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EC number: 280-084-5 | CAS number: 82985-35-1
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. No information is given on the test material purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (no data on test material purity is given)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Bis(trimethoxysilylpropyl)amine
- EC Number:
- 280-084-5
- EC Name:
- Bis(trimethoxysilylpropyl)amine
- Cas Number:
- 82985-35-1
- Molecular formula:
- C12H31NO6Si2
- IUPAC Name:
- 3,3,11,11-tetramethoxy-2,12-dioxa-7-aza-3,11-disilatridecane
- Details on test material:
- - Name of test material (as cited in study report): Organofunctional Silane Y-9492
- Physical state: clear, non-viscous liquid
- Lot/batch No.: 09989
- Identification: NB 2225-99
- BRRC Sample No.: 44-365
- Date of Receipt: 15 December 1981
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hilltop-Wistar albino rats
- Weight at study initiation: 200-300 g
- Fasting period before study: yes (overnight)
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The test material was administered undiluted, since it reacted quickly with water under formation of a hard mass.
MAXIMUM DOSE VOLUME APPLIED: 16.0 ml/kg bw - Doses:
- - 2.0, 4.0, 8.0, and 16.0 ml/kg bw as stated in the study report
- volumes applied correspond to doses of 2100, 4200, 8400, and 16800 mg/kg bw (converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animal weights were recorded at day 0 (prior to dosing), and at days 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- LD50 was calculated by the moving average method and is based on a 14 days observation period.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 - < 8 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Mortality: 2/5 (16 ml/kg bw); 0/5 (8 ml/kg bw); 2/5 (4 ml/kg bw)
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 4 200 - < 8 400 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3.6 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.8 - 6.9
- Remarks on result:
- other: Mortaility: 4/5 (16 ml/kg bw); 0/5 (8 ml/kg bw); 3/5 (4 ml/kg bw)
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 780 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 890 - 7 245
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4
- Mortality:
- Males:
- 16.0 ml/kg bw: 2/5 on days 2 and 5
- 8.0 ml/kg bw: 0/5
- 4.0 ml/kg bw: 2/5 on days 3 and 4
- 2.0 ml/kg bw: 0/5
Females:
- 16.0 ml/kg bw: 4/5 on days 1, 2, 2, and 6
- 8.0 ml/kg bw: 0/5
- 4.0 ml/kg bw: 3/5 on days 2, 3, and 8
- 2.0ml/kg bw: 0/5 - Clinical signs:
- other: Males: - 16.0 ml/kg bw: sluggishness at 5 min; unsteady gait at 2 h; prostration at 3 h; red, crusty discolouration on mouth and nose area at 1 day; survivors recovered at 2 days - 8.0 ml/kg bw: sluggishness at 5 min; recovery at 2 h - 4.0 ml/kg bw: gasp
- Gross pathology:
- Males:
- 16.0 ml/kg bw: in animals found dead: lungs dark red; stomachs filled with hard mass; in survivors: lungs dark red; lung of 1 male with white nodules
- 8.0 ml/kg bw: lungs with maroon patchy discolouration
- 4.0 ml/kg bw: in one animal found dead: dark red liver; in survivors: nothing remarkable
- 2.0 ml/kg bw: nothing remarkable was observed
Females:
- 16.0 ml/kg bw: in victims: lungs dark red; stomachs filled with hard mass; salivary glands with pus-filled nodule in one female; in survivors: lungs dark red; salivary glands enlarged
- 8.0 ml/kg bw: lungs mottled maroon and dark pink
- 4.0 ml/kg bw: in victims: lungs dark red; in survivors: lungs dark red; stomachs filled with hard mass
- 2.0ml/kg bw: nothing remarkable was observed - Other findings:
- The authors report that the test item reacted very quickly with water to form a hard mass. Since a hard mass in stomachs was noted at necropsy, which was assumed to be reacted sample material, the deaths were concluded to be most likely due to obstruction of the stomach and intestine.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was investigated for acute oral toxicity according to a protocol that is similar to the OECD TG 401, but without compliance with GLP. The test material was administered by stomach intubation to 5 Wistar rats each sex and dose group at doses of 2100, 4200, 8400, and 16 800 mg/kg bw. The LD50 was determined to be 4200-8400 mg/kg bw for males and 3780 mg/kg bw for females, respectively. The predominant clinical signs detected were sluggishness; unsteady gait; prostration; red, crusty discolouration on mouth and nose area; gaspping; salivation; and wheezing. Mean body weights were affected in high dose males and for females in all dose groups. Gross pathology revealed for animals found dead stomachs filled with hard mass; dark red lungs; or lungs with maroon pathy discolouration. One victim showed a dark red liver. Based on this data, classification for acute oral toxicity according to 67/584/EEC and EC/1272/2008 is not warranted.
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