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nonapotassium 2,4,6-trihydroxy-4-methyl-3,5-dioxa-2,4,6-trisilaheptane-2,6-bis(olate) 2,6,8-trihydroxy-4,6-dimethyl-3,5,7-trioxa-2,4,6,8-tetrasilanonane-2,4,8-tris(olate) 6-hydroxy-2,4,6-trimethyl-1,3,5,2,4,6-trioxatrisilinane-2,4-bis(olate) dihydroxy(methyl)silanolate {[dihydroxy(methyl)silyl]oxy}(hydroxy)methylsilanolate
EC number: 935-877-7 | 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2002-09-27 to 2002-11-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. It is considered that read-across to the registered substance is scientifically justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Trimethoxy(methyl)silane
- EC Number:
- 214-685-0
- EC Name:
- Trimethoxy(methyl)silane
- Cas Number:
- 1185-55-3
- IUPAC Name:
- trimethoxy(methyl)silane
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy
- Age at study initiation: no information
- Weight at study initiation: 20.8-27.2 g
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study: no
- Housing: 5 animals per cage, polycarbonate with stainless steel mesh lid and floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: not given To: 2002-10-04
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: prepared immediately before use in corn oil
- Frequency of treatment:
- Single treatment
- Post exposure period:
- Samples taken at 24 or 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (corn oil), 500, 1000, and 2000 mg/kg
Basis:
other: expressed i terms of material as received. Solutions prepared on w/v basis without correction for displacement
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - mitomycin C
- Justification for choice of positive control(s): none given, standard control
- Route of administration: ip injection
- Doses / concentrations: 3.0 mg/lg body weight
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: preliminary toxicity assay
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): no additional information
DETAILS OF SLIDE PREPARATION: air dried and stained with May-Gruenwald and Giesma
METHOD OF ANALYSIS: 200 PCEs per animal examined for presence of micronuclei at high power (x100, oil immersion)
OTHER: - Evaluation criteria:
- A test item is considered positive if it induces a statistically significant increase, exceeding the historical range of negative control values, in the incidence of micronucleated PCEs (p<0.05) in pooled data for both sexes or for either sex considered separately.
- Statistics:
- Original observations of polychromatic cells from control and treated groups were compared using a modified Chi-squared evaluation
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
Any other information on results incl. tables
Animals from the high dose treatment group showed reduced activity, ataxia and hunched posture. Animals from the intermediate dose treatment group showed hunched posture and an animal died after treatment. Clinical signs and mortality were observed and provided evidence of bioavailability of the test substance and adequate exposure time. Following treatment with the test substance, no statistically significant increase in the incidence of micronucleated PCE's over the control value was observed at any dose-level, at any sampling time. Following treatment with the positive control Mitomycin-C, statistically significant increases in the incidence of micronucleated PCEs over the control values were observed, indicating the correct functioning of the test system.
The test was conducted at the limit dose of 2000 mg/kg bw at which signs of toxicity were seen (mortality, reduced activity, ataxia and hunched posture) indicating bioavailability of the test substance. When tested at the limit dose with no or minimum signs of toxicity and with the positive and negative controls responding appropriately, the test is considered valid.
The ratio of mature to immature to immature erythrocytes and the proportion of immature erythrocytes to among total erythrocytes were analyzed to evaluate the bone marrow cell toxicity. No inhibitory effect on erythropoetic cell division was observed for either sex at any sampling time.
The report contains the values for PCE and NCE separately, as well as ratios of NCE/PCE and PCE/(NCE+PCE). P/N ratios were not calculated in the report.
Dose |
PCE |
NCE |
NCE/PCE ratio |
PCE/(NCE+PCE) |
0 |
20527 |
25105 |
1.22 |
0.45 |
500 |
20601 |
22891 |
1.11 |
0.47 |
1000 |
18525 |
21590 |
1.17 |
0.44 |
2000 |
20504 |
26333 |
1.28 |
0.44 |
Positive control |
20847 |
35393 |
1.69 |
0.37 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Trimethoxy(methyl)silane has been tested in a valid study according to OECD 474 and under GLP. No increase in the indicence of micronucleated PCE was observed resulting from exposure to the test substance by oral gavage up to limit concentrations. It is concluded that the test substance is negative for the induction of micronuclei under the conditions of the test.
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