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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no data on test material purity is given; use of 4 animals per sex per dose level
- 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:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Fasting period before study: none
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: trunk
- Type of wrap if used: impervious sheeting
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Constant volume used: no - Duration of exposure:
- 24 h
- Doses:
- Males:
- 8.0, 11.3, and 16.0 ml/kg bw as stated in the study report
- volumes applied correspond to doses of 8400, 11 865, and 16 640 mg/kg bw (converted from ml/kg bw based on a density of 1.05 g/ml, see IUCLID Section 4.4)
Females:
- 4.0, 8.0, and 16.0 ml/kg bw as stated in the study report
- volumes applied correspond to doses of 4200, 8400, and 16 800 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:
- 4
- 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 on 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:
- 16 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 8.43 - 30.6
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 16 800 mg/kg bw
- 95% CL:
- 8 851.5 - 32 130
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.04 g/ml, see IUCLID Section 4.4
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 11.3 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 5.09 - 25.2
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 11 865 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 344.5 - 26 460
- Remarks on result:
- other: converted from ml/kg bw based on a density of 1.04 g/ml, see IUCLID Section 4.4
- Mortality:
- Males:
8 ml/kg bw: 0/4
11.3 ml/kg bw: 0/4
16 ml/kg bw: 2/4
Females:
4 ml/kg bw: 0/4
8 ml/kg bw: 1/4
16 ml/kg bw: 3/4 - Clinical signs:
- other: Males: 8 ml/kg bw: none noted 11.3 ml/kg bw: unsteady gait at day 1 16 ml/kg bw: prostration of 2 animals at day 1 Females: 4 ml/kg bw: none noted 8 ml/kg bw: none noted 16 ml/kg bw: prostration at day 1 No further details are given in the study report
- Gross pathology:
- Males:
8 ml/kg bw: tracheae red; lungs of 1 was deep maroon
11.3 ml/kg bw: lungs of 2 were deep maroon
16 ml/kg bw: in animals found dead discoloured lungs (red or salmon) were observed; in survivors tracheae with red patches were observed; 1 bladder was filled with dark yellow fluid.
Females:
4 ml/kg bw: tracheae of 2 red, lungs of 2 with deep maroon patches
8 ml/kg bw: lungs of 1 mottled with with tan caseous nodules; lungs of 1 deep maroon; heart of 1 with white film like appearance on pericardial sac (histopathology revealed bronchopneumonia, pleuritis, pericarditis)
16 ml/kg bw: tracheae of 3 with dark red patches throughout; lungs of 1 mottled; liver of 1 mottled; bladder of 1 with dark fluid - Other findings:
- - Local effects
Males:
8 ml/kg bw: edema, erythema, fissuring, desquamation
11.3 ml/kg bw: edema, erythema, fissuring, desquamation
16 ml/kg bw: edema, erythema, fissuring, desquamation
Females:
4 ml/kg bw: edema, erythema, fissuring, desquamation
8 ml/kg bw: edema, erythema, fissuring, desquamation, pus-filled nodules over dosed area
16 ml/kg bw: edema, erythema, fissuring, scabs
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 tested for acute dermal toxicity according to a test protocol that is comparable to the OECD TG 402, but without GLP compliance. The test material was occlusively administered to 4 New Zealand White rabbits each sex and dose group for 24 h. The doses applied were 8400, 11 865 and 16 800 mg/kg bw for males and 4200, 8400, and 16 800 mg/kg bw for females, respectively. The LD50 was determined to be 16 800 mg/kg bw (males) and 11 865 (females) mg/kg bw. The predominant clinical signs detected were unsteady gait and prostration, as well as local effects, such as oedema, erythema and desquamation. Gross pathology revealed red tracheae; lungs deep maroon, lungs mottled with with tan caseous nodules, and heart with white film like appearance on pericardial sac (histopathology revealed bronchopneumonia, pleuritis, pericarditis). Based on this data, classification for acute dermal toxicity according to 67/584/EEC and EC/1272/2008 is not warranted.
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