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EC number: 234-796-8 | CAS number: 12033-89-5
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 May to 12 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
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:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Trisilicon tetranitride
- EC Number:
- 234-796-8
- EC Name:
- Trisilicon tetranitride
- Cas Number:
- 12033-89-5
- Molecular formula:
- N4Si3
- IUPAC Name:
- 1Si-hexacyclo[3.1.1.0¹,⁴.0²,⁵.0³,⁶.0³,⁷]trisilazane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch number: A126325
Purity: >98%
Constituent 1
Method
- Target gene:
hemizygous hypoxanthine phoshoribosyl transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test: 10.9, 21.9, 43.8, 87.5, 175, 350, 700 and 1400 μg/mL
Mutation tests:
Test 1: 87.5, 175, 350, 700 and 1400 μg/mL
Test 2: 87.5, 175, 350, 700 and 1400 μg/mL - Vehicle / solvent:
- Sodium chloride (0.9% w/v)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Remarks:
- In the presence of S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- In the absence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 7 days
NUMBER OF REPLICATIONS: Duplicate cultures were used for each test substance concentration and positive control, and four cultures for the vehicle control.
NUMBER OF CELLS EVALUATED: For each culture, three 60 mm tissue culture plates were seeded with 200 cells in H10, to determine cloning efficiency and five 100 mm tissue culture plates with 2E+05 cells in selective medium to determine the number of mutant colonies.
DETERMINATION OF CYTOTOXICITY
- Method: Colonies were counted and the Day 1 relative survival was calculated.
No additional data - Evaluation criteria:
- The statistical significance of the data was analysed by weighted analysis of variance, weighting assuming a Poisson distribution following the methods described by Arlett et al. (1989). Tests were conducted for a linear concentration-response relationship of the test substance, for non-linearity and for the comparison of positive control to vehicle control. The criteria for a positive response will be:
The demonstration of a statistically significant increase in mutant frequency following exposure to the test substance;
Evidence of a relationship, over at least two dose levels, in any increase in mutant frequency;
Demonstration of reproducibility in any increase in mutant frequency;
The mean mutant frequency should fall outside the upper limit of the historical vehicle control of 20 mutants per 1E+06 survivors with a corresponding survival rate of 20% or greater. - Statistics:
- None stated
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary toxicity test:
In the preliminary toxicity test, a four-hour exposure to 1400 μg/mL the test substance, in the absence or the presence of S9 mix, resulted in Day 1 Relative Survivals of 101 to 78% and 130 to 80 % respectively. Concentrations for the main test were based upon these data.
Main mutation test 1 - 4 hour treatment in the absence of S9 mix:
Cultures were exposed to the test substance at concentrations from 87.5 to 1400 μg/mL. Precipitate was seen at 700 μg/mL and above post dosing and at 175 μg/mL and above at the end of treatment. Exposure to the test substance resulted in Day 1 Relative Survivals of between 101 and 21%. All cultures exposed were plated out for determination of Cloning Efficiency and mutation induction. The Day 8 Cloning Efficiencies were not reduced relative to the vehicle controls. No significant increases in Mutant Frequency were observed after exposure to the test substance. EMS, the positive control substance, induced significant increases in Mutant Frequency.
Main mutation test 1 - 4 hour treatment in the presence of S9 mix:
Cultures were exposed to the test substance at concentrations from 87.5 to 1400 μg/mL. Precipitate was seen at 700 μg/mL and above post dosing and at 175 μg/mL and above at the end of treatment. Exposure to the test substance resulted in Day 1 Relative Survivals of between 102 and 43 %. All cultures exposed were plated out for determination of Cloning Efficiency and mutation induction. The Day 8 Cloning Efficiencies were reduced from 106 to 49% relative to the vehicle control. No significant increases in Mutant Frequency were observed after exposure to the test substance. 3MC, the positive control substance, induced significant increases in Mutant Frequency.
Main mutation test 2 - 4 hour treatment in the absence of S9 mix:
Cultures were exposed to the test substance at concentrations from 87.5 to 1400 μg/mL. Precipitate was seen at 700 μg/mL and above post dosing and at 175 μg/mL and above at the end of treatment. Exposure to the test substance resulted in Day 1 Relative Survivals of between 94 and 17%. All cultures exposed were plated out for determination of Cloning Efficiency and mutation induction. The Day 8 Cloning Efficiencies were 102 to 74% relative to the vehicle control. No significant increases in Mutant Frequency were observed after exposure to the test substance. EMS, the positive control substance, induced significant increases in Mutant Frequency.
Main mutation test 2 - 4 hour treatment in the presence of S9 mix:
Cultures were exposed to the test substance at concentrations from 87.5 to 1400 μg/mL. Precipitate was seen at 700 μg/mL and above post dosing and at 175 μg/mL and above at the end of treatment. Exposure to the test substance resulted in Day 1 Relative Survivals of between 103 and 44%. All cultures exposed were plated out for determination of Cloning Efficiency and mutation induction. The Day 8 Cloning Efficiencies were 99 to 85% relative to the vehicle control. No significant increases in Mutant Frequency were observed after exposure to the test substance. 3MC, the positive control substance, induced significant increases in Mutant Frequency. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that the test substance did not demonstrate mutagenic potential in this in vitro HPRT cell mutation assay, under the experimental conditions described.
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