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EC number: 216-467-0 | CAS number: 1591-02-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-01-2015 to 15-01-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dibutoxy(dimethyl)silane
- EC Number:
- 216-467-0
- EC Name:
- Dibutoxy(dimethyl)silane
- Cas Number:
- 1591-02-2
- Molecular formula:
- C10H24O2Si
- IUPAC Name:
- dibutoxydimethylsilane
- Test material form:
- other: liquid at room temperature
- Details on test material:
- - Name of test material (as cited in study report): Dibutoxy(dimethyl)silane
- Physical state: Liquid
- Stability under test conditions: undergoes hydrolysis in water, otherwise stable
- Storage condition of test material: at room temperature, protected from water and moisture, tightly closed and protected well from heat/ignition source
Constituent 1
Test animals / tissue source
- Species:
- other: bovine cornea
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not relevant
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not relevant
- Amount / concentration applied:
- Not relevant
- Duration of treatment / exposure:
- Not relevant
- Observation period (in vivo):
- Not relevant
- Number of animals or in vitro replicates:
- Not relevant
- Details on study design:
- Following preparation of the corneas, calibration of the opacitometer and an equilibration period the medium was removed from both chambers and replaced with fresh complete RPMI 1640 without phenol red. An initial opacity measurement was performed on each of the corneas using an opacitometer (MC2, Clermont, France). Three corneas with opacity readings approximately equivalent to the median opacity of all corneas were selected as negative-control corneas. The opacity of each cornea was read against an air-filled chamber and recorded. Corneas that have an initial opacity reading above 7 units were discarded. The medium was removed from the anterior chamber and replaced with the test item or control.
750 microlitres of the test substance or the control substance were introduced into the anterior chamber (closed-chamber method). After 10 minutes incubation at 32 ± 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber was refilled with complete RPMI and an opacity measurement was performed after 2 hours incubation at 32 ± 1 °C.
After the opacity measurement was performed, the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh complete RPMI. 1 mL of a 4 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 ± 1 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer.
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive control treated with ethanol 100%
The BCOP assay is considered to be valid if the in vitro irritation score obtained with the positive control falls within the two standard deviations of the current historical mean.
The negative control responses should result in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control (within two standard deviations of the current historical mean).
Results and discussion
In vivo
Results
- Irritation parameter:
- other: IVIS
- Remarks on result:
- other: IVIS = 2.51 (Not classified)
Any other information on results incl. tables
The mean in vitro irritation score was calculated to be 2.51.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.
The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control (within two standard deviations of the current historical mean).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an in vitro Bovine Corneal Opacity and Permeability Assay conducted to OECD TG 437 and GLP, the mean in vitro irritation score, based on opacity and permeability values, after 10 min of exposure and 2 h post incubation, was 2.51 for dibutoxy(dimethyl)silane. This result is negative for eye irritation potential.
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