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EC number: 213-983-8 | CAS number: 1070-89-9
- 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Experimental Toxicology and Ecology BASF SE, 67055 Ludwigshafen, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-sodiohexamethyldisilazane
- EC Number:
- 213-983-8
- EC Name:
- N-sodiohexamethyldisilazane
- Cas Number:
- 1070-89-9
- Molecular formula:
- C6H19NSi2.Na
- IUPAC Name:
- sodiobis(trimethylsilyl)amine
- Details on test material:
- - Name of test material (as cited in study report): Na-Hexamethyldisilazane
- Physical state: Solid, beige
- Analytical purity: 98.5%
- Stability: The stability of the test item under storage conditions throughout the study period was guaranteed.
- Storage condition of test material: Room temperature (N2 conditions, protected from humidity)
Constituent 1
Method
- Target gene:
- - S. typhimurium: His-locus
- Escherichia coli: Trp-locus
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 fraction of phenobarbital/β-naphthoflavone - induced rats
- Test concentrations with justification for top dose:
- - 1st experiment: Standard plate test: 0, 20, 102, 510, 2550, 5100 µg/plate
- 2nd experiment: Preincubation test: 0, 318.8, 637.5, 1275, 2550, 5100 µg/plate
- 3rd experiment: Preincubation test: 0, 4, 20, 100, 500, 1000 µg/plate (TA 1535, TA 1537and TA 98 with and without S9 mix;
TA 100 and E. coli without S9 mix) and 0, 8, 40, 200, 1000, 2000 µg/plate (TA 100 and E. coli with S9 mix)
- 4rd experiment: Preincubation test: 0, 31.3, 62.5, 125, 250, 500, 750, 1000 µg/plate (TA 100 and TA 1537 without S9 mix) and 0, 62.5, 125, 250, 500, 1000, 1500, 2000 µg/plate (TA 100 with S9 mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test item in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- TA 1535, TA 100; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- TA 98; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537; without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- E. coli WP2 uvrA; without metabolic activation
- Details on test system and experimental conditions:
- -> 1st EXPERIMENT:
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 hours
NUMBER OF REPLICATIONS:
-Three plates per condition
DETERMINATION OF CYTOTOXICITY
- Method: other: Toxicity detected by a decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), or reduction in the titer
-> 2nd, 3rd and 4rd EXPERIMENT:
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48-72 hours
NUMBER OF REPLICATIONS:
- Three plates per condition
DETERMINATION OF CYTOTOXICITY
- Method: other: Toxicity detected by a decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), or reduction in the titer - Evaluation criteria:
- - The test chemical is considered positive in this assay if the following criteria are met: A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
- A test item is generally considered non-mutagenic in this test if the number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
- A weak bacteriotoxic effect (reduced his- or trp- background growth, slight decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed in the standard plate test depending on the strain and test conditions from about 2 550 μg/plate onward.
- In the preincubation assay bacteriotoxicity (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed depending on the strain and test conditions from about 500 μg/plate onward.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was found with and without S9 mix. - 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
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