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EC number: 445-890-5 | CAS number: 201290-01-9
- 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:
- 19 March 2003 to 10 April 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- 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:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 445-890-5
- EC Name:
- -
- Cas Number:
- 201290-01-9
- Molecular formula:
- C14H37NO2Si3
- IUPAC Name:
- 7-ethoxy-2,2,7-trimethyl-3-(trimethylsilyl)-8-oxa-3-aza-2,7-disiladecane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: dissolved in arachis oil BP
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test material was freshly prepared as a solution at the appropriate concentration in arachis oil BP.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd., UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: +/- 20 % of the mean initial bodyweight of the first treated group
- Fasting period before study: an overnight fast immediately before dosing and three to four hours after dosing
- Housing: housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: free access to Certified Rat and Mouse diet, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15/ hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200, 30 and 30 mg/ml
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg was chosen as the starting dose in the absence of data suggesting the test material was toxic. - Doses:
- 2000, 300 and 300 mg/kg bw
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for deaths or signs of toxicity at 30 min, 1, 2 and 4 hours after dosing and once daily thereafter. Individual body weights were recorded prior to dosing and 7 and 14 days after treatment or death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathological examination of major organs - Statistics:
- Not used
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two animals treated with 2000 mg/kg bw died one day after dosing. No deaths occurred at a dose level of 300 mg/kg bw.
- Clinical signs:
- Hunched posture, lethargy, ataxia, decreased respiratory rate and laboured respiration were observed in animals treated with 2000 mg/kg bw. No signs of systemic toxicity were noted in animals treated with 300 mg/kg bw.
- Body weight:
- All the surviving animals showed the expected body weight gain except for one animal treated at a dose level of 300 mg/kg bw, which showed a body weight loss during the second week of the study.
- Gross pathology:
- Abnormally red lungs, dark liver and dark kidneys were noted at necropsy in animals that died during the study period. No abnormalities were noted at necropsy in animals that were killed at the end of the study period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In the acute oral toxicity study, conducted according to OECD TG 423 and in compliance with GLP, the estimated LD50 value was in the range of 500 - 1000 mg/kg bw.
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