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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-820-4 | CAS number: 10377-48-7
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-04-30 to 2010-07-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2006
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- In order to confirm correct dosage and stability of exposure concentrations samples (about 50 mL) of the control and all test concentrations were taken from separate vessels including culture medium (controls), test solutions and algae at 0 h and 72 h. In order to remove the algae from the test solutions, AES-analysis was performed after centrifugation of the samples at 3950 rpm for 10 minutes, followed by dilution of the samples in deionised water to meet the linear range of the calibration lines.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test solutions were prepared in a dilution series from a stock solution of 100 mg/L of the test Item in culture medium for the range-finding test and from a stock solution of 400 mg/L of the test item in culture medium for the definitive test, respectively. The stock solutions and the corresponding dilutions were prepared using a mixing device (Ultra-Turrax, Janke & Kunkel; 8000 rpm, 2 minutes). The test solutions were clear at all test concentrations. The range-finding test and the definitive test were performed as static tests, i.e., without renewal of the test solutions. The controls were kept in culture-medium. Vessels including culture-medium (controls) and test solutions were kept under the same conditions as the test vessels for concentration analysis. Concentration-analysis was performed at 0 h and 72 h. The Alga-test was carried without adjustment of the pH. - Test organisms (species):
- Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)
- Details on test organisms:
- TEST ORGANISM
- Common name: Desmodesmus subspicatus (Chlorophyceae, Chlorococcales),
- Strain: SAG 86.81
- Source (laboratory, culture collection): Albrecht von Haller Institut für Pflanzenwissenschaften der Universität Göttingen
- Method of cultivation: Sterile on agar tubes (0.8 % Agar). Transferred to a new agar tube every 2 months. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 24.2 to 24.7 °C
- pH:
- in the flasks at 0 h:
8.0 to 10.9
in the flasks at 72 h:
9.6 to 10.6
The test item had a significant effect on the pH of the test solutions at the start of the exposure period. - Nominal and measured concentrations:
- Nominal test concentrations: Control, 25.0 mg/L, 50.0 mg/L, 100 mg/L, 200 mg/L, 400 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks (test volume 100 mL)
- Aeration: none
- Initial cells concentration: 5000 cells/mL
- No. of vessels per test group (replicates): 3
- No. of vessels per control group (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes - Reference substance (positive control):
- no
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 400 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 90 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- The test item had a significant effect on the pH of the test solutions at the start of the exposure period. The increase of pH in the control and test concentration of 25.0 mg/L during the exposure period is caused by the growth of the algae in the test vessels. In common with other species of fresh-water algae, Desmodesmus subspicatus gains CO2 from HCO3-, leading to a release of hydroxide ions, that raise the pH of the medium. After 72 hours, the pH at test concentration of 100 mg/L had remained stable, a slight decrease of the pH was observed at test concentrations of 50, 200 and
400 mg/L when compared to the 0 hour measurements. In the test the increase of pH in the control of 2.6 (> 1.5 units as recommended in OECD Guideline 201) had no effect on the growth of the algae as the validity criteria for algal growth were fulfilled. - Reported statistics and error estimates:
- The Kolmogorov-Smirnov-test determined normality of the data (α = 0.05). The results of a one-way ANOVA showed a significant effect on the specific growth rate [u] in the presence of Lithium carbonate (F = 66.04; F critical = 5, 12, α = 0.05 = 3.11). Bartlett`s test detected homogeneity of variances (α = 0.05). Dunnett`s test for comparison of the treatment groups with the control showed significant differences between the control and the effective concentrations of 100, 200 and 400 mg/L (α = 0.05).
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this 72-h algal growth inhibition test with Desmodesmus subspicatus the 72-h EC50 of lithium carbonate based on growth rate was determined as greater than 400 mg/L. The overall NOEC was determined to be 50 mg/L. The results are based on the nominal concentrations.
- Executive summary:
The effect of lithium carbonate on the growth of an algal species Desmodesmus subspicatus over a 72-hour static exposure period was assessed according to OECD guideline 201. The test solutions were prepared in a dilution series from a stock solution of 100 mg/L of the test item in culture medium for the range-finding test and from a stock solution of 400 mg/L of the test item in culture medium for the definitive test, respectively. The stock solutions and the corresponding dilutions were prepared using a mixing device (Ultra-Turrax, Janke & Kunkel; 8000 rpm, 2 minutes). The test solutions were clear at all test concentrations. The controls were kept in culture medium. Vessels including culture medium (controls) and test solutions were kept under the same conditions as the test vessels for concentration analysis. Concentration analysis was performed at 0 h and 72 h. The Alga-test was carried without adjustment of the pH.AES-analysis confirmed that the test solutions were correctly dosed, i.e., the recoveries were within 92.4 to 103 % of the nominal concentrations at study start. At the end of the exposure, i.e., after 72 hours, the recoveries ranged from 95.9 to 103 % of the nominal concentrations demonstrating that the lithium concentrations were stable throughout the exposure period. Consequently, the results of the definitive test were based on nominal concentrations.In this 72-h algal growth inhibition test with Desmodesmus subspicatus the 72-h EC50 based on growth rate was determined as greater than 400 mg/L for lithium carbonate.
The overall NOEC was determined to be 50 mg/L for lithium carbonate (the calculated NOEC for lithium ion: 9.39 mg/L) . The results are based on the nominal concentrations.
Reference
Concentration of the test item, cells/mL in the test flasks at 72 h, average specific growth rate [µ]over the whole testing period 0-72 h, mean value of the average specific growth rate [µ], standard deviation and coefficient of variation Vc[%], inhibition [%] and mean value of inhibition [%] of the average specific growth rate [µ] in the definitive test:
Concentration [mg/L] |
Cells / mL |
Average Specific growth rate [µ] |
Average Specific growth rate [µ] Mean value |
Standard deviation |
Coefficient of variation Vc [%] |
Inhibition of Average Specific growth rate [%] |
Inhibition of Average Specific growth rate Mean value [%] |
|
72 h |
0-72 h |
0-72 h |
0-72 h |
0-72 h |
0-72 h |
0-72 h |
Control 1 |
720000 |
1.66 |
1.66
|
0.01
|
0.90
|
|
|
Control 2 |
752000 |
1.67 |
|||||
Control 3 |
688000 |
1.64 |
|||||
25.0 |
752000 |
1.67 |
1.68
|
0.01
|
0.82
|
-0.89 |
-1.37 *
|
25.0 |
808000 |
1.70 |
-2.33 |
||||
25.0 |
752000 |
1.67 |
-0.89 |
||||
50.0 |
512000 |
1.54 |
1.57
|
0.08
|
5.02
|
6.85 |
5.15
|
50.0 |
728000 |
1.66 |
-0.24 |
||||
50.0 |
464000 |
1.51 |
8.83 |
||||
100 |
312000 |
1.38 |
1.44
|
0.06
|
3.93
|
16.8 |
13.0 **
|
100 |
432000 |
1.49 |
10.3 |
||||
100 |
400000 |
1.46 |
11.8 |
||||
200 |
320000 |
1.39 |
1.33
|
0.06
|
4.49
|
16.3 |
20.0 **
|
200 |
224000 |
1.27 |
23.5 |
||||
200 |
264000 |
1.32 |
20.2 |
||||
400 |
136000 |
1.10 |
1.09
|
0.02
|
2.22
|
33.5 |
34.4 **
|
400 |
136000 |
1.10 |
33.5 |
||||
400 |
120000 |
1.06 |
36.0 |
* Remark: A negative inhibition value means an enhancement of the parameter.
** Significant difference compared to the control according to Dunnett`s test (p = 0.05).
Description of key information
In this 72-h algal growth inhibition test with Desmodesmus subspicatus the 72-h EC50 of lithium carbonate based on growth rate was determined as greater than 400 mg/L. The overall NOEC was determined to be 50 mg/L. The results are based on the nominal concentrations. Based on read-across approach, the 72-hour EC10, EC50 and overall NOEC of lithium sulfate anhydrous are 134, greater than 596 and 75 mg/L, respectively. For the read-across approach of lithium sulfate monohydrate the values of 72-hour EC10, EC50 and overall NOEC are 156, greater than 692 and 87 mg/L, respectively.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 596 mg/L
- EC10 or NOEC for freshwater algae:
- 134 mg/L
Additional information
key study
A toxicity study in aquatic algae with lithium sulfate or its monohydrate was not available. Consequently, read-across was applied using study results obtained from a supporting substance, lithium carbonate.
The effect of lithium carbonate on the growth of an algal species Desmodesmus subspicatus over a 72-hour static exposure period was assessed according to OECD guideline 201. The test solutions were prepared in a dilution series from a stock solution of 100 mg/L of the test item in culture medium for the range-finding test and from a stock solution of 400 mg/L of the test item in culture medium for the definitive test, respectively. The stock solutions and the corresponding dilutions were prepared using a mixing device (Ultra-Turrax, Janke & Kunkel; 8000 rpm, 2 minutes). The test solutions were clear at all test concentrations. The controls were kept in culture medium. Vessels including culture medium (controls) and test solutions were kept under the same conditions as the test vessels for concentration analysis. Concentration analysis was performed at 0 h and 72 h. The Alga-test was carried without adjustment of the pH.AES-analysis confirmed that the test solutions were correctly dosed, i.e., the recoveries were within 92.4 to 103 % of the nominal concentrations at study start. At the end of the exposure, i.e., after 72 hours, the recoveries ranged from 95.9 to 103 % of the nominal concentrations demonstrating that the lithium concentrations were stable throughout the exposure period. Consequently, the results of the definitive test were based on nominal concentrations.In this 72-h algal growth inhibition test with Desmodesmus subspicatus the 72-h EC50 based on growth rate was determined as greater than 400 mg/L for lithium carbonate.
The overall NOEC was determined to be 50 mg/L for lithium carbonate (the calculated NOEC for lithium ion: 9.39 mg/L) . The results are based on the nominal concentrations. (Steinbeis, 2010)
Based on read-across approach, the 72-hour EC10, EC50 and overall NOEC of lithium sulfate anhydrous are 134, greater than 596 and 75 mg/L, respectively. For the read-across approach of lithium sulfate monohydrate the values of 72-hour EC10, EC50 and overall NOEC are 156, greater than 692 and 87 mg/L, respectively.
supporting data
As laid down in Council Directive 98/83/EC a limit concentration of 250 mg/L sulfate (equivalent to 286 mg Li2SO4/L and 333 mg Li2SO4*H2O/L) in drinking water was agreed.
When comparing the results of read-across
from sulfate and lithium carbonate, the magnitude of the limit
concentration for drinking water and the calculated NOEC value show that
lithium is the relevant toxicological moiety of lithium sulfate.
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.