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EC number: 810-490-5 | CAS number: 35501-23-6
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-butyl-N-[(triethoxysilyl)methyl]butan-1-amine
- EC Number:
- 810-490-5
- Cas Number:
- 35501-23-6
- Molecular formula:
- C15H35NO3Si
- IUPAC Name:
- N-butyl-N-[(triethoxysilyl)methyl]butan-1-amine
- Reference substance name:
- N,N-Dibutylaminomethyl-triethoxysilan
- IUPAC Name:
- N,N-Dibutylaminomethyl-triethoxysilan
- Test material form:
- other: liquid
- Details on test material:
- Name: N,N-Dibutylaminomethyl-triethoxysilan
CAS No: 35501-23-6
Lot No: 310113
Physical State: liquid
Colour: colourless to yellowish
Storage Conditions: at room temperature, protected from light,
protected from water/ humidity
Purity: 97.7% (GC)
Stability: rapid hydrolysis in water
Date of analysis: 31 January 2013
Expiry Date: 21 January 2015
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Species/strain: WISTAR rats Crl: WI(Han)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female (non-pregnant and nulliparous)
Number of animals: 3 per step
Age at the
beginning of the study: 8-12 weeks old
Report, BSL BIOSERVICE Study No.143950 page 15 of 26
Version: Final
Body weight on the
day of administration: Step 1: animals no.: 1 - 3: 166 - 171 g
Step 2: animals no.: 4 - 6: 155 - 164 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Preparation of the Animals:
The animals were marked for individual identification by tail painting. Prior to the administration a detailed clinical observation was made of all animals. Only healthy animals were used. Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
ENVIRONMENTAL CONDITIONS
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1526)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 02102140509)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 g of the test item were suspended with the vehicle to gain a final volume of 10 mL
- Amount of vehicle (if gavage): The test item was administered at a dose volume of 10 mL/kg body weight.
- Justification for choice of vehicle: Cotton seed oil was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): (Sigma-Aldrich, lot no. MKBN8713V, expiry date: 30 September 2014) - Doses:
- The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.
- No. of animals per sex per dose:
- Number of animals: 3 per step
- Control animals:
- no
- Details on study design:
- - Observation Period
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
- Weight Assessment
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Clinical Examination
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Pathology
The animal which had to be sacrificed for ethical reasons during the observation period was necropsied as soon as it was killed. At the end of the observation period the all animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial; lot no.: 236014; expiry date: 31 January 2014) at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000
- Based on:
- test mat.
- Remarks on result:
- other: A dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
- Mortality:
- Under the conditions of the present study, a single oral application of the test item N,N-Dibutylaminomethyl-triethoxysilan to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
- Clinical signs:
- No specific findings.
- Body weight:
- None of the animals showed weight loss during the observation period.
- Gross pathology:
- No specific findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item N,N-Dibutylaminomethyl-triethoxysilan to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
The median lethal dose of N,N-Dibutylaminomethyl-triethoxysilan after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): unclassified
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item
N,N-Dibutylaminomethyl-triethoxysilan has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item N,N-Dibutylaminomethyl-triethoxysilan has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) the test item N,N-Dibutylaminomethyl-triethoxysilan has no obligatory labelling requirement for toxicity and is not classified. - Executive summary:
SUMMARY RESULTS
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended with the vehicle cotton seed oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study without showing any test-item related signs of toxicity.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
On the basis of the test results given below and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC, the substance should be: not classified
On the basis of the test results given below and in conformity with the criteria given in Annex I of Regulation (EC) 1272/2008, the substance should be: not classified
Conclusion:
Under the conditions of the present study, a single oral application of the test item N,N-Dibutylaminomethyl-triethoxysilan to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
The median lethal dose of N,N-Dibutylaminomethyl-triethoxysilan after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): unclassified
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item
N,N-Dibutylaminomethyl-triethoxysilan has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item N,N-Dibutylaminomethyl-triethoxysilan has no obligatory labelling requirement for toxicity and is not classified.
According to GHS (Globally Harmonized Classification System) the test item N,N-Dibutylaminomethyl-triethoxysilan has no obligatory labelling requirement for toxicity and is not classified.
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