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EC number: 255-280-9 | CAS number: 41253-21-8
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Dec. 2, 2005 to Jul. 27, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD 473)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1H-1,2,4-triazole, sodium salt
- EC Number:
- 255-280-9
- EC Name:
- 1H-1,2,4-triazole, sodium salt
- Cas Number:
- 41253-21-8
- Molecular formula:
- C2H3N3.Na
- IUPAC Name:
- sodium 1,2,4-triazol-1-ide
- Details on test material:
- - Lot/batch No.: 05.14
- Expiration date of the lot/batch: September 2006
- Storage condition of test material: At room temperature and protected humidity.
- Physical state: White powder
- Analytical purity: 99.2% (w/w)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human lymphocytes
- Details on mammalian cell type (if applicable):
- - Periodically checked for karyotype stability: yes
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver microsomes
- Test concentrations with justification for top dose:
- 1st experiment - S9 (3 hours): 0, 78.13, 156.3, 312.5, 625, 937.5, 1250, 2500, and 5000 µg/mL
2nd experiment -S9 (20 hours): 0, 312.5, 625, 937.5, 1250, 1875, and 2000 µg/mL
2nd experiment - S9 (44 hours): 0, 312.5, 625, 937.5, 1250, 1875, and 2000 µg/mL
1st experiment + S9 (3 hours): 0, 78.13, 156.3, 312.5, 625, 937.5, 1250, 2500, and 5000 µg/mL
2nd experiment + S9 (3 hours): 0, 312.5, 625, 937.5, 1250, 1875, and 2000 µg/mL
2nd experiment + S9 (3 hours): 0, 312.5, 625, 937.5, 1250, 1875, and 2000 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for injections
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water for injections
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: with S9 mix
- Details on test system and experimental conditions:
- 1st experiment: Lymphocyte cultures were exposed to test article or control for 3 hours both in the absence or presence of S9.
Harvest time was 20 hours after the beginning of treatment.
2nd experiement: Without S9, cells were exposed continuously to the test or control item until harvest. With S9, cells were exposed to the test or control item for 3 hours then rinsed. Harvest time were 20 hours and 44 hours after the beginning of testing.
NUMBER OF REPLICATIONS: 2 independent experiments.
NUMBER OF CELLS EVALUATED: 200 metaphases/dose level.
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes
- Determination of endoreplication: Yes - Evaluation criteria:
- The cytotoxicity of the test item was evaluated using the mitotic index. Analysis of 200 metaphases/dose level was made. The following structural aberrations were recorded for each metaphase: gaps, chromatid and chromosome breaks and exchanges, multiple aberrations and pulverizations.
- Statistics:
- Chi-square test.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- decrease of mitotic index
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- -Experiments without S9 :
Cytotoxicity : Following the 3-hour treatment, a slight to strong toxicity was induced at dose-levels > or = 2500 µg/ml, as shown by 33-100% decrease in mitotic index. Following the 20-hour treatment, a slight to moderate toxicity was induced at dose-levels > or = 1875 µg/ml, as shown by 23-45% decrease in mitotic index. Following the 44-hour treatment, no decrease in mitotic index was noted.
Metaphase analysis : The dose-levels selected for metaphase analysis were : 312.3 , 625 and 1250 µg/ml for the 3-hour and 20-hour treatments, higher dose-levels inducing a significant increase in pH value; 1250 µg/ml for the 44-hour treatment, higher dose-levels inducing a significant increase in pH value. No significant increase in the frequency of cells with structural chromosomal aberrations was noted after 3-, 20- as well as 44-hour treatments.
-Experiment with S9 :
Cytotoxicity : At the 20-hour harvest time, a slight to strong toxicity was induced at dose-levels > 2000 µg/ml, as shown by 32-100% decrease in mitotic index. At the 44-hour harvest time, no decrease in mitotic index.
Metaphase analysis : the dose-levels selected for metaphase analysis were 312.5 , 625 and 1250 µg/ml for the 20-hour harvest time in both experiments, higher dose-levels inducing a significant increase in pH value; 1250 µg/ml for the 44-hour harvest time higher dose-levels inducing a significant increase in pH value.
No significant increase in the frequency of cels with structural chromosomal aberrations was noted in either experiment and at either harvest time.
The frequency of cells with structural chromosome aberrations of the vehicle and positive controls was as specified in acceptance criteria. the study was therefore considered valid. - Remarks on result:
- other: strain/cell type: human lymphocytes
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test item was freely soluble in the vehicle (water for injections) at 100 mg/mL.
No precipitate was noted at the end of the treatement period, at any tested dose.
Due to the increase in pH observed in the treated dose-levels, pH measurements were peformed int reated medium at a time equivalent to the end of the treatment period. At 5000 µg/mL (the highest dose), the pH was approximately 9.7 (7.6 for the vehicle control) and the osmolarity equal to 390 mOsm/kg H2O (292 for the vehicle control).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
1,2,4-triazole did not induce chromosome aberrations in cultured human lymphocytes.The frequency of cells with structural chromosome aberrations of the vehicle and positive controls was as specified in acceptance criteria. the study was therefore considered valid. - Executive summary:
The study was performed according to the international guidelines (OECD 473) and in compliance with the principles of GLP regulations. 1,2,4 -triazole sodium salt was tested in two independent experiments, both with and without a liver metabolizing system (S9 mix), obtained from rats previously treated with Aroclor 1254.
The highest dose-level for treatment in the first experiment was selected in the basis of pH, osmolarity and solubility. For selection of the dose-levels for the second experiment, any toxicity indicated by the reduction of mitotic index in the first experiment was also taken into account. In the first experiment, lymphocyte cultures were exposed to the test or control item (with or without S9 mix) for 3 hours then rinsed. Cekks were harvested 20 hours after the beginning of treatment. The second experiment was performed as follow : without S9 mix, cells were exposed continuously to the test or control item until harvest ; and with S9 mix, cells were exposed to the test or control item for 3 hours and then rinsed.Cells were harvested 20 hours and 44 hours after treatment.
One and a half hours before harvest, each cuture was treated with a colcemid solution to block cells at the metaphase-stage of mitosis. 1,2,4 -triazole sodium salt was dissolved in water for injections. Positive controls were used.
No significant increase in the frequency of cells with structural chromosomal aberrations was noted in either experiment and at either harvest time, without and with S9 mix. The frequency of cells with structural chromosome aberrations of the vehicle and positive controls was as specified in acceptance criteria. the study was therefore considered valid.
1,2,4-triazole sodium salt did not induce chromosome aberrations in cultured human lymphocytes.
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