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EC number: 617-969-6 | CAS number: 87135-01-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test conducted in accordance with generally accepted scientific standards, described in sufficient detail and with GLP, but limited compared to a standard guideline study since the study was terminate 5 hours after dosing.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study design was not based on a specific guideline. Its aim was to determine the systemic availability of 1,6- bis(trimethoxysilyl)hexane (test article and/or its derivatives) in rats following a single gavage dose.
- GLP compliance:
- yes
- Test type:
- other: non-guideline multi-dose acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 87135-01-1
- Molecular formula:
- C12H30O6Si2
- Reference substance name:
- 3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane
- EC Number:
- 617-969-6
- Cas Number:
- 87135-01-1
- Molecular formula:
- (CH3O)3Si(CH2)6Si(OCH3)3 C12 H30 O6 Si2
- IUPAC Name:
- 3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not stated
- Age at study initiation: 8 wk
- Weight at study initiation: 244-272 (m); 169-207 (f)
- Fasting period before study:
- Housing: 2/suspended wire mesh cage
- Individual metabolism cages: yes/no
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2-21.7
- Humidity (%): 41-63
- Air changes (per hr): 14.5 or 15.6 depending on room
- Photoperiod (hrs dark / hrs light):12 h/12/ h
IN-LIFE DATES: for main study From: 2009-10-19 To: 2009-10-20
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Each dosing solution was prepared individually: 125 mg/ml, 250 mg/ml, 500 mg/ml.
- Justification for choice of vehicle: none given
MAXIMUM DOSE VOLUME APPLIED: 4 mg/kg bw
DOSAGE PREPARATION: Each dosing solution was prepared individually: 125 mg/ml, 250 mg/ml, 500 mg/ml. Dosing solutions were not analysed.
The dosing solutions for the definitive study were prepared three days prior to experimental start and stored at room temperature.
HOMOGENEITY AND STABILITY OF TEST MATERIAL: No details. - Doses:
- 0, 500, 1000, 2000 mg/kg bw
- No. of animals per sex per dose:
- 8 (4 each for blood sampling at 2h and 5h post-dosing)
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: observation for survival only to 5 hours post dosing.
- Other examinations performed: none
- Blood samples taken at 2 h and 5 h after dosing for analysis of total silicon (see below).
Inductively coupled plasma-optical emission spectroscopy (ICP-OES) was used to determine the total silicon content in plasma rather than selecting for a specific derivative molecular species. The limit of quantitation was 4.8 µg equivalents of 1,6-bis(TMS)H/g plasma. The total silicon content detected in the plasma samples was significantly above the limit of quantitation for all dose groups at both blood collection time points, approximately two and five hours post dose administration. The group means and standard error of the mean were reported. - Statistics:
- Standard error of means only.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: survival to 5 hours after treatment
- Effect level:
- 2 000 mg/kg bw
- Remarks on result:
- other: non-standard acute study
- Mortality:
- 0/16 deaths during 5 hours after treatment at 2000 mg/kg bw.
- Clinical signs:
- other: not recorded
- Gross pathology:
- not examined
- Other findings:
- Blood silicon - see table 1.
Any other information on results incl. tables
Table 1: Observed silicon concentration (mg equivalents of 1,6-bis(trimethoxysilyl)hexane
Approximate time after dose administration |
Dose level (mg/kg bw) |
Males
|
Females |
2h |
0 |
<LOQ |
<LOQ |
500 |
65.3 +/-5.3 |
35.3 +/-4.4 |
|
1000 |
113.4 +/-11.3 |
73.2 +/-13.4 |
|
2000 |
235.3+/-43.7 |
130.2 +/-21.4 |
|
5h |
0 |
<LOQ |
<LOQ |
500 |
10.8 +/-1.0 |
15.2 +/-1.6 |
|
1000 |
24.1 +/-2.8 |
32.7 -/-2.3 |
|
2000 |
35.9 +/-3.2 |
25.6 +/-0.9 |
LOQ: limit of quantitation – 4.8 mg equivalents of 1,6-bis(trimethoxysilyl)hexane
Applicant's summary and conclusion
- Interpretation of results:
- other: cannot classify based on the data presented
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A well reported non-guideline study conducted according to GLP found that single oral doses of the test substance given to male and female rats caused no treatment-related mortality up to 5 hours after dosing despite the systemic availability of the test substance and/or its derivatives in the blood.
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