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EC number: 231-545-4 | CAS number: 7631-86-9
- 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:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 958
- Report date:
- 1958
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 2 dose l, 18 hrs/d, 5 d/wk
21-Day dermal exposure study - GLP compliance:
- no
- Limit test:
- 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:
- dioxosilane
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- CAS 112945-52-5, Pyrogenic, Surface area / BET [m2/g] 175-225
Constituent 1
- Specific details on test material used for the study:
- Cab-O-Sil
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- albino
- Details on species / strain selection:
- 1.5 - 1.9 kg
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Throughout the study the animals were housed individually in metal cages elevated above the droppings. Food, consisting of Purina Rabbit Pellets and water, was available at all times.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- methylcellulose
- Details on exposure:
- on intact and abraded skin (2 animals each per dose group) in 0.5 % methyl cellulose
- Duration of treatment / exposure:
- 3 wks
- Frequency of treatment:
- 18 h/d, 5 d/wk
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 2
- Control animals:
- yes, concurrent vehicle
- other: positive control: cosmetic talc
- Positive control:
- #1625 Cosmetic talc (10 g/kg bw/d)
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In general the animals of each control and test group exhibited mild erythema and mild to moderate atonia consistently throughout the experimental period. From the beginning of the second week until tne time of sacrifice the exposed skin of each animal showed mild or moderate desquamation. Among the control and test rabbits with abraded skin areas, there appeared to be complete healing of the skin during each week foilowing the periodic abrasions. The skin immediately surrounding the abrasions showed a slightly greater degree of erythema than the remaining exposed skin. Otherwise, the degree of irritation was comparable among the intact and abraded skin animals of each group.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- one death in control group
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The majority of the animals in test groups receiving CAB-O-SIL gained weignt at a normal rate throughout the experimental period. The initial weight loss among several animals in the control groups was attributed to the initial challenge from infection; however during the latter part of the study these animals showed gains in body weight.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Examination of the analytical data shows that there was no significant difference in the silicon dioxide content of urine, blood, kidney, liver or spleen between the control and test animals.
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Examination of the analytical data shows that there was no significant difference in the silicon dioxide content of urine, blood, kidney, liver or spleen between the control and test animals.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At gross autopsy performed following sacrifice the livers of the majority of the animals contained parasitic areas which resembled coccidiosis. In addition the mesentery of one animal contained parasitic cysts resembling larval tapeworm cysts.Otherwise the organs of each animal appeared grossly within normal limits.
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- effects observed in control and treated groups
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 10 000 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
During the first two weeks several animals, particularly from the negative and positive control groups, exhibited diarrhoea and weight loss. From experience in this laboratory these findings suggested an intestinal infection, probably coccidiosis, and the involved animals were given one to three daily intramuscular injections of Streptomycin. Most of the animals responded to the antibiotic therapy with subsequent weight gains and disappearance of the diarrhoea. The single death that occurred in the negative control group on the 13th day was attributed to the challenge from infection. Except for the challenge from infection, the appearance and behaviour of each control and experimental animal were essentially normal.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions employed there was no evidence of systemic toxicity or of gross or microscopic pathology which could be associated witn application of CAB-O-SIL. The silicon dioxide content of blood, urine, spleen, liver, and kidney was comparable for control arid test animals.
Each control material and CAB-O-SIL produced a mild dermal irritation consisting of erythema, atonia, and desquamation. There appeared to be no significant difference in dermal irritative potential between the methyl cellulose solution, #1625 Cosmetic.Talc and CAB-O-SIL. - Executive summary:
The 21d dermal toxicity potential of Cab-O-SIL was examined in rabbits.
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