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EC number: 402-580-4 | CAS number: 111439-76-0 ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
- 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
- Study period:
- 14 December 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with EC Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- Only 3M/3F per dose group.
- Principles of method if other than guideline:
- The study was performed according to EC-test guidelines, which provided an animal number of 5F/5M per dose group. Divergent from that, only 3M/3F animals per dose group were employed in the study, since this procedure leads to equivalent results.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Isobutylisopropyldimethoxysilane
- EC Number:
- 402-580-4
- EC Name:
- Isobutylisopropyldimethoxysilane
- Cas Number:
- 111439-76-0
- Molecular formula:
- Hill formula: C9H22O2Si
- IUPAC Name:
- dimethoxy(2-methylpropyl)(propan-2-yl)silane
- Details on test material:
- IUPAC name: Dimethoxyisobutylisopropyl silane
ZK 119.649 (TZ 01748), batch no. W87/138 (certificate of analysis no. 87/003, dated Jan. 26, 1988).
Stability of ZK 119.649: stored in closed vessels, at room temperature at least stable till Apr./May 1988
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar-Han-Schering
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering
- Age at study initiation: No data
- Weight at study initiation: (I): 79 to 98 g, (IIa): 76 to 91 g, (IIb): 95 to 117 g
- Fasting period before study: 18.5 to 19.5 hours
- Housing: Conventional
- Diet (e.g. ad libitum): pell. Altromin R ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 52-66%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Isotonic sodium chloride solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): Control groups: 1.25 mL vehicle/kg or 2.5 mL vehicle/kg
- Justification for choice of vehicle: No information
- Lot/batch no. (if required): Batch no. KL 150 A2
- Purity: 1L contains 9.0 g sodium chloride
MAXIMUM DOSE VOLUME APPLIED: No data - Doses:
- Two doses: 1.09 mg/kg bw/day (female only) and 2.18 mg/kg bw/day ( male and female)
- No. of animals per sex per dose:
- 1.09 mg/kg bw/day: 3 female
Control (1.25 mL vehicle/kg): 3 female
2.18 mg/kg bw/day: 3 female + 3 male
Control (2.5 mL vehicle/kg): 3 female + 3 male - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighings on day 1, day 8 and day 14. Clinical observations performed on day 1, 30 mins, 1.5 hr and 3hr after exposure and then daily.
- Necropsy of survivors performed: yes
- Other examinations performed: None - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 180 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 090 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female animal treated with 2.18 g ZK 119.649/kg died on day 3 of the test.
- Clinical signs:
- other: other: The main findings after application of ZK 119.649/kg in male and female animals were apathy, disturbances in gait and breathing, eyelid closure (incomplete), ruffled fur and wet fur sticking together. Male animals revealed, additionally, lateral po
- Gross pathology:
- In animals which died before the end of the observation period: In animal no. 11F which died on day 3 of the study a yellowish mucous content within the small intestine as well as a reddening of mucosa of the urinary bladder were observed.
In animals sacrificed at the end of the observation period: none - Other findings:
- None
Any other information on results incl. tables
Application schedule of ZK 119.649 and rate of mortality:
Dose (g/kg) |
No. of animals, sex |
Observation period after administration (time of administration) |
D/U |
1.25 mL vehicle /kg (control) |
3 F |
25 Aug to 7 Sept 1987 (9:55 to 10:10) |
0/3 |
1.09 |
3F |
0/3 |
|
2.5 mL vehicle /kg (control) |
3M |
11 Aug to 24 Aug 1987 (9:55 to 10:05) |
0/3 |
2.18 |
3M |
0/3 |
|
2.5 mL vehicle /kg (control) |
3F |
13 Aug to 26 Aug 1987 (11:00 to 11:15) |
0/3 |
2.18 |
3F |
1/3 |
D: No. of dead animals
U: No. of animals used
Clinical findings after application of 2.18 g ZK 119.649/kg in male rats
Dose (g/kg) |
Findings |
Number of animals with findings/number of surviving animals |
|||||
Day 1 + 30 min |
Day 1 + 1.5 hr |
Day 1 + 3 hr |
Day 2 |
Day 3 |
Days 4 - 14 |
||
2.5 mL/kg vehicle (control) |
without findings |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
2.18 |
apathy, slight apathy, severe lateral position conscious gait, atactic gait, severely atactic tremor, total, spontaneous respiration, irregular incomplete eyelid closure fur, ruffled fur, wet, sticking together without findings |
3/3
3/3 |
3/3
0/3 |
3/3
1/3
0/3 |
1/3 1/3 1/3
1/3 1/3 1/3 1/3 2/3 0/3 |
2/3 1/3 |
3/3 |
Clinical findings after application of 2.18 g resp. 1.09 g ZK 119.649/kg in female rats
Dose (g/kg) |
Findings |
Number of animals with findings/number of surviving animals |
|||||
Day 1 + 30 min |
Day 1 + 1.5 to 2 hr |
Day 1 + 3 to 3.5 hr |
Day 2 |
Day 3 |
Days 4 - 14 |
||
1.25 mL/kg vehicle (control) |
without findings |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
1.09 |
gait, atactic without findings |
3/3 |
3/3 |
3/3 0/3 |
3/3 |
3/3 |
3/3 |
2.5 mL/kg vehicle (control) |
without findings |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
2.18 g |
apathy, severe prone, lateral or supine position in state of unconsciousness gait, atactic gait, severely atactic disturbances in breathing incomplete eyelid closure dacryorrhea, slight fur, wet, sticking together fur, ruffled without findings |
3/3 |
3/3
2/3 0/3 |
1/3 2/3
2/3 0/3 |
1/3 1/3
1/3 1/3 1/3 1/3
0/3 |
2/2 |
2/2 |
Body weight in g at the start (day 1), day 8 and day 14 of the test in male rats
Dose (g/kg) |
No. of animals, sex |
Animal nos. |
Day 1 X/SD |
Day 8 X/SD |
Day 14 X/SD |
2.5 mL/kg vehicle (control |
3 M |
1 M 2 M 3 M |
91/4 |
149/2 |
183/10 |
2.18 |
3 M |
4 M 5 M 6 M |
89/10 |
144/11 |
180/13 |
Body weight in g at the start (day 1), day 8 and day 14 of the test in female rats
Dose (g/kg) |
No. of animals, sex |
Animal nos. |
Day 1 X/SD |
Day 8 X/SD |
Xi |
Day 14 X/SD |
Xi |
1.25 mL/kg vehicle (control |
3 F |
1 F 2 F 3 F |
107/11 |
150/4 |
|
|
161/7 |
1.09 |
3 F |
4 F 5 F 6 F |
111/5 |
152/5 |
|
|
166/6 |
2.5 ml vehicle/kg (control) |
3 F |
7 F 8 F 9 F |
85/8 |
137/11 |
|
150/12 |
|
2.18 |
3 F |
10 F 11 F 12 F |
88/3 |
|
136
124 |
|
149
144 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 determination after a single i.g. application of ZK 119.649 yielded in male rats a dose > 2.18 g ZK 119.649/kg and in female rats a dose > 1.09 g/kg, presumably close to 2.18 g ZK 119.649/kg. No clear cut differences between surviving male and female animals of dose group 2.18 g/kg were observed in respect of clinical observations, body weight gain and autopsy findings.
Derived from the findings of the present study it is concluded that the LD50 in the rat is > 2 g/kg. Therefore, ZK 119.649 is not classified as "harmful'. - Executive summary:
For the toxicological characterization of ZK 119.649 an acute toxicity study with approximate LD50 determination in rats (M+F) was
to be performed after a single intragastric (i.g.) application.
The LD50 determination after a single i.g. application of ZK 119.649 yielded in male rats a dose > 2.18 g ZK 119.649/kg and in female rats a dose > 1.09 g/kg, presumably close to 2.18 g ZK 119.649/kg. No clear cut differences between surviving male and female animals of dose group 2.18 g/kg were observed in respect of clinical observations, body weight gain and autopsy findings.
Derived from the findings of the present study it is concluded that the LD50 in the rat is > 2 g/kg. Therefore, ZK 119.649 is not classified as "harmful'.
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