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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-10-8 to 2009-11-17
- 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.
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
- Objective of study:
- other: determination of systemic availability
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 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
- Radiolabelling:
- no
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: none reported
- 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 exposure:
- PREPARATION OF DOSING SOLUTIONS:
Each dosing solution was prepared individually: 125 mg/ml, 250 mg/ml, 500 mg/ml. Dose volume was 4 ml/kg body weight. Dosing solutions were not analysed.
Storage conditions
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. - Duration and frequency of treatment / exposure:
- Single gavage dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 500, 1000, 2000 mg/kg bw
- No. of animals per sex per dose / concentration:
- 8 (4 each for blood sampling at 2 h and 5 h post-dosing)
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- No
- Details on study design:
- - Dose selection rationale: none given (possibly based on phase 1 and 2 preliminary studies but no data are given)
- Rationale for animal assignment: after release from quarantine/acclimation, animals were weight stratified by sex then randomized into groups using Provantis™ v8.2. Animals were within ± 20% of the mean body weight for each sex. - Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled : blood
- Time and frequency of sampling: 2 h and 5 h post-dosing
METABOLITE CHARACTERISATION STUDIES
None - Statistics:
- Standard error of means only.
Results and discussion
- Preliminary studies:
- Phases 1 and 2 were conducted without GLP to refine the analytical approach for the main study (phase 3). Data from these preliminary studies are not included in the report.
Main ADME results
- Type:
- other: systemic availability
- Results:
- 1,6- bis(trimethoxysilyl)hexane and/or its derivatives were systemically available based on the total silicon content detected in the plasma at 2 h and 5 h post dosing.
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- See table 1.
The report notes: 1,6-Bis(TMS)H is a hydrolytically active alkoxysilane and as such absorption from the gastrointestinal (GI) tract of various derivative molecular species (i.e., hydrolysis products. metabolites, and conjugation products) was possible. In order to more broadly assess systemic availability of the test article following absorption from the GI tract, the total silicon (Si) content in plasma was determined using inductively coupled plasma-optical emission spectroscopy (ICP OES) rather than selecting for a specific derivative molecular species. The units were expressed as µg equivalents of 1 ,6-Bis(TMS)H. The limit of quantitation was 4.8 µg equivalents of 1,6- Bis(TMS)H/g plasma.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Table 1: Observed silicon concentration ( μg equivalents of 1,6-bis(trimethoxysilyl)hexane per g plasma)
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 μg equivalents of 1,6-bis(trimethoxysilyl)hexane
Reviewer's note: the use of μg equivalents of parent substance may be misleading as the extent of hydrolysis prior to absorption may lead to absorption of hydrolysis product; the μg equivalents of the hydrolysis product 1,6-bis(trihydroxysilyl)hexane would be lower. For example, 100 μg equivalents of 1,6-bis(trimethoxysilyl)hexane would be 74 μg equivalents of 1,6-bis(trihydroxysilyl)hexane.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: not possible to comment based on the data presented
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 resulted in the presence of silicon in the blood sampled at 2 and 5 hours after dosing. Blood silicon concentrations were generally higher at 2 h than at 5 h, and higher in males than females. No other toxicokinetic evaluations were made.
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