obtained in AOO (i.e. heterogeneous preparation to the naked eye at the concentration of 50% was obtained), dimethylformamide (DMF), batch No. SZBA1190, supplied by Sigma, was used.
A solution was obtained at the concentration of 50% in DMF.
- Irritation: No local reactions were noted in any animals.
No notable increase in ear thickness was observed in any group.
The highest concentration retained for the main test was therefore 50%.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: pooled method
- Criteria used to consider a positive response: The test item is considered as a skin sensitizer when the SI for a dose group is >= 3 together with consideration of a dose-response relationship. Other relevant criteria such as radioactivity levels and ear thickness are also taken into account to evaluate the data.
TREATMENT PREPARATION AND ADMINISTRATION:
Application:
On days 1, 2 and 3, a dose-volume of 25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.
In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthesia during the administration.
No massage was performed but the tip was used to spread the preparation over the application site. No rinsing was performed.
AURICULAR LYMPH NODE CELL (ALNC) PROLIFERATION ASSAY
Intravenous injection of 3H-TdR and sampling of auricular lymph nodes:
Lymph node cell proliferative response was measured as described by Kimber and Dearman (1). On day 6 of the main test, all animals of all groups received a single intravenous injection of 250 µL of 0.9% NaCl containing 20 µCi of 3H-TdR (specific activity of 20 Ci/mmol) via the tail vein.
Approximately 5 hours later, the main test animals were sacrificed by an intraperitoneal injection of pentobarbital sodium followed by a cervical dislocation and the auricular lymph nodes were excised. The lymph nodes were pooled for each experimental group. A single cell suspension of ALNC was prepared by mechanical disaggregation in Petri dishes with the plunger of a syringe.
Preparation of auricular lymph node cell suspensions and determination of proliferation:
Cell suspensions were washed once with 15 mL of 0.9% NaCl. Each cell suspension was then centrifuged and pellets were precipitated with 3 mL of 5% (w/v) trichloroacetic (TCA) at +4°C overnight. After a last centrifugation, the pellets were precipitated with 1 mL of 5% TCA. Three millilitres of Ultima GoldxR scintillation fluid (Packard) were added in order to measure incorporation of 3H-TdR using beta-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The threshold positive value of 3 for the SI was exceeded in the positive control group (SI = 12.16). The experiment was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.46
- Test group / Remarks:
- Test item 2.5%
- Remarks on result:
- other:
- Parameter:
- SI
- Value:
- 1.72
- Test group / Remarks:
- Test item 5%
- Parameter:
- SI
- Value:
- 2.61
- Test group / Remarks:
- Test item 10%
- Parameter:
- SI
- Value:
- 0.57
- Test group / Remarks:
- Test item 25%
- Parameter:
- SI
- Value:
- 2.05
- Test group / Remarks:
- Test item 50%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 391.5
- Test group / Remarks:
- Test item 2.5%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 272.88
- Test group / Remarks:
- Test item 5%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 415
- Test group / Remarks:
- Test item 10%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 90.38
- Test group / Remarks:
- Test item 25%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 325.13
- Test group / Remarks:
- Test item 50%
Any other information on results incl. tables
The acceptance criterion was met; this experiment was therefore considered valid.
The results are presented in the following table:
Treatment |
Concentration (%) |
Irritation level |
Stimulation Index (SI) |
Test item |
2.5 |
non-irritant |
2.46 |
Test item |
5 |
non-irritant |
1.72 |
Test item |
10 |
non-irritant |
2.61 |
Test item |
25 |
non-irritant |
0.57 |
Test item |
50 |
slightly irritant |
2.05 |
HCA |
25 |
- |
12.16 |
No notable lymphoproliferation was noted with the test item at any tested concentrations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Potassium trifluoroacetate, did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
- Executive summary:
The objective of the study was to evaluate the potential of the test item, Potassium trifluoroacetate, to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA). Evaluation of local irritation was also carried out in parallel.
Two groups of two female mice received the test item, Potassium trifluoroacetate, by topical route to the dorsal surface of both ears (one concentration per ear) on days 1, 2 and 3 at concentrations of 5, 10, 25 or 50 % under a dose-volume of 25 µL. From day 1 to day 3 then on day 6, the thickness of both ears of each animal was measured and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6. On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination.
In the main test, five groups of four female mice received the test item by topical route to the dorsal surface of both ears on days 1, 2 and 3 at concentrations of 2.5, 5, 10, 25 or 50% under a dose‑volume of 25 µL. One negative control group of four females received the vehicle (dimethylformamide) under the same experimental conditions. Additionally, one positive control group of four females received the positive control, α‑hexylcinnamaldehyde (HCA), at 25% in a mixture acetone/olive oil (4/1; v/v) under the same experimental conditions.
From day 1 to day 3 then on day 6, the thickness of the left ear of each animal was measured, except in animals of the positive control group, and the local reactions were recorded. Each animal was observed once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6.
After 2 days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3H-TdR. The results were expressed as disintegrations per minute (dpm) per group and as dpm/node. The obtained values were used to calculate Stimulation Indices (SI).
No deaths related to the treatment with the test item and no clinical signs were observed during the observation period.
In the main test, dryness of ear skin was noted in all females treated at 10% on day 6. An increase in ear thickness of 14.43% was observed in females treated at 50%. The threshold positive value of 3 for the SI was exceeded in the positive control group (SI = 12.16). The experiment was therefore considered valid. To assess the irritant potential of the test item (through ear thickness measurement), a preliminary test was first performed in order to define the test item concentrations to be used in the main test. No relevant increase in ear thickness was observed in the other test item-treated groups.
Under the experimental conditions of this study, the test item, Potassium trifluoroacetate, did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
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