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Diss Factsheets
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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- repeated dose toxicity: dermal, other
- Remarks:
- Repeated sub-acute, dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Report from year 1958 (Cabot, unpublished report).
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- ECETOC (2006)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
- Principles of method if other than guideline:
- Dermal toxicity and irritative potential of pyrogenic silicon dioxide was studied using the rabbit as a test organism. Exposure followed a serie of 15 applications to intact and abraded skin.
- GLP compliance:
- not specified
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:
- Hydrophilic synthetic amorphous silicon dioxide, pyrogenic (Cab-O-Sil fluffy), CAS 112945-52-5.
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on species / strain selection:
- Albino, strain not specified.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Two males, two females.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on exposure:
- Doses administred were 0, 5000, 10 000 mg/kgbw/d in a serie of 15 applications to intact and abraded skin.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 h per day, 5 days per week over three weeks.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 5 000 mg/kg bw/day
- Dose / conc.:
- 10 000 mg/kg bw/day
- Dose / conc.:
- 10 000 mg/kg bw/day
- Remarks:
- + ve control (cosmetic talc).
- No. of animals per sex per dose:
- Two males and two females were included in the study.
- Control animals:
- yes
- Details on study design:
- Doses administred were 0, 5000, 10 000 mg/kgbw/d in a serie of 15 applications to intact and abraded skin. Rabbits were exposed for 18 h per day, 5 days per week over a three week period.
- Positive control:
- Methylcellulose
Examinations
- Observations and examinations performed and frequency:
- Systemic toxicity.
Gross or microscopic pathological changes.
Silica content of blood, urine, spleen, liver and kidney.
Dermal irritation (erythema, stonia, desquamation).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No evidence of systemic toxicity.
- Dermal irritation:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No significant difference in dermal irritation between control and dose groups.
- Gross pathological findings:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- other:
- Sex:
- male/female
- Remarks on result:
- other: See "Remarks"
- Remarks:
- As summarized in ECETOC (2006), no toxicity of synthetic amorphous silicon dioxide was seen by the dermal route of expsoure.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
The silica content of blood, urine, spleen, liver and kidney of treated animals was comparable to that of controls.
Applicant's summary and conclusion
- Conclusions:
- Data available indicate no toxicity of synthetic amorphous silicone dioxide (pyrogenic) in rabbit by the dermal route of exposure.
- Executive summary:
Repeated sub-acute toxicity of synthetic amorphous silicone dioxide (pyrogenic) by the dermal route of exposure was evaluated in rabbit. Males and females were exposed to 0, 5000 and 10 000 mg/kgbw/d substance in a serie of 15 applications (18 h/day, five days/week over a period of three weeks). Methylcellulose and cosmetic talc were used as positve and negative controls, respectively. No evidence of systemic toxicology or gross or microscopic pathological changes in control and dose groups. No difference in silica content of blood and investigated organs between control and dose groups. No significant difference in dermal irritation between control and dose groups.
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.
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