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EC number: 945-544-8 | CAS number: -
- 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
- Study period:
- 03 April 2017 to 26 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- bis(trimethoxysilylpropyl)methylphosphonate
- Molecular formula:
- C13H33O9PSi2
- IUPAC Name:
- bis(trimethoxysilylpropyl)methylphosphonate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light, under nitrogen and with desiccant
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was dissolved in DMSO.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: All test substance dilutions were prepared using screw-capped tubes in the glove box nitrogen. After completing the dilution in the glove box under nitrogen, 1.5 mL of each group was aliquoted into another vial to make total of two vials for each group. Test substance dilutions were prepared immediately before use and delivered to the test system at room temperature under filtered light.
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- bacteria, 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:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- An initial toxicity-mutation assay was used to establish the dose range for the main mutagenicity assay and to provide a preliminary mutagenicity evaluation.
33.3, 100, 333, 1000, 3333 and 5000 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: anhydrous DMSO
- Justification for choice of solvent/vehicle: Chosen based on solubility of the test item and compatibility of the target cells.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION: The S9 was miex with the following co-factors: 4 mM of β-nicotinemide-adenine dinucleotide phosphate, 5 mM glucose-6-phosphate, 33 mM potassium chloride, 8 mM magnesium chloride, 100 mM phosphate buffer (pH 7.4), 10% (v/v) S9 homogenate. The mixture containing 100 mM phosphate buffer at pH 7.4 was also prepared on the day of use.
DURATION
- Preincubation period/exposure duration: 20 min
- Expression time (cells in growth medium): 48 to 72 hours
NUMBER OF REPLICATIONS: duplicate cultures
DETERMINATION OF CYTOTOXICITY
- Method: background lawn
- Any supplementary information relevant to cytotoxicity: not specified - Rationale for test conditions:
- An initial toxicity-mutation assay was used to establish the dose range for the main mutagenicity assay and to provide a preliminary mutagenicity evaluation.
- Evaluation criteria:
- For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test substance as specified below:
- Strains TA98, TA1535, TA1537 and WP2 uvrA: data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3 times the mean vehicle control value and the above corresponding acceptable vehicle control range.
- Strains TA100: data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2 times the mean vehicle control value and the above corresponding acceptable vehicle control range. - Statistics:
- Not used
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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 applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not specified
- Effects of osmolality: not specified
- Evaporation from medium: not specified
- Water solubility: not specified
- Precipitation: not observed
RANGE-FINDING/SCREENING STUDIES: The results of the initial toxicity-mutation assay conducted at dose levels of 1.50, 5.00, 15.0, 50.0, 150, 500, 1500 and 5000 µg/plate. Neither precipitate nor toxicity was observed. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
HISTORICAL CONTROL DATA
- Positive historical control data: within the ranges of positive control data
- Negative (solvent/vehicle) historical control data: within the ranges of negative control data
Any other information on results incl. tables
Table 1: Summary results from mutagenicity assay with and without metabolic activation
Concentration μg/plate |
TA98 |
|
TA100 |
|
TA1535 |
|
TA1537 |
|
WP2uvrA |
|
|
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
5000 |
24 |
10 |
71 |
94 |
12 |
11 |
13 |
9 |
29 |
20 |
3333 |
25 |
15 |
90 |
104 |
15 |
12 |
12 |
8 |
26 |
16 |
1000 |
22 |
19 |
90 |
89 |
16 |
11 |
10 |
13 |
31 |
21 |
333 |
25 |
16 |
98 |
78 |
16 |
11 |
12 |
7 |
29 |
19 |
100 |
22 |
16 |
98 |
93 |
9 |
15 |
12 |
7 |
30 |
21 |
33.3 |
22 |
12 |
80 |
84 |
19 |
12 |
11 |
8 |
29 |
24 |
DMSO 50.0 |
22 |
15 |
88 |
90 |
18 |
10 |
11 |
11 |
27 |
20 |
2NF 1.0 |
|
124 |
|
|
|
|
|
|
|
|
SA 1.0 |
|
|
|
513 |
|
467 |
|
|
|
|
9AAD 75.0 |
|
|
|
|
|
|
|
211 |
|
|
MMS 1000 |
|
|
|
|
|
|
|
|
|
419 |
2AA 1.0 |
298 |
|
|
|
87 |
|
|
|
|
|
2AA 2.0 |
|
|
851 |
|
|
|
59 |
|
|
|
2AA 15.0 |
|
|
|
|
|
|
|
|
348 |
|
2NF: 2-nitrofluorene
SA: sodium azide
9AAD: 9-aminoacridine
MMS: methylmethanesulfonate
2-AA: aminoanthrecene
Applicant's summary and conclusion
- Conclusions:
- Reaction Mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethylphosphonate] has been tested in a valid bacterial reverse mutation assay, according to the OECD TG 471 (1997), and in compliance with GLP, using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 or WP2uvrA. No increase in the number of revertants was observed in any test strain, with or without metabolic activation when tested up to limit concentration. Appropriate positive and solvent controls were added and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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