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Diss Factsheets
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EC number: 234-858-4 | CAS number: 12037-47-7
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- Start: 15 Oct. 1962
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment, acceptable as screening method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
- Principles of method if other than guideline:
- One-generation reproduction toxicity study with some deviations from the guideline: (number of animals and examinations to low (5 instead of 20 females), deficiencies in mating procedure (mating ratio 1:5 instead of 1:2, mating over 14 d, only 1 male used per treated and control group,) one (relatively low) dose only).
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- IUPAC Name:
- dioxosilane
- Details on test material:
- - Name of test material (as cited in study report): Aerosil, not further specified, hydrophilic: CAS-Name: Silica, amorphous, fumed, crystalline free, CAS-No. 112945-52-5
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Details on mating procedure:
- - M/F ratio per cage: 1:5
- Duration of treatment / exposure:
- Exposure period: 6 months
Premating exposure period (males): 4.5 months
Premating exposure period (females): 4.5 months
Duration of test: 6 months - Frequency of treatment:
- daily
- Details on study schedule:
- Number of generation studies: 1
Doses / concentrations
- Remarks:
- Doses / Concentrations:
497 mg/kg bw/day (m); 509 mg/kg bw/day (f)
Basis:
- No. of animals per sex per dose:
- 5 females
1 male per 5 females - Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
OTHER: Haematology on 5 animals of each group was conducted prior to exposure, each month and at the end of the study. - Litter observations:
- PARAMETERS EXAMINED
- external appearance and development - Postmortem examinations (parental animals):
- HISTOPATHOLOGY
On parental animals.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
Details on results (P0)
No haematological findings.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 497 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: NOAEL corresponding to the highest dose tested.
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 497 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: NOAEL corresponding to the highest dose tested.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.