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EC number: 279-505-5 | CAS number: 80584-91-4
- 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
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- Auto flammability
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Dissociation constant
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- 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
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: genome mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-06-01 to 2012-12-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 487
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
- EC Number:
- 279-505-5
- EC Name:
- 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
- Cas Number:
- 80584-91-4
- Molecular formula:
- C21H36N6O6
- IUPAC Name:
- 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): TC, dried
- Physical state: White powder
- Analytical purity: 95.57%
- Moisture: 0.05%
- Melting point: 181-185 °C
- Lot/batch No.: 110525S
- Expiration date of the lot/batch: 25-05-2016
- Storage condition of test material: ambient temperature (15-25°C)
- Other: soluble in DMSO
Constituent 1
Method
- Target gene:
- Formation of micronuclei in human peripheral blood lymphocytes
Species / strain
- Species / strain / cell type:
- lymphocytes:
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian liver post-mitochondrial fraction (S9), prepared from Sprague Dawley male rats
- Test concentrations with justification for top dose:
- Range-finding: 0, 9.375, 18.75, 37.5, 75, 150, 300 µg/mL (final concentrations)
Definitive test. experiment 1, -S9: 75, 150, 300 µg/mL + vehicle (1% DMSO v/v ) + Cytosine arabinoside (pos. control)
Definitive test. experiment 1, +S9: 75, 150, 300 µg/mL + vehicle (1% DMSO v/v ) + Cytosine arabinoside (pos. control)
Definitive test. experiment 2, -S9: 7.5, 15, 30, 60, 120, 240, 480 µg/mL + vehicle (1% DMSO v/v ) + DMBA (pos. control)
Definitive test. experiment 2, +S9: 7.5, 15, 30, 60, 120, 240, 480 µg/mL + vehicle (1% DMSO v/v ) + DMBA (pos. control)
Appropriate amount of test item was weighted and diluted in DMSO not earlier than 30 min prior to test start. For dilution of final doses, sterile DMSO was used. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO+ culture medium
Controls
- Untreated negative controls:
- yes
- Remarks:
- culture medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Cytosine arabinoside was used as positive control without S9mix, Cyclophosphamide monohydrate was used as positive control with S9mix.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
10exp5 cells in 75 µl
DURATION
- Exposure duration: 20 hr
METHOD OF APPLICATION: in medium;
DURATION
- Preincubation period: 24 hours
- Exposure duration: 20 hours
- Time with Cytochalasin B: 28 hours:
- Fixation time (start of exposure up to fixation or harvest of cells): 72 hours
SPINDLE INHIBITOR (cytogenetic assays): Cytochalasin B
STAIN (for cytogenetic assays): 2% Giemsa-Romanowski for 10 minutes
NUMBER OF CELLS EVALUATED: 10exp5 cells
DETERMINATION OF CYTOTOXICITY
- Method: other: replication index (Number of binucleated cells, mulinucleated cells and toatal number) - Evaluation criteria:
- For the untreated controls and solvent controls, the measured average number of micronuclei is related to the spontanous occurence of micronuclei. A two tailed Student's t-test revealed if the test substance can be considered as positive, negative or equivocal.
- Statistics:
- Student's t-test
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- 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
Any other information on results incl. tables
Experiment 1: range-finding test without metabolic activation
Experiment 2:definitive test with and without metabolic activation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
TC, dried did not induce micronuclei neither with nor without metabolic activation by S-9 mix in human lymphocytes. TC, dried was considered to be non-mutagenic. - Executive summary:
TC, dried was dissolved in DMSO in concentrations of 9.375 to 300 µg/ml in an in vitro micronucleus test with human lymphocytes according to OECD 487.
Up to and including the highest possible concentrations TC, dried, did not induce micronuclei neither with nor without metabolic activation by S-9 mix.
Therefore TC, dried was considered to be non-mutagenic.
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