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EC number: 234-028-1 | CAS number: 10497-05-9
- 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity in vitro - Ames( OECD TG 471): negative
Link to relevant study records
- 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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted: July 21, 1997 (OECD, 1997) corrected on 26 June 2020
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Provided by sponsor, Batch No.: N200611031
- Purity:99.28%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigeration (+2 to +8ºC) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 :
The S9 homogenate is prepared from male Wistar rats induced with a single intraperitoneal injection of Aroclor 1254 (0.5 mL to 0.7 mL/rat ready to use solution), 5 days prior to sacrifice.
- method of preparation of S9 mix :
The S9 homogenate will be thawed immediately before use and mixed with the co-factor solution containing 4 mM NADP, 5 mM Glucose-6-phosphate, 8 mM MgCl2 and 33 mM KCl in PBS to achieve a final concentration of 10% S9 (v/v) fraction in the activation mixture.
- concentration or volume of S9 mix and S9 in the final culture medium
a final concentration of 10% S9 (v/v) fraction in the activation mixture. - Test concentrations with justification for top dose:
- In the preliminary toxicity test, Salmonella typhimurium, TA 100 was exposed to test item at 50, 100, 200, 400, 800, 1600, 3200 and 5000 µg/plate along with DMSO control using direct plate incorporation method.
The results of this preliminary toxicity test are presented in Table 1.
The test item did not precipitate on the basal agar plates up to 5000 µg/plate.
The test item did not show toxicity at any of the tested doses either in the presence or in the absence of metabolic activation as the intensity of the bacterial background lawn as well as the mean number of revertant colonies were comparable to the vehicle control plates.
Based on these observations, it is decided to test the OECD 471-recommended highest test dose of 5000 µg/plate in the mutation assay. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: [DMSO]
- Justification for choice of solvent/vehicle:
Since DMSO is one of the organic solvents which is most compatible with the positive controls used, with good reproducibility and reliability
- Justification for percentage of solvent in the final culture medium: - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration:Three replicates
- Number of independent experiments :1
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 1-2 x 109 cells/mL.
- Test substance added in medium; in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: approximately 20 to 30 minutes at 37 ± 1 ºC
- Exposure duration/duration of treatment: incubated at 37 ± 1 °C for 48 to 72 hours
FOR GENE MUTATION:
- Expression time (cells in growth medium between treatment and selection): 48 to 72 hours.
- Number of cells seeded and method to enumerate numbers of viable and mutants cells: Viable counts for the different bacterial strains on nutrient agar plates will be counted manually.
- Evaluation criteria:
- The conditions necessary for determining a positive result are, there should be a dose related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing doses of the test item either in the presence or absence of the metabolic activation system.
The test will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value for the strains TA98, TA100 and WP2uvrA (pKM101) or equal to or greater than 3 times the mean vehicle control value for the strains TA1535 and TA1537.
An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose responsive increase that does not achieve the respective threshold cited above or a non-dose responsive increase that is equal to or greater than the respective threshold cited. A response will be evaluated as negative, if it is neither positive nor equivocal. - Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Conclusions:
- It is concluded that the test item, TRIS (TRIMETHYLSILYL) PHOSPHATE is not mutagenic in this Bacterial Reverse Mutation Assay up to the highest OECD 471-recommended dose of 5000 µg/plate, under the conditions of testing employed.
- Executive summary:
In a reverse gene mutation assay in bacteria (G20741), strains TA98, TA100, TA1535 and TA1537 of S. typhimurium and strain Escherichia coli: WP2uvrA (pKM101) were exposed to Tris(trimethylsilyl) phosphate(99.28%), at concentrations of 50,158 , 500, 1581 and 5000 µg/plate in the presence and absence of mammalian metabolic activation using the pre-incubation method.
The test item did not show toxicity to the tester strain at any of the tested doses as the intensity of the bacterial background lawn and the mean number of revertant colonies was comparable to the vehicle control plates. The test item did not precipitate on the basal agar plates at any of the tested doses up to 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.Based on these observations, is concluded that the test item, Tris(trimethylsilyl) phosphate is not mutagenic in this Bacterial Reverse Mutation Assay up to the highest OECD 471-recommended dose of 5000 µg/plate, under the conditions of testing employed.
This study is classified as acceptable . This study satisfies the requirement for Test Guideline OPPTS 870.51001; OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames test (OECD471)
In a reverse gene mutation assay in bacteria (G20741), strains TA98, TA100, TA1535 and TA1537 of S. typhimurium and strain Escherichia coli: WP2uvrA (pKM101) were exposed to Tris(trimethylsilyl) phosphate(99.28%), at concentrations of 50,158 , 500, 1581 and 5000 µg/plate in the presence and absence of mammalian metabolic activation using the pre-incubation method.
The test item did not show toxicity to the tester strain at any of the tested doses as the intensity of the bacterial background lawn and the mean number of revertant colonies was comparable to the vehicle control plates. The test item did not precipitate on the basal agar plates at any of the tested doses up to 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.Based on these observations, is concluded that the test item, Tris(trimethylsilyl) phosphate is not mutagenic in this Bacterial Reverse Mutation Assay up to the highest OECD 471-recommended dose of 5000 µg/plate, under the conditions of testing employed.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.51001; OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Justification for classification or non-classification
Based on the available data, the test item does not need to be classified for genotoxicity in accordance with the criteria outlined in EU CLP (EC no. 1272/2008 and its updates).
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