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EC number: 273-761-1 | CAS number: 69012-64-2 Amorphous silicon dioxide particles from the volatilization and vaporization of furnace feed materials in the manufacture of ferrosilicon and silicon.
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- No toxicological data were available for silica fume and, therefore, a read-across approach was used. The dissolution, composition and surface properties were the most important parameters considered when deciding which substances can be used for read-across.
Based on the composition, surface characteristics, and bioaccessibility data, silica fume was assumed to have toxicological properties similar to those of sparingly synthetic amorphous silicas. Therefore read-across was carried out using available toxicological studies with synthetic amorphous silica (SAS).
Details on the read-across approach are presented in Iuclid section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: dominant lethal assay
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Flow laboratories
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 300-350 g
- Fasting period before study: no data
- Housing: 1-5 rats / cage
- Diet (e.g. ad libitum): commercial 4% fat diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-11 days
ENVIRONMENTAL CONDITIONS: no data - Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on mating procedure:
- - M/F ratio per cage: 1 M / 2 F
- Length of cohabitation: 5 days
- After 2 days of rest, the male rat was housed with two other females for 5 days. This was repeated for 8 weeks (7 weeks in the subacute study).
- After successful mating each pregnant female was caged (how): 2 feamles / cage - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Acute: single administration, subacute: 5 days.
- Frequency of treatment:
- One dose per day.
- Details on study schedule:
- The females were killed 14 days after separation from the males.
- Remarks:
- Doses / Concentrations:
15, 150, 1500, 5000 mg/kg bw
Basis:
nominal conc. - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control:
- Triethylene melamine
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data - Litter observations:
Corpora lutea, early fetal deaths, late fetal deaths, total implantations per uterine horn.- Statistics:
- t-tests, regression analyses, Freeman-Tukey transformations, chi-square test, Armitage's trend.
- Reproductive indices:
- fertility index, average number of implantations, average corpora lutea, average preimplantation losses, average resorptions, dead implants/total implants
- Clinical signs:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 5 000 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: Dominant lethal test negative.
- Remarks on result:
- other: Dominant lethal test negative
- Basis for effect level:
- other: reprotoxicity
- Remarks on result:
- other: not specified
- Reproductive effects observed:
- not specified
- Conclusions:
- Calcium silicate did not have any fertility effects in rats studied by the dominant lethal assay.
- Executive summary:
The toxicity of calcium silicate was studied by the dominant lethal assay after exposure of male rats given with oral doses up to 5000 mg/kg for 1 or 5 days (Litton 1974). No differences in fertility index, preimplantation losses or embryo resorptions were observed between the calcium silicate groups and the control animals.
Data source
Materials and methods
Test material
- Reference substance name:
- Fumes, silica
- EC Number:
- 273-761-1
- EC Name:
- Fumes, silica
- Cas Number:
- 69012-64-2
- Molecular formula:
- SiO2
- IUPAC Name:
- silanedione
- Details on test material:
- - Name of test material (as cited in study report): high grade silica fume; low grade silica fume
- Analytical purity: high grade: SiO2 96.4% (w/w); low grade: SiO2 83.8% (w/w)
Constituent 1
Results and discussion
Applicant's summary and conclusion
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