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EC number: 445-620-6 | CAS number: 39318-30-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June-08 July 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study has been performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2000)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Lithium Potassium Titanium Oxide
- EC Number:
- 445-620-6
- Cas Number:
- 39318-30-4
- Molecular formula:
- Hill Empirical formula: K(0.5-0.7) Li(0.27) Ti(1.73) O(3.8-3.95) CAS Empirical formula: K(0.5-0.7) Li(0.27) Ti(1.73) O(3.8-3.95)
- IUPAC Name:
- Lithium Potassium Titanium Oxide
- Details on test material:
- Batch: 2D82A
White powder, crystal structure
Expiry date: 31 May 2003
Test substance storage: At room temperature in the dark
Constituent 1
Method
- Target gene:
- An histidine-requiring gene in S. typhimurium and a tryptophan-requiring gene in E.coli.
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 liver homogenate of rat treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Dose range finding on TA100 and WP2uvrA: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate (with and without 5% metabolic activation).
Mutation assay: first experiment on TA1535, TA1537 and TA98; second experiment on TA1535, TA1537, TA98, TA100 and WP2uvrA.
Concentration range: 10- 33-100-333-1000 µg/plate (with and without metabolic activation: 5% in experiment 1; 10% in experiment 2). - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO). The test substance was suspended in dimethyl sulfoxide. Treated with ultrasonic waves.
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix: 5 µg/plate in Saline for TA1535
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix: 60 µg/plate in Saline for TA1537
- Positive controls:
- yes
- Positive control substance:
- other: daunomycine 4 µg/plate in Saline for TA98
- Remarks:
- without S9 mix
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9 mix: 650 µg/plate in DMSO for TA100
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix: 10 µg/plate in DMSO for WP2 uvr A
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide
- Positive controls:
- other: 2-aminoanthracene (1, 2.5 or 5 µg/plate in DMSO) for all tester strains
- Remarks:
- with S9 mix
- Untreated negative controls:
- yes
- Remarks:
- dimethyl sulfoxide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
In agar (plate incorporation)
Top agar in top agar tubes was molten and heated to 45°C. The following solutions were successively added to 3 mL molten top agar: 0.1 mL of a fresh bacterial culture (10E9 cells/mL) of one of the tester strains, 0.1 mL of a dilution of the test substance in dimethyl sulfoxide and either 0.5 mL S9-mix (in case of activation assays) or 0.5 mL 0.1 M phosphate buffer (in case of non-activation assays). The ingredients were mixed on a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were turned and incubated in the dark at 37 ± 1 °C for 48 h. After this period revertant colonies (histidine independent for Salmonella typhimurium bacteria and tryptophan independent for Escherichia coli) were counted.
The revertant colonies were counted automatically or manually, if less than 40 colonies per plate were present. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually.
NUMBER OF REPLICATIONS:
Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
In the first and second experiment 5% (v/v) and 10% (v/v) S9-mix was used, respectively.
DETERMINATION OF CYTOTOXICITY:
Method: the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
Precipitation of the test substance. - 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 of the 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:
- A Salmonella typhimurium reverse mutation assay and/or Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
a) The negative control data (number of spontaneous revertants per plate) should be within the laboratory background historical range for each tester strain.
Strain Minimum value Maximum value Mean ± 3 x S.D
TA1535 -S9-mix 3 25 12 ± 12
+S9-mix 3 25 13 ± 12
TA1537 -S9-mix 3 26 6 ± 9
+S9-mix 3 28 7 ± 10
TA98 - S9-mix 12 45 18 ± 17
+S9-mix 12 54 24 ± 22
TA100 -S9-mix 56 180 96 ± 80
+S9-mix 59 184 94 ± 73
WP2uvrA -S9-mix 4 30 12 ± 14
+S9-mix 4 30 12 ± 14
b) The positive control chemicals should produce responses in all tester strains which are within the laboratory historical range documented for each positive control substance.
Strain Minimum value Maximum value Mean ± 3 x S.D
TA1535 -S9-mix 91 993 284 ± 575
+S9-mix 60 1028 222 ± 302
TA1537 -S9-mix 77 1897 348 ± 539
+S9-mix 73 1794 339 ± 583
TA98 -S9-mix 100 1855 592 ± 931
+S9-mix 169 2597 783 ± 1126
TA100 -S9-mix 279 2070 810 ± 779
+S9-mix 190 2753 908 ± 1260
WP2uvrA -S9-mix 70 1827 561 ± 887
+S9-mix 62 933 233 ± 434
c) The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
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, but tested up to precipitating concentrations
- Remarks:
- at 1000 ug/plate
- 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, but tested up to precipitating concentrations
- Remarks:
- at 1000 ug/plate
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATION:
Precipitation of TERRACESS L on the plates was observed at the end of the incubation period at concentrations of 1000 µg/plate.
TOXICITY:
No reduction of the bacterial background lawn and no biologically significant decrease in the number of revertants were observed.
Any other information on results incl. tables
The negative and strain-specific positive control values were within the laboratory background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
TERRACESS L is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay with and without S9 mix tested, in the concentration range 10 up to and including 1000 µg/plate.
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