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EC number: 231-439-8 | CAS number: 7550-35-8
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999-11-25 to 2000-01-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study. Read-across was performed with lithium hydroxide. Please refer to IUCLID section 13 for read-across justification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Lithium hydroxide
- EC Number:
- 215-183-4
- EC Name:
- Lithium hydroxide
- Cas Number:
- 1310-65-2
- Molecular formula:
- LiOH
- IUPAC Name:
- Lithium hydroxide
- Test material form:
- other: solid
Constituent 1
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- -> his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA 1535, TA 100) and frameshift (TA 1537, TA 98) mutations. The Escherichia coli WP2 uvrA (trp) reversion system measures trp– -> trp+ reversions. The Escherichia coli WP2 uvrA detect mutagens that cause other base-pair substitutions (AT to GC).
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Lithium hydroxide was tested in concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate with and without S9 mix.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 without S9
Migrated to IUCLID6: NaN3
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without S9
Migrated to IUCLID6: 9AA
- Positive control substance:
- other: daunomycine (DA)
- Remarks:
- TA 98 without S9
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- TA 100 without S9
Migrated to IUCLID6: MMS
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- WP2uvrA without S9
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- TA 1537, TA 1535, TA 98, TA 100, E. coli WP2uvrA with S9
- Details on test system and experimental conditions:
- The test substance was dissolved in Milli-Q-water. The test substance was ground and the stock solution was filter(0.22 µm)-sterilized. Test substance concentrations were prepared directly prior to use.
Range finding study:
Lithium hydroxide was tested in the tester strains TA 100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the absence and in the presence of S9 mix.
Mutation assay:
Based on the results of the dose range finding study, lithium hydroxide was tested up to concentrations of 5000 µg/plate in the absence and in the presence of S9-mix in two mutation experiments. The first mutation experiment was performed with the strains TA 1535, TA 1537 and TA 98; the second mutation experiment was performed with the strains TA 1535, TA 1537, TA 98, TA 100 and WP2uvrA. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any tester strains, either with or without metabolic activation.
However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment. - Statistics:
- Not indicated
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- GENOTOXICITY:
Please refer to tables 1 and 2, which are presented under Sect. "Remarks on results including tables and figures"
- without metabolic activation: No increase in the number of revertants/plate observed
- with metabolic activation: No increase in the number of revertants/plate observed
CYTOTOXICITY:
No reduction of the bacterial background lawn was observed in all dose levels tested. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment 1
Mutagenic response of lithium hydroxide in the Salmonella typhimurium reverse mutation assay and the Escherichia coli reverse mutation assay:
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (±SD) with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
Without S9-mix |
|||||
positive control |
219±33 |
435±100 |
371±39 |
466±22 |
172±32 |
solvent control |
12±6 |
7±3 |
16±3 |
65±2 |
9±2 |
|
|||||
3 |
|
|
|
77±13 |
12±3 |
10 |
|
|
|
72±7 |
11±3 |
33 |
|
|
|
79±8 |
8±2 |
100 |
12±1 |
7±5 |
18±3 |
74±8 |
12±3 |
333 |
15±1 |
7±1 |
16±4 |
65±7 |
7±3 |
1000 |
14±3 |
4±2 |
19±3 |
80±8 |
9±2 |
3330 |
11±3 |
8±3 |
12±4 |
77±13 |
5±2 |
5000 |
12±1 |
6±2 |
12±5 |
77±11 |
4±1 |
With S9-mix[1] |
|||||
positive control |
296±23 |
703±22 |
1346±230 |
1199±176 |
237±37 |
solvent control |
14±6 |
6±2 |
26±3 |
90±10 |
11±3 |
|
|||||
3 |
|
|
|
96±4 |
12±3 |
10 |
|
|
|
99±5 |
12±4 |
33 |
|
|
|
95±9 |
9±3 |
100 |
11±3 |
6±3 |
31±4 |
78±11 |
12±2 |
333 |
15±1 |
4±1 |
27±9 |
101±5 |
10±1 |
1000 |
18±7 |
9±1 |
26±6 |
83±12 |
11±3 |
3330 |
15±6 |
5±1 |
25±3 |
86±14 |
7±4 |
5000 |
14±2 |
4±1 |
22±3 |
65±1 |
4±1 |
Solvent control: 0.1 ml Milli-Q water
[1]The S9-mix contained 5% (v/v) S9 fraction
Experiment 2
Mutagenic response of lithium hydroxide in the Salmonella typhimurium reverse mutation assay and in the escherichia coli reverse mutation assay:
Dose (μg/plate) |
Mean number of revertant colonies/3 replicate plates (±S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
Without S9-mix |
|||||
positive control |
195±2 |
287±105 |
642±125 |
608±24 |
696±16 |
solvent control |
10±1 |
4±2 |
15±4 |
69±10 |
8±1 |
|
|||||
100 |
12±4 |
4±2 |
13±2 |
79±13 |
10±1 |
333 |
8±3 |
4±3 |
16±7 |
68±10 |
8±3 |
1000 |
12±5 |
5±2 |
15±2 |
70±7 |
11±2 |
3330 |
11±4 |
4±2 |
10±4 |
60±11 |
6±1 |
5000 |
7±1 |
5±2 |
11±3 |
64±8 |
7±3 |
With S9-mix[1] |
|||||
positive control |
203±14 |
367±45 |
551±25 |
709±131 |
70±8 |
solvent control |
9±1 |
3±2 |
23±3 |
67±6 |
11±5 |
|
|||||
100 |
10±4 |
3±1 |
23±3 |
84±14 |
12±3 |
333 |
8±2 |
3±3 |
25±4 |
70±8 |
12±2 |
1000 |
9±4 |
6±3 |
22±6 |
68±11 |
7±2 |
3330 |
11±5 |
3±2 |
14±4 |
49±6 |
7±2 |
5000 |
5±3 |
3±2 |
13±2 |
54±8 |
3±1 |
Solvent control: 0.1 ml Milli-Q water
[1]The S9-mix contained 5% (v/v) S9 fraction
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Based on the results of this study it is concluded that lithium hydroxide is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
A bacteria reverse mutation test with lithium bromide was not available. Consequently, read-across was applied using study results obtained from lithium hydroxide as it is a characteristically similar compound.
Lithium hydroxide was tested in the Salmonella typhimurium reverse mutation assay according to OECD Guideline 471. The test was performed with four histidine-requiring strains of Salmonella typhimurium (TA 1535, TA 1537, TA 100 and TA 98) and in the Escherichia coli reverse mutation assay with a tryptophane-requiring strain of Escherichia coli WP2uvrA in two independent experiments. Lithium hydroxide was tested up to concentrations of 5000 µg/plate in the absence and presence of S9 -mix. Lithium hydroxide did not precipitate on the plates at this dose level. The bacterial background lawn was not reduced at all concentrations tested. Reduction in the number of revertants was observed in the tester strain TA 1535, TA 98, TA 100 and WP2uvrA. Lithium hydroxide did not induce a dose-related, two-fold, increase in the number of revertant (His+) colonies in each of the four tester strains (TA 1535, TA 1537, TA 98 and TA 100) and in the number of revertant (Trp+) colonies in the tester strain WP2uvrA both in the absence and presence of S9 -metabolic activation. These results were confirmed in an independently repeated experiment.
Based on the results of this study it is concluded that lithium hydroxide, respective lithium bromide is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. (NOTOX, 2000)
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