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EC number: 436-900-9 | CAS number: 39290-90-9
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 December 2000-01 March 2001
- 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:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (1997)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (2000)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 436-900-9
- EC Name:
- -
- Cas Number:
- 39290-90-9
- Molecular formula:
- Hill Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95) CAS Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95)
- IUPAC Name:
- Magnesium Potassium Titanium Oxide
- Details on test material:
- Batch: 0G99
White powder
Expiry date: 21 August 2001
Specific gravity: 3.38
Test substance storage: At room temperature in the dark
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mammalian cell line, other: Cultured peripheral human lymphocytes
- 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: 1-3-10-33-100 µg/ml (with and without S9-mix)
FIRST AND SECOND CYTOGENETIC ASSAY: 10-33-100 µg/ml (with and without S9-mix) - Vehicle / solvent:
- Dimethyl sulfoxide. TERRACESS P was suspended in dimethyl sulfoxide and treated with ultrasonic waves to obtain a homogeneous suspension. The final concentration of the solvent in the culture medium amounted 1.0 % (v/v).
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Dimethyl sulfoxide
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix
Migrated to IUCLID6: in HBSS without calcium and magnesium: 0.5 µg/ml ( 3 h exposure); 0.2 µg/ml ( 24 h exposure); 0.1 µg/ml ( 48 h exposure)
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9 mix
Migrated to IUCLID6: in HBSS without calcium and magnesium. 15 µg/ml ( 3 h exposure, 24 h fixation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 48h
- Exposure duration: 3h (with and without S9 mix), 24 h or 48 h (without S9 mix)
- Fixation time (start of exposure up to fixation or harvest of cells): 24 h or 48 h
First test: 24h (3h exposure) with and without S9-mix.
Second test: 24h (24h exposure) and 48h (48 h exposure) without S9-mix. 48h (3h exposure) with S9-mix.
SPINDLE INHIBITOR (cytogenetic assays): colchicine
NUMBER OF REPLICATIONS: duplicates in two independent experiments
NUMBER OF CELLS EVALUATED: 100 metaphase chromosome spreads per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index of each culture was determined by counting the number of metaphases per 1000 cells.
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- A test substance was considered positive (clastogenic) in the chromosome aberration test if:
a) it induced a dose-related statistically significant (Chi-square test, P < 0.05) increase in the number of cells with chromosome aberrations.
b) a statistically significant increase in the frequencies of the number of cells with chromosome aberrations was observed in the absence of a clear dose-response relationship.
A test substance was considered negative (not clastogenic) in the chromosome aberration test if none of the tested concentrations induced a statistically significant (Chi-square test, P < 0.05) increase in the number of cells with chromosome aberrations. - Statistics:
- The incidence of aberrant cells (cells with one or more chromosome aberrations, inclusive or exclusive gaps) for each exposure group was compared to that of the solvent control using Chi-square statistics.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes: human peripheral
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Species / strain:
- lymphocytes: human peripheral
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation at 100 ug/l
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at doses of 100 µg/ml
RANGE-FINDING/SCREENING STUDIES: no effects observed - Remarks on result:
- other: other: dose range finding test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Both in the absence and presence of S9-mix TERRACESS P did not induce a statistically or biologically significant increase in the number of cells with chromosome aberrations in two independently repeated experiments.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
TERRACESS P is not clastogenic in human lymphocytes with and without S9 mix tested, in the concentration range 10 up to and including 100 µg/plate.
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