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EC number: 221-337-1 | CAS number: 3069-33-8
- 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:
- 17 June 2002 to 05 Mar 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[3-(methoxydimethylsilyl)propyl]ethylenediamine
- EC Number:
- 221-337-1
- EC Name:
- N-[3-(methoxydimethylsilyl)propyl]ethylenediamine
- Cas Number:
- 3069-33-8
- Molecular formula:
- C8H22N2OSi
- IUPAC Name:
- (2-aminoethyl)[3-(methoxydimethylsilyl)propyl]amine
- Details on test material:
- - Name of test material (as cited in study report): VP 50991
- Physical state: colourless liquid
- Stability under test conditions: > 1 day (4°C, in the dark) if vehicle is free of water
- Storage condition of test material: at room temperature, dry, tightly closed, dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: 41 (males) or 48 (females) days
- Weight at study initiation: 202 - 229 g (males); 171 - 182 g (females)
- Fasting period before study: yes (16 h before administration)
- Housing: 2-3 animals per cage during the 14-day observation period (MAKROLON cages, type III)
- Diet: ssniff/R/M-H V 1530 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55± 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 June 2002 To: 22 Aug 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- used only for 200 mg/kg bw dose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 90.91 mg/ml
- Amount of vehicle (if gavage): 2.2 ml
MAXIMUM DOSE VOLUME APPLIED: 2.2 ml - Doses:
- 200 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg bw: 3 males
200 mg/kg bw: 3 males and 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, at 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days (once daily). Body weight was determined before administration and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Changes of skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern were observed at least once daily until all symptoms subsided (afterwards each working day).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- 200 mg/kg bw: 0/3 males and 0/3 females died
2000 mg/kg bw: 2/3 males died within 2 days - Clinical signs:
- 2000 mg/kg bw: reduced motility, ataxia, reduced muscle tone, and dyspnoea
200 mg/kg bw: no signs of toxicity were observed - Body weight:
- All surviving animals gained the expected body weight.
- Gross pathology:
- No abnormalities were observed.
Any other information on results incl. tables
Table 1: Body weights of the surviving rats.
Body weights (g) |
2000 mg/kg bw |
200 mg/kg bw |
|
|
male |
male |
female |
start |
221.0 |
203.3 |
176 |
after 7 days |
278.0 ± 26.4 |
269 ± 32.6 |
200.3 ± 14.1 |
after 14 days |
319.0 ± 45.0 |
302.7 ± 48.9 |
222.0 ± 26.2 |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity study conducted according to OECD 423 and in compliance with GLP, a LD50 cut-off value of 1000 mg/kg bw was observed in rats. Mortality was observed in the high dose group (2/3 males died within 2 days), whereas no mortality occurred in the 200 mg/kg bw dose group (0/3 males and 0/3 females). Clinical signs of toxicity at 2000 mg/kg bw were reduced motility, ataxia, reduced muscle tone, and dyspnoea. In surviving animals no clinical signs were observed.
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