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EC number: 250-437-8 | CAS number: 31024-56-3
- 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
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- 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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (only limited information on test procedure and test material identity are given, and no test material purity is stated in the study report)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]butylamine
- EC Number:
- 250-437-8
- EC Name:
- N-[3-(trimethoxysilyl)propyl]butylamine
- Cas Number:
- 31024-56-3
- Molecular formula:
- C10H25NO3Si
- IUPAC Name:
- butyl[3-(trimethoxysilyl)propyl]amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: none
- Diet: appropriate diet ad libitum (not further specified)
- Water: ad libitum (not further specified)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg
- Doses:
- 0.5, 1, 2, 4, 8, and 16 mL/kg bw, equivalent to 475, 950, 1900, 3800, 7600, and 15200 mg/kg bw (calculated based on a density of 0.95 g/cm³)
- No. of animals per sex per dose:
- 5 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The LD50 along with the 95% confidence limits was calculated by the moving average method based on a 14 day observation period.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 12 825 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 551 - <= 3 192
- Remarks on result:
- other: (equivalent to 13.5 mL/kg bw (95% CL 5.38 - 33.6 mL/kg bw); calculated based on a density of 0.95 g/cm³)
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 475 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: (equivalent to 0.5 mL/kg bw; calculated based on a density of 0.95 g/cm³)
- Mortality:
- - 16 mL/kg bw: 3/5 (all animals died 30-35 min after dosing)
- 8 mLl/kg bw: 1/5 (animal died on day 7 post-dosing)
- 4 mL/kg bw: 2/5 (animals died 20 min after dosing and on day 1); repeated for confirmatory purpose: deaths 2/5 on days 0 and 1
- 2 mL/kg bw: 2/5 (deaths occured 15 and 20 min after dosing)
- 1 ml/kg bw: 1/5 (animal died 30 min after dosing)
- 0.5 mL/kg bw: 0/5 - Clinical signs:
- other: - 16 mL/kg bw: Sluggish (survivers) at 35 min; salivation - 8 mL/kg bw: Diarrhoea at day 1 - 4 mL/kg bw: Salivation; repeated for confirmatory purpose: Unsteady gait; salivation 5 min after dosing; survivors recovered after 1 day. - 2 mL/kg bw: Unsteady g
- Gross pathology:
- In victims, the stomach was gas-filled, the glandular portions were injected, and the intestines were injected or contained blood.
In survivors, nothing remarkable was observed.
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 oral toxicity according to a test protocol that is comparable to the appropriate OECD 401 test guideline, but without GLP compliance. The test material was administered by stomach intubation to 5 male rats each dose group. The LD50 was determined to be 12825 mg/kg bw. The predominant clinical signs detected were salivation, unsteady gait, sluggishness, and diarrhoea. No deaths and no clinical signs throughout the study period were observed at 425 mg/kg bw. Based on this data, classification for acute oral toxicity according to Regulation (EC) No. 1272/2008 is not warranted.
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