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EC number: 695-938-6 | CAS number: 678966-16-0
- 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:
- 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Lithium bis[ethanedioato(2-)-κO1,κO2]difluorophosphate(1-)
- EC Number:
- 695-938-6
- Cas Number:
- 678966-16-0
- Molecular formula:
- F2C4PLiO8
- IUPAC Name:
- Lithium bis[ethanedioato(2-)-κO1,κO2]difluorophosphate(1-)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age at First Dose 8 - 12 weeks; female animals were non-pregnant and nulliparous
Animal Health The health condition of animals was examined by a veterinarian
before initiation of the study.
Acclimation The animals were acclimated to the condition identical to the condition during the experiment at least 5 days prior to the start of treatment. The acclimation was according to standard operation procedures.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage, in a room equipped with central air-conditioning. The room temperature was maintained within the range of 22 ± 2 °C. The relative humidity will be 55 ± 10 %. The light regime was set to a 12-hour light / 12-hour dark cycle. The sanitation was performed according to standard operation procedures.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- olive oil
- Details on oral exposure:
- Diet A standard laboratory food KKZ-P/M (UEFT CEM SAS) was available ad libitum. The certificate of analysis is included in the raw data.
Water The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is periodical monitored (including microbiological control) and recorded; certificate of analysis is included in raw data.
Bedding AlpenSpan Eco, Johann Pabst Holzindustrie GmbH, Zeltweg, Austria
Animals Identification Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in cages were marked by a line on the tail with an ink marker. - Doses:
- The starting dose can be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item was likely to be non-toxic regarding acute toxicity therefore we chose a dose of 2000 mg Lithium difluorobis(oxalate)phosphate/kg body weight to be used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose caused mortality of all three animals within 48 hours after administration. In a second step, 3 females were treated at dose of 300 mg/kg body weight. Test item-related mortality was not observed for 48 hours and therefore, in a third step, another 3 females were treated at the same dose level.
- No. of animals per sex per dose:
- 15
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Clinical signs:
- other: Mortality of 3/3 females at limit dose of 2000 mg/kg body weight was observed. Four out of six female animals survived and two animals (Animal No 8 and No 9) died 2-4 hours after administration at the dose of 300 mg/kg body weight. No animal died after do
- Other findings:
- All animals were necropsied. In animals No 1 - 3 dosed with 2000 mg/kg body weight we did not observe obvious pathological changes. No visible pathological findings were observed in animals dosed with 300 mg/kg and 50 mg/kg body weight except hyperemia of gastric corpus in Animal No 6. All necropsy results are in Table 6.
Any other information on results incl. tables
Table1.Clinical observation - 2000 mg/kg body weight, Animal No 1-3.
Observation |
Time After Administration |
||||||||||||||||||
Hour |
Day |
||||||||||||||||||
I |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
Skin and Hair** |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
1,2,3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
1,2,3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Tremor |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
1,2,3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
1,2,3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sacrificed |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Others |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- No observed signs, I - immediately. * - dyspnoe, ** - vein vasodilatation in hindlimb soles and tail
Sex |
Dose |
ID |
Administration Result |
Clinical Observation |
♀ |
2000 mg/kg |
1 |
death |
- lethargy and sleep/sedative behavior immediately after administration of test item, ½ an hour later: death of animal |
2 |
death |
- lethargy and sleep/sedative behavior immediately after administration of test item, ½ an hour later: death of animal |
||
3 |
death |
- lethargy and sleep/sedative behavior immediately after administration of test item, ½ an hour later: death of animal |
Table 2.Clinical observation - 300 mg/kg body weight, Animal No 4-9.
Observation |
Time After Administration |
||||||||||||||||||
Hour |
Day |
||||||||||||||||||
I |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
Skin and Hair** |
-- |
4,5,6 7,8,9 |
4,5,6 7,8,9 |
4,5,6 7,8 |
4,5,6 7 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
- |
4,5,6 7,8,9 |
4,5,6 7,8,9 |
4,5,6 7,8 |
6 7 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Tremor |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
- |
4,5,6 7,8,9 |
4,5,6 7,8,9 |
4,5,6 7,8 |
6 7 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
- |
- |
9 |
8 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sacrificed |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Others |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- No observed signs, I - immediately. * - dyspnoe, ** - vein vasodilatation in hindlimb soles and tail
Table 3.Clinical observation - 50 mg/kg body weight, Animal No 10-15.
Sex |
Dose |
ID |
Administration Result |
Clinical Observation |
♀ |
50 mg/kg |
10 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
11 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
12 |
alive |
lethargy and sleep/sedative behavior ½ an hour after administration and persisted for 1 hour |
||
13 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
14 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
15 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
Table 4.Clinical observation - 50 mg/kg body weight, Animal No 10-15.
Observation |
Time After Administration |
||||||||||||||||||
Hour |
Day |
||||||||||||||||||
I |
0.5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
Skin and Hair** |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Eyes |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Mucosa |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Respiratory System* |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Circulatory System |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
CNS |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Somatomotoric Activity |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Tremor |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Spasms |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Salivation |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Diarrhoea |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Lethargy |
- |
12 |
12 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sleep |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Coma |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Death |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Sacrificed |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Others |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- No observed signs, I - immediately. * - dyspnoe, ** - vein vasodilatation in hindlimb soles and tail
Table 5.Body Weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
191 |
- |
- |
- |
- |
- |
2 |
188 |
- |
- |
- |
- |
- |
||
3 |
193 |
- |
- |
- |
- |
- |
||
♀ |
300 mg/kg |
4 |
160 |
189 |
209 |
29 |
49 |
20 |
5 |
192 |
230 |
250 |
38 |
58 |
20 |
||
6 |
167 |
206 |
223 |
39 |
56 |
17 |
||
7 |
169 |
182 |
203 |
13 |
34 |
21 |
||
8 |
201 |
- |
- |
- |
- |
- |
||
9 |
201 |
- |
- |
- |
- |
- |
||
♀ |
50 mg/kg |
10 |
207 |
227 |
242 |
20 |
35 |
15 |
11 |
196 |
226 |
250 |
30 |
54 |
24 |
||
12 |
197 |
216 |
235 |
19 |
38 |
19 |
||
13 |
210 |
231 |
240 |
21 |
40 |
19 |
||
14 |
221 |
236 |
240 |
15 |
19 |
4 |
||
15 |
201 |
227 |
246 |
26 |
45 |
19 |
Table 6.Necropsy Results
Sex |
Dose |
ID |
Result |
♀ |
2000 mg/kg |
1 |
No obvious pathological changes in gastrointestinal tract were found |
2 |
No obvious pathological changes in gastrointestinal tract were found |
||
3 |
No obvious pathological changes in gastrointestinal tract were found |
||
♀ |
300 mg/kg |
4 |
No findings |
5 |
No findings |
||
6 |
No findings |
||
7 |
No findings |
||
8 |
No obvious pathological changes in gastrointestinal tract were found |
||
9 |
No obvious pathological changes in gastrointestinal tract were found |
||
♀ |
50 mg/kg |
10 |
No findings |
11 |
No findings |
||
12 |
No findings |
||
13 |
No findings |
||
14 |
No findings |
||
15 |
No findings |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 of the test item Lithium difluorobis(oxalate)phosphate is greater than 300 mg/kg and lower than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Lithium difluorobis(oxalate)phosphate is classified in GHS Category 3 with a LD50 cut off value 300 mg/kg body weight, after single oral administration to Wistar rats.
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