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EC number: 826-676-4 | CAS number: 521065-36-1
- 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 2014-03-04 to 2014-04-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Lithium [ethanedioato-O,O’]tetrafluorophosphate
- EC Number:
- 826-676-4
- Cas Number:
- 521065-36-1
- Molecular formula:
- LiPF4C2O4
- IUPAC Name:
- Lithium [ethanedioato-O,O’]tetrafluorophosphate
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 140116
Purity: 99.8 wt%
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK
- Females nulliparous and non-pregnant: not specified]
- Age at study initiation: approximately eight to ten weeks
- Weight at study initiation: 17.7 to 20.3 g
- Housing: housed two animals per cage, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding, additionally Nestlets and a plastic shelter were included for environmental enrichment.
- Diet: standard rodent diet (Rat and Mouse No. 1 Maintenance Diet, ad libitum
- Water: Potable water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes: The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1, 2.5 and 5% w/v in AOO
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: A vehicle trial performed with LiPF4(OX) showed that it formed a fine off-white suspension, (nearly in solution) at 50% w/v in AOO and a pale yellow solution at 5% w/v and below in AOO.
- Irritation:
10% w/v: Slight erythema was observed on the ears of both mice on Day 3.
5% w/v: No erythema was observed on either mouse throughout the study.
- Systemic toxicity:
10% w/v: Both animals were terminated on Day 3 due to the severity of clinical signs seen these included, under activity, fasciculation’s (whole body), irregular breathing, unsteady gait, reduced body temperature, flat posture, shallow breathing, partially closed eyelids, cloudy discharge from eyes and gasping.
5% w/v: There were no deaths and no signs of ill health or toxicity were observed during this study. Greasy fur on the head was noted following each dosing occasion, this was related to unoccluded dermal administration of a liquid formulation/vehicle and not an effect of the test substance.
- Body weight:
- Ear thickness measurements: A marked loss in body weight was noted for both mice dosed at 10% w/v and a slight loss for both mice dosed at 5% w/v over the study period.
10% w/v: Due to signs of toxicity animals were terminated before the end of the study so no measurements were made on Day 6.
5% w/v: There was no evidence of an effect of treatment on ear thickness
- Erythema scores: 0for all animals tested at 5% w/v. 1 for all animals tested at 10% w/v at Day 3.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: local lymph node assay (LLNA)
- Criteria used to consider a positive response: If the SI is 3 or more, the test substance is regarded as a skin sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION:
- Test Formulation:
The test substance was prepared for administration as a series of graded concentrations in the vehicle, by direct dilution.
- Administration of test substance:
Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 μL of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3). The test substance was applied to the dorsal surface of each ear using a microlitre syringe and was spread over the entire dorsal surface of the ear using the tip of the syringe.
- Administration of 3H-methyl Thymidine:
Five days following the first topical application of test substance (Day 6) all mice were injected via the tail vein with 250 μL of phosphate buffered saline containing 3H-methyl Thymidinea (3HTdR: 80 μCi/mL) giving a nominal 20 μCi to each mouse. The injection into the tail vein was carried out using a plastic syringe and needle after the mouse had been heated in a warming chamber.
OBSERVATIONS
- Clinical signs: observed daily
- Body weight: recorded on arrival (data not reported), Day 1 (before dosing) and prior to termination (Day 6) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The SI for the positive control substance hexyl cinnamic aldehyde (HCA) was 9.3.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 5.9
- Test group / Remarks:
- 1% w/v
- Parameter:
- SI
- Value:
- 22.3
- Test group / Remarks:
- 2.5 % w/v
- Parameter:
- SI
- Value:
- 21.8
- Test group / Remarks:
- 5% w/v
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DETAILS ON STIMULATION INDEX CALCULATION
This was derived by dividing the mean dpm/mouse for each treated group and the positive control group by the mean dpm/mouse in the vehicle control group.
EC3 CALCULATION
EC3 value was extrapolated from the two lowest doses utilized according to the following formula:
EC3ex = 2^{log2(c) + (3 - d) / (b - d) x [log2(a) - log2(c)]}
Where a = concentration giving SI greater than 3
b = SI at concentration a
c = concentration giving SI less than 3
d = SI at concentration c.
The EC3 value is calculated to be 0.9% w/v.
CLINICAL OBSERVATIONS:
There were no deaths and no signs of ill health or toxicity were observed during this study. Wet/greasy fur on the head was noted following each dosing occasion, this was related to unoccluded dermal administration of a liquid formulation/vehicle and not an effect of the test substance.
BODY WEIGHTS
There was no indication of an effect of treatment on body weight gain.
A loss in body weight was noted for one mouse dosed at 2.5% w/v and one mouse dosed at 5% w/v over the study period, however, a small loss in body weight is not uncommon in young laboratory mice and is not considered to be an effect of treatment.
DERMAL REACTIONS
No signs of dermal irritation were seen on the ear during the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item is regarded as a potential skin sensitizer. The EC3 value was calculated to be 0.9% w/v.
- Executive summary:
The skin sensitization potential of test item was assessed using the local lymph node assay (LLNA) according to OECD 429.
The study comprised three treated groups, each comprising four female mice receiving test item at concentrations of 1, 2.5 or 5% w/v. The mice were treated by daily application of 25 μL of the appropriate concentration or control (vehicle or positive), to the dorsal surface of both ears for three consecutive days.
The SI obtained for 1, 2.5 and 5% w/v were 5.9, 22.3 and 21.8 respectively which indicates that the test item showed the potential to induce skin sensitization.
The EC3 value was calculated to be 0.9% w/v.
The test item is regarded as a potential skin sensitizer. The EC3 value was calculated to be 0.9% w/v.
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