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EC number: 945-327-8 | CAS number: -
- 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:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- Silicon dioxide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- NM-200, synthetic amorphous silicon dioxide, precipitated. Cas number: 112926-00-8.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar outbred (Crl:WI(Han) strain.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to the authors, conditions in the animal room were kept under standard laboratory conditions.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methylhydroxypropylcellulose (MHCP)
- Details on exposure:
DIET PREPARATION
- Rate of preparation of diet (frequency): Once weekly
- Mixing appropriate amounts with (Type of food): Rodent breeding diet
- Storage temperature of food: Ambient temperature
VEHICLE
- Justification for use and choice of vehicle (if other than water): Not specified
- Concentration in vehicle: 0.5 % v/v of MHPC in Ultrapure water
- Amount of vehicle (if gavage): Not specified
- Lot/batch no. (if required): Not specified
- Purity:Not specified- Details on mating procedure:
- - M/F ratio per cage: 1 M/1 F
- Length of cohabitation: 2 weeks mating period
- Proof of pregnancy: sperm in vaginal smear, referred to as day 0 of gestation - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males were exposed during a 10 week pre-mating period, during mating and up to the day before termination. Females were exposed during a 10 week pre-mating period, during mating, gestation and lactation up to postnatal day 21. F1-pups were dose from postnatal day 22 until termination.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- 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 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
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- According to the authors, synthetic amorphous silica NM-200 had no effects on reproduction of the parental F0 and F1 animals.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: See "Remarks"
- Remarks on result:
- other: See "Remarks"
- Remarks:
- The study concludes that synthetic amorphous silica NM-200 generated no effects on reproduction of F0 and F1 generations nor had any developmental effects on the F1 and F2 pups, nor on the sexual maturation of the F1 weanlings.
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Basis for effect level:
- other: See "Remarks"
- Remarks on result:
- other: See "Remarks"
- Remarks:
- The study evaluated the reproduction toxicity of synthetic amorphous silica in rats over two generations. Included in the study were a F0-, F1- and a F2-generation.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- 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 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
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- A statistically significant decreased relative weight of the thyroid of the male animals of the mid-dose group of the F1-
generation was observed. - Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- other: According to the authors, the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg body weight per day. No toxicological-relevant differences were observed in exposed rats compared to controls in any generation.
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: See "Remarks"
- Remarks on result:
- other: See "Remarks"
- Remarks:
- The study concludes that synthetic amorphous silica NM-200 generated no effects on reproduction of F0 and F1 generations nor had any developmental effects on the F1 and F2 pups, nor on the sexual maturation of the F1 weanlings.
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No effects on the development of the F2 pups.
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- According to the authors, the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg body weight per day. No toxicological-relevant differences were observed in exposed rats compared to controls in any generation.
- Generation:
- F2
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: See "Remarks"
- Remarks on result:
- other: See "Remarks"
- Remarks:
- The study concludes that synthetic amorphous silica NM-200 generated no effects on reproduction of F0 and F1 generations nor had any developmental effects on the F1 and F2 pups, nor on the sexual maturation of the F1 weanlings.
Target system / organ toxicity (F2)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The study concludes that synthetic amorphous silica NM-200 generated no effects on reproduction of F0 and F1 generations nor had any developmental effects on the F1 and F2 pups, nor on the sexual maturation of the F1 weanlings. The NOAEL was found to be at 1000 mg/kg body weight per day.
- Executive summary:
An oral two-generation reproduction toxicity study with synthetic amorphous silicon dioxide (NM-200) was performe with Wistar rats. Animals were exposed to 100, 300 and 1000 mg/kg body weight/day by gavage. Male animals were exposed during a 10 -week premating period and during mating and to the day of sacrifice. Females were exposed during a 10 -week premating period and during mating, gestation and lactation up to postnatal day 21. Selected F1 -pups were exposed from postnatal day 22 and up to the day of sacrifice. Throughout the study the animals were daily checked for clinical signs and abnormal behaviour. Taken together, exposure to synthetic amorphous silica Nm-200 over two generations at concentrations up to 1000 mg/kg body weight/day had no effects on reproduction of the parental F0 and F1 generations nor on the development of the F1 and F2 pups, nor on the sexual maturation of the F1 weanlings. The NOAEL was found to be at 1000 mg/kg body weight per day.
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