Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2012-04-19 to 2012-05-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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.: 111202
Purity: 95.5%
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl:CD ‘SD’)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately eight to twelve weeks
- Weight at study initiation: 199 to 250 g
- Fasting period before study: yes, overnight
- Housing: housed in groups of up to three rats of the same sex, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding.
- Diet: free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet), except for overnight prior to and approximately four hours after dosing.
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air: 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
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5 and 30 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bodyweight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose levels for the study were chosen in compliance with the study guidelines. Based on information provided by the Sponsor the initial dose was 50 mg/kg. - Doses:
- 50 and 300 mg/kg
- No. of animals per sex per dose:
- 6 females for 50 mg/kg, 3 females for 300 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality: at least twice daily
- Clinical observations: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, surviving animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity, where appropriate, of the clinical signs and the time were recorded at each observation.
- Bodyweight: recorded on Days 1 (prior to dosing), 8 and 15 or at death
- Necropsy of survivors performed: yes, All surviving animals were humanely killed on Day 15 by carbon dioxide asphyxiation and subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two females (2/3) dosed at 300 mg/kg were found dead or died on Day 2.
Clinical signs prior to death comprised piloerection, loose faeces, underactive behaviour, hunched posture, increased body tone all seen in both decedents, in addition salivation, reduced body tone, irregular breathing, deep breathing, unsteady gait, unresponsive behaviour were all seen in one decedent. These signs were seen from approximately 30 minutes after dosing. A loss in bodyweight was noted for both decedents. Macroscopic examination of the decedents revealed congestion (characterised by darkened tissues/organs) of the subcutaneous tissue, heart, liver, spleen and kidneys, small (atrophy) ceacum and yellow/clear fluid contents seen in the stomach, duodenum, small intestines and large intestines and were seen in all decedents. Pallor of the lungs was noted in one decedent. - Clinical signs:
- other: Clinical signs of reaction to treatment in the surviving animal dosed at 300 mg/kg comprised piloerection, loose faeces, underactive behaviour, hunched posture, salivation, increased body tone, reduced body tone , partially closed eyelids, red staining on
- Gross pathology:
- Macroscopic examination at study termination on Day 15 revealed a small (atrophy) stomach in two females dosed at 50 mg/kg and pallor of the kidneys in one animal treated at 300 mg/kg. No abnormalities were revealed in any other animal at the macroscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of test item was demonstrated to be between 50 and 300 mg/kg bodyweight.
- Executive summary:
The acute oral toxicity of test item to the rat was assessed based on the method as described in OECD 423.
Two groups of three fasted female rats received a single oral gavage dose of the test substance, formulated in dried corn oil, at a dose level of 50 mg/kg bodyweight. As results at this dose level indicated the acute (median) lethal oral dose of the test substance to be greater than 50 mg/kg bodyweight, in compliance with the study guidelines a further group of three fasted females were similarly dosed at 300 mg/kg bodyweight to complete the study.
Two females dosed at 300 mg/kg were found dead or died on Day 2. Clinical signs prior to death comprised piloerection, loose faeces, underactive behaviour, hunched posture, increased body tone all seen in both decedents, in addition salivation, reduced body tone, irregular breathing, deep breathing, unsteady gait, unresponsive behaviour were all seen in one decedent. These signs were seen from approximately 30 minutes after dosing. A loss in bodyweight was noted for both decedents. Macroscopic examination of the decedents revealed congestion (characterised by darkened tissues/organs) of the subcutaneous tissue, heart, liver, spleen and kidneys, small (atrophy) ceacum and yellow/clear fluid contents seen in the stomach, duodenum, small intestines and large intestines and were seen in all decedents. Pallor of the lungs was noted in one decedent.
Clinical signs of reaction to treatment in the surviving animal dosed at 300 mg/kg comprised piloerection, loose faeces, underactive behaviour, hunched posture, salivation, increased body tone, reduced body tone , partially closed eyelids, red staining on fore paws and head, unsteady gait, wet urine staining (ventral) and hairloss (perigenital area). These signs were first noted approximately from 30 minutes to three hours after dosing.
Piloerection was seen in three females dosed at 50 mg/kg. These signs were first noted approximately from three hours after dosing. No clinical signs were seen in the remaining three animals dosed at 50 mg/kg.
A low bodyweight gain was noted for one female dosed at 50 mg/kg on Day 15. All other surviving animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Macroscopic examination at study termination on Day 15 revealed a small (atrophy) stomach in two females dosed at 50 mg/kg and pallor of the kidneys in one animal treated at 300 mg/kg. No abnormalities were revealed in any other animal at the macroscopic examination at this time.
The acute median lethal oral dose (LD50) to rats of test item was demonstrated to be between 50 and 300 mg/kg bodyweight.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.