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EC number: 402-810-3 | CAS number: 17980-47-1 DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.10.1994 to 04.11.1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Sex of animals not given, some environmental conditions not given.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Triethoxyisobutylsilane
- EC Number:
- 402-810-3
- EC Name:
- Triethoxyisobutylsilane
- Cas Number:
- 17980-47-1
- Molecular formula:
- Hill formula: C10H24O3Si CAS formula: C10H24O3Si
- IUPAC Name:
- triethoxy(2-methylpropyl)silane
- Details on test material:
- - Name of test material (as cited in study report): Isobutyltriethoxysilane
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: No data
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 309-577 g
- Housing: Groups of 1 to 6 in propylene boxes.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 05.10.1994 to 04.11.1994
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil
- Concentration / amount:
- Induction injection: 5%
Epicutaneous applications: 30%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- Induction injection: 5%
Epicutaneous applications: 30%
- No. of animals per dose:
- Test: 20
Negative control: 10
Positive control: 10 - Details on study design:
- RANGE FINDING TESTS: Approximately 24 hours prior to the preliminary test, fur was removed from both flanks by shaving. There was no abrasion. Two guinea pigs were used in a preliminary study to determine the non-necrotic intradermal concentration of the test substance in sesame oil. A volume of 0.1 ml of the test substance at concentrations of 1.25, 2.5 and 5% was injected intradermally on the flank of each guinea pig. No necrosis was observed at any concentration. Therefore the concentration of 5% was selected for the intradermal induction.
Two guinea pigs were used to determine the maximum subirritant concentration and the irritating concentration under occlusive conditions. 0.5 ml of 100, 75, 50 and 30% w/w concentrations of test substance were applied on patches to the flank under occlusion for 24 hours. The maximum subirritant concentration was found to be 30%, while at 100% the test substance was found to be mildly irritating. Therefore these two concentrations were used for the epidermal challenge and epidermal induction, respectively.
MAIN STUDY
A. INDUCTION EXPOSURE
On Day 1, two intradermal injections of 5% test substance in sesame oil and 1:1:1 mix of saline:FCA:30% w/w test substance in sesame oil were made on the shaved cervical area (5x5 cm) of each animal. On Day 8, 2 ml of test substance was applied epicutaneously to the same site on a patch and occluded for 48 hours. The control group was treated in the same way without the application of the test substance.
B. CHALLENGE EXPOSURE
Three weeks after the last induction, test and control groups were challenged on one flank with a 30% w/w solution of test substance in sesame oil. A volume of 0.5 ml of solution was applied on a patch to the shaved flank and occluded for 24 hours with Micropore Tape. The skin reactions were scored according to Draize. - Challenge controls:
- 30% w/w solution of test substance in sesame oil under occlusion for 24 hours.
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Study design: in vivo (LLNA)
- Statistics:
- None
Results and discussion
- Positive control results:
- 10/10 animals reacted positively. Twenty-four hours after patch removal the mean irritation score was 4.6, and at 48 hours, the mean irritation score was found to be 4.0.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% in peanut oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1% in peanut oil. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% in peanut oil
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1% in peanut oil. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30% in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30% in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30% in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30% in sesame oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% in sesame oil
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Grade 1 erythema after 24 hours in one animal.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% in sesame oil. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Grade 1 erythema after 24 hours in one animal. .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% in sesame oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% in sesame oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
No mortalities, clinical signs of toxicity or effects on body weight were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guinea pig maximisation study conducted to OECD 406, but not to GLP, triethoxyisobutylsilane was not sensitising to the skin (reliability score 2).
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