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EC number: 603-157-9 | CAS number: 12676-29-8
- 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
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:
- February - June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD TG and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Boron silicate
- EC Number:
- 603-157-9
- Cas Number:
- 12676-29-8
- Molecular formula:
- H7 B7 Si57 O128
- IUPAC Name:
- Boron silicate
- Details on test material:
- Name of test substance: silicon boride oxide
Homogeneity: given
Physical state/ Appearance: Solid / white
Storage conditions: Room temperature, protect against humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: about 8 weeks
- Housing: Groups up to 5
- Diet (e.g. ad libitum): mouse/rat laboratory diet “GLP”, 10 mm pellets (Provimi Kliba SA, Kaiseraugst, Basel Switzerland) ad libitum
- Water (e.g. ad libitum): and tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: conditioned air
- Remarks on MMAD:
- MMAD / GSD: MMAD was below 1 um (0.5-0.9um) for all air samples analyzed.
- Details on inhalation exposure:
- The test substance was used unchanged.
For each concentration the dust aerosol was generated with the dust generator and compressed air inside a mixing stage mixed with conditioned
dilution air and passed into the inhalation system.
The control group was exposed to conditioned air. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations of the inhalation atmospheres in test groups 1 - 3 were analyzed by gravimetric measurement. Daily means were calculated based on three measured samples per concentration and exposure. From the daily mean values of each concentration, mean concentrations and standard deviations for the entire study were derived. In these groups, the constancy of concentrations in the inhalation systems were continuously monitored using scattered light photometers. The control atmosphere was not sampled.
- Duration of treatment / exposure:
- 6 hours
- Frequency of treatment:
- each workday over 4 weeks (20 exposures)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
10, 50, 250 mg/m3
Basis:
other: target concentration
- Remarks:
- Doses / Concentrations:
10.5, 53.7, 243.5 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- other: yes, conditioned air
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: The clinical condition of the test animals was recorded once during the pre-exposure period and on post-exposure observation day and at least 3 times (before, during and after exposure) on exposure days. During exposure only a group wise examination was possible.
BODY WEIGHT: Yes
- Time schedule for examinations: The body weight of the animals was determined before the exposure period on study days -5 and -2, at the start of the exposure period on study day 0 and on study day 2. Afterward body weights were determined twice a week, as well as on the day before gross necropsy. As a rule, the animals were weighed at the same time of the day.
FOOD CONSUMPTION:
- Food consumption was determined weekly and calculated as mean food consumption in grams per animal and day.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: upon necropsy
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all
- The following parameters were checked: Leukocyte count, Erythrocyte count, Hemoglobin, Hematocrit, Mean corpuscular volume, Mean corpuscular hemoglobin, Mean corpuscular hemoglobin concentration, Platelet count, Differential blood count, Reticulocytes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: upon necropsy
- Animals fasted: Yes
- How many animals: all
- The following parameters were checked: ALT, AST, ALP, GGT, Sodium, Potassium, Chloride, Inorganic Phosphate, Calcium, Urea, Creatinine, Glucose, Total bilirubin, Total protein, Albumin, Globulins,Triglycerides, Cholesterol, Bile acids - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- At the end of the study in males of test group 10 mg/m3 absolute and relative large unstained cell counts were higher compared to controls, but this change followed no dose-dependency. Therefore, it was regarded as incidental and not treatment-related.
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Details on results:
- No mortalities or clinical signs were observed during the course of the stucy. No effects were observed on body weight and weight gain and food consumption. At the end of the study in males of test group 10 mg/m3 absolute and relative large unstained cell counts were higher compared to controls, but this change followed no dose-dependency. Therefore, it was regarded as incidental and not treatment-related. No changes were observed in clinical chemistry examinations.
The absolute and relative lung weight were increased in a dose-dependent manner (see table below); this effect was considered treatment-related. The absolute and relative spleen weights of females in the low dose group was reduced, however in the absence of dose-dependency and histological correlates, this finding was considered incidental and not treatment-related.
In histopathological examinations, treatment-related findings were observed in the lungs (see table below), mediastinal and tracheobronchial lymph nodes and in the nasal cavity at level I and III. The incidence and grading of these findings is given in the following tables. In the lungs, a multifocal inflammation was observed in all males and females of middle and high dose groups. The inflammation was localized in the lumen of the alveolar ducts and adjacent alveoli and was characterized by a predominant accumulation of macrophages (histiocytosis) and a less prominent and more irregular presence of neutrophilic granulocytes. In addition, the walls of the alveolar ducts appeared more or less thickened due to a minimal epithelial hypertrophy/hyperplasia. The affected alveolar ducts were regarded as part of the inflammatory process. Furthermore, the terminal bronchioles of all males and females of test groups 2 (50 mg/m3) and 3 (250 mg/m3) showed epithelial hypertrophy/hyperplasia, characterized by an increase in the size and number of epithelial cells.
The draining mediastinal and tracheobronchial lymph nodes of almost all males and females in test group 3 (250 mg/m³) and only 1 of 5 males of test
group 2 (50 mg/m³) were secondarily affected with multifocal macrophage aggregates.
In the nasal cavity in test group 3 (250 mg/m³), minimal hypertrophy/hyperplasia of the respiratory epithelium was found at level III affecting 3 out of 5 males and 4 out of 5 females, and minimal squamous metaplasia at level I, affected 2 out of 5 males. These changes were regarded as treatment-related.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Remarks:
- (local effects)
- Effect level:
- 10 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOAEC
- Remarks:
- (systemic effects)
- Effect level:
- 250 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Lung weights compared to controls
Lungs |
male animals |
female animals |
||||
Test group |
1 |
2 |
3 |
1 |
2 |
3 |
(mg/m3) |
(10) |
(50) |
(250) |
(10) |
(50) |
(250) |
absolute |
106% |
116% |
133%** |
106% |
119%* |
141%** |
relative |
107% |
113% |
137%** |
105% |
115% |
133%** |
Histological findings
Lungs |
Male animals |
Female animals |
||||||
Test group |
0 |
1 |
2 |
3 |
0 |
1 |
2 |
3 |
(mg/m3) |
(0) |
(10) |
(50) |
(250) |
(0) |
(10) |
(50) |
(250) |
animals examined |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
Inflammation, multifocal |
0 |
0 |
5 |
5 |
0 |
0 |
5 |
5 |
· Grade 1 |
|
|
4 |
|
|
|
5 |
|
· Grade 2 |
|
|
1 |
2 |
|
|
|
2 |
· Grade 3 |
|
|
|
3 |
|
|
|
3 |
Hypertrophy/hyperplasia, terminal bronchiole |
0 |
0 |
5 |
5 |
0 |
0 |
5 |
5 |
· Grade 1 |
|
|
5 |
|
|
|
5 |
|
· Grade 2 |
|
|
|
5 |
|
|
|
5 |
Microscopic findings in the nasal cavity
Lungs |
Male animals |
Female animals |
||||||
Test group |
0 |
1 |
2 |
3 |
0 |
1 |
2 |
3 |
(mg/m3) |
(0) |
(10) |
(50) |
(250) |
(0) |
(10) |
(50) |
(250) |
Animals examined |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
Level I |
|
|
|
|
|
|
|
|
Metaplasia, squamous |
0 |
0 |
0 |
2 |
|
|
|
|
· Grade 1 |
|
|
|
2 |
|
|
|
|
Level III |
|
|
|
|
|
|
|
|
Hypertrophy/hyperplasia, respiratory epithelium |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
4 |
· Grade 1 |
|
|
|
3 |
|
|
|
4 |
Applicant's summary and conclusion
- Conclusions:
- The NOAEC for local toxicity at the respiratory tract was 10 mg/m³ for male and female rats based on histological findings in nasal cavity, lung, mediastinal and tracheobronchial lymph nodes.
The NOAEC for general, systemic toxicity was 250 mg/m³ for the male and females rats.
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