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EC number: 232-263-4 | CAS number: 7803-62-5
- 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:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The study was well documented and meets generally accepted scientific principles, but there was no information on whether it was conducted in compliance with GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute and subacute inhalation toxicity of silane 1000 ppm in mice
- Author:
- Omae K, Sakai T, Sakurai H, Yamazaki K, Shibata T, Mori K, Kudo M, Kanoh and Tati M
- Year:
- 1 992
- Bibliographic source:
- Archives of Toxicology 66: 750-753
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- Only males and one concentration used. No urinalysis. Food and water consumption not measured.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Silane
- EC Number:
- 232-263-4
- EC Name:
- Silane
- Cas Number:
- 7803-62-5
- Molecular formula:
- H4Si
- IUPAC Name:
- silane
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Details on species / strain selection:
- None specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: Five weeks
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: Five animals per transparent plastic cages with stainless steel wire-lined ceilings.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 60
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: No data
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Animals were exposed in a tightly sealed 550 l stainless steel inhalation chamber with glass windows.
- Method of holding animals in test chamber: None
- Source and rate of air: filtered room air (no further details)
- Method of conditioning air: HEPA filter (no further details)
- Temperature, humidity, pressure in air chamber: No data
- Air flow rate: No data
- Air change rate: No data
- Treatment of exhaust air:
TEST ATMOSPHERE
- Brief description of analytical method used: Gas chromatography (no further details)
- Samples taken from breathing zone: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Silane concentrations were monitored at ten minute intervals using a gas chromatograph.
- Duration of treatment / exposure:
- 14 or 28 days
- Frequency of treatment:
- Six hours/day, five days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- Ten males
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: 1) the concentration was 200 or 2000 times higher than the recommended TWA exposure limits by many countries, 2) sufficient to adversely affect the health of the mice, 3) the effect of oxygen deficiency on the mice would not need to be taken into account.
- Rationale for animal assignment (if not random): No data
- Rationale for selecting satellite groups: No satellite groups
- Post-exposure recovery period in satellite groups: No post-exposure recovery group
- Section schedule rationale (if not random): No data - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were monitored for several days before exposure. The schedule during exposure was not reported.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Assumed to be prior to sacrifice, but not stated in report.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: All
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Assumed to be prior to sacrifice, but not stated in report.
- Animals fasted: No data
- How many animals: All
- Parameters checked in table 1 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 2)
HISTOPATHOLOGY: Yes (see table 2) - Statistics:
- No information.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Immediately after being exposed to silane on each day of exposure, most mice began to perform face washing movements and lick the lower abdomen for short periods.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- There were no deaths.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Average daily weight gains (ADWG) from Monday morning to Friday morning (four days exposure) were always smaller in exposed than nonexposed mice, but were not statistically significant. ADWG from Friday morning to Monday morning (one day of exposure and two days nonexposure), was greater in exposed than nonexposed mice (statistically significant in 3/4 week) (see Table 3).
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- White blood cell counts, lymphocytes, and nonsegmented neutrophils were increased significantly in animals exposed for four weeks (see Table 4).
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no effects on organ weights.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Mucous exudates and inflammatory and/or necrotic cells were observed in the nasal cavity more frequently in mice exposed for four weeks than in nonexposed mice, but the changes were mild.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- > 1 000 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant adverse effects.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 3 Average daily weight gain (Friday to Monday morning)
Week 1 -2 (n=20) | Week 2 -3 (n=10) | Week 3 -4 (n=10) | |
Exposed | 0.35 ± 0.26 | 0.44 ± 0.25 | 0.59 ± 0.17* |
Nonexposed | 0.46 ± 0.14 | 0.47 ± 0.14 | 0.27 ± 0.17 |
*p<0.01
Table 4 Summary of haemaology results.
Parameter | Nonexposed | Exposed |
Alkaline phosphatase | 56 ± 12 | 52.± 12 |
Aspartate aminotransferase | 69 ± 22 | 61 ± 14 |
Alanine aminotransferase | 19 ± 6 | 23 ± 10 |
Cholinesterase | 364 ± 96 | 376 ± 87 |
Blood urea nitrogen | 40 ± 5 | 35 ± 9 |
Sodium | 167 ± 3 | 168 ± 5 |
Potassium | 6.3 ± 1.4 | 7.1 ± 1.6 |
Red blood cell | 926 ± 46 | 951 ± 54 |
White blood cell | 25 ± 9 | 40 ± 14* |
Stab | 0.5 ± 0.2 | 1.1 ± 0.6* |
Steg | 5.2 ± 2.2 | 5.5 ± 1.9 |
Lymphocytes | 19.2 ± 8.2 | 32.9 ± 13.6* |
Monocytes | 0.1 ± 0.1 | 0.2 ± 0.3 |
*p<0.05
Taken from publication - no further details, such as units.
Applicant's summary and conclusion
- Conclusions:
- In a well conducted 14/28 day inhalation study (reliability score 2; no information on GLP status) conducted using a protocol similar to OECD 412, the NOAEL was greater than 1000 ppm (6 h/d, 5d/wk; the only concentration tested).
- Executive summary:
In a well conducted 14/28 day inhalation study (reliability score 2; no information on GLP status) conducted using a protocol similar to OECD Test Guideline 412, male ICR mice (n=10/group) were exposed to 1000 ppm silane for 6 hours/day, 5 days/week for 4 weeks. These treatments did not induce mortality. Mild irritation manifested in the form of a small amount of exudate in 8/10 animals and inflammation and/or necrosis of the cells of the nasal mucosa were observed in 6/10 animals. No histopathological changes were observed in the trachea, lung or cornea. Regarding haematology/biochemical parameters, there was a statistically significant increase in white blood cell (lymphocytes and neutrophils only) counts. The NOAEC was therefore greater than 1000 ppm.
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