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EC number: 234-324-0 | CAS number: 11099-06-2
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- other: secondary source
- Title:
- Subacute inhalation toxicity study in rats was performed to determine the toxic nature of the test chemical
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report ,2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Principles of method if other than guideline:
- Subacute inhalation toxicity study in rats was performed to determine the toxic nature of the test chemical.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3-aminopropyltriethoxysilane
- EC Number:
- 213-048-4
- EC Name:
- 3-aminopropyltriethoxysilane
- Cas Number:
- 919-30-2
- Molecular formula:
- C9H23NO3Si
- IUPAC Name:
- 3-aminopropyltriethoxysilane
- Details on test material:
- - IUPAC Name - 3-aminopropyltriethoxysilane
- InChI - 1S/C9H23NO3Si/c1-4-11-14(12-5-2,13-6-3)9-7-8-10/h4-10H2,1-3H3
- Smiles - [Si](CCCN)(OCC)(OCC)OCC
- Molecular formula :C9H23NO3Si
- Molecular weight :221.371 g/mole
- Substance type:Organ metallic
- Physical state:liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Details on test animal
- Age at study initiation:
101 to 153 grams
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Vehicle:
- air
- Details on inhalation exposure:
- The inhalation chambers used in the study were constructed of stainless steel with glass windows for animal observations. Chamber volume was 1330 liters and the airflow was approximately 300 L/min (13.5 air changes per hour). Chamber temperature and relative humidity were determined at least twelve times per exposure. The animals were acclimated to the chamber (air-only exposure) for 2 days prior to the initiation of the exposure regimen. The position of the cages was rotated daily within each chamber. Target concentrations of 0 and 150 mg/m3 were selected for this study. A 2% test substance hydrolysate solution was
prepared daily and used to generate the aerosol atmosphere in the inhalation chamber. Chamber concentrations of test substance hydrolysate were determined by gravimetric methods. The nominal concentration was calculated daily by dividing the total amount of material delivered to the chamber by the total airflow rate. The particle size distribution was measured once a day for the first 16 exposure days of the study. The data collected were analyzed by probit analysis (Finney, 1964) to obtain the mass median aerodynamic diameter (MMAD) and the geometric standard deviation - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 hours per day for a total of 19 exposures over 4 weeks
- Frequency of treatment:
- Five days/week for three weeks and four consecutive days during the fourth week
Doses / concentrations
- Remarks:
- 0 and 147 mg/m3
- No. of animals per sex per dose:
- Total:30
0 mg/m3:15 male
147 mg/m3:15 male - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Clinical observations were performed daily. All animals were weighed prior to study
initiation, weekly during the study, and immediately prior
to study termination - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Ten animals of the control and treated groups were subjected to a complete necropsy and the following tissues were fixed in 10% neutral buffered formalin for histologic evaluation: gross lesions, larynx, lungs, trachea, nasal turbinates and kidneys. For the satellite groups, the larynges of three control animals and five test substance-treated animals were taken and immersion-fixed in 2% glutaraldehyde for possible electron microscopic examination. The remaining two rats from thecontrol group were subjected to a complete necropsy and perfusion-fixed with 5% methanol-free EM grade fomaldehyde. The larynges from these two rats were then further immersion-fixed in 2% glutaraldehyde. Other organs (brain, spinal cord, and peripheral nerves) were taken from these control animals and processed for light microscopic evaluation.
- Statistics:
- The data for continuous, parametric variables were intercompared for the exposure and control groups by use of Levene's test for homogeneity of variances and by t-tests. If Levene's test indicated homogeneous variances, the groups were compared by pooled variance t-tests. If Levene's test indicated heterogeneous
variances, the groups were compared by separate variance t-test. Frequency data were compared using Fisher's exact tests. All statistical tests, except the frequency comparisons, were performed using BMDP Statistical Software (Dixon, 1985). The frequency data tests are described in Biometry (Sokal and Rohlf, 1969). The probability value of p < 0.05 (two-tailed) was used as the critical level of significance for all tests.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No exposure-related clinical signs were observed during the study.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A depression in body weight gain was observed for the test substance-exposed animals during the first week of the study.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- At necropsy, focal/multifocal color changes of the lungs were noted in ninety percent of the animals of the test substance-exposed group.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histological examination showed nonspecific irritant, inflammatory, and metaplastic changes within the respiratory tracts of test substance-exposed rats.
Laryngeal lesions included squamous metaplasia and foci of minimal granulomatous laryngitis. Other microscopic changes included the presence of cytoplasmic hyalinization (mild to moderate) within the olfactory mucosa, squamous metaplasia (minimal to mild) within the nasal mucosa, cellular hyperplasia within the trachea, alveolar histiocytosis, bronchopneumonia, interstitial pneumonitis and alveolar type II pneumocyte hyperplasia within the lungs - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 147 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No observed Adverse Effect concentration (NOAEC) for the test chemical using male rats was considered to be 147mg/m3
- Executive summary:
The subacute inhalation toxicity study of test chemical was performed in maleFischer 344 rats . Target concentrations of 0 and 150 mg/m3 were selected for this study. A 2% test substance hydrolysate solution was prepared daily and used to generate the aerosol atmosphere in the inhalation chamber. Chamber concentrations of test substance hydrolysate were determined by gravimetric methods. The nominal concentration was calculated daily by dividing the total amount of material delivered to the chamber by the total airflow rate. 15 rats per group were exposed to test chemical 6 hours per day for a total of 19 exposures over 4 weeks. Clinical observations were performed daily. All animals were weighed prior to study initiation, weekly during the study, and immediately prior to study termination. Ten animals of the control and treated groups were subjected to a complete necropsy and the following tissues were fixed in 10% neutral buffered formalin for histologic evaluation: gross lesions, larynx, lungs, trachea, nasal turbinates and kidneys. For the satellite groups, the larynges of three control animals and five test substance-treated animals were taken and immersion-fixed in 2% glutaraldehyde for possible electronmicroscopic examination. The remaining two rats from the control group were subjected to a complete necropsy and perfusion-fixed with 5% methanol-free EM grade fomaldehyde. The larynges from these two rats were then further immersion-fixed in 2% glutaraldehyde. Other organs (brain, spinal cord, and peripheral nerves) were taken from these control animals and processed for light microscopic evaluation. No exposure-related clinical signs and mortality were observed during the study. A depression in body weight gain was observed for the test substance-exposed animals during the first week of the study. At necropsy, focal/multifocal color changes of the lungs were noted in ninety percent of the animals of the test substance-exposed group. Histological examination showed nonspecific irritant, inflammatory, and metaplastic changes within the respiratory tracts of test substance-exposed rats. Laryngeal lesions included squamous metaplasia and foci of minimal granulomatous laryngitis. Other microscopic changes included the presence of cytoplasmic hyalinization (mild to moderate) within the olfactory mucosa, squamous metaplasia (minimal to mild) within the nasal mucosa, cellular hyperplasia within the trachea, alveolar histiocytosis, bronchopneumonia, interstitial pneumonitis and alveolar type II pneumocyte hyperplasia within the lungs. HenceThe No observed Adverse Effect concentration (NOAEC) for the test chemical using male rats was considered to be 147mg/m3
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