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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 701-065-4 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- other: Human exposure data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Basic data given, meets generally accepted scientific standards, acceptable for assessment. Justification for read-across is warranted given the similarities in toxicity profile and physico-chemical properties for silicon dioxide and magnesium silicate.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
- Reference Type:
- publication
- Title:
- No information
- Author:
- Langendorf H, Lang K
- Year:
- 1 967
- Bibliographic source:
- Zeitschrift fuer Ernaehrungswissenschaft, 8, 27-32
Materials and methods
- Endpoint addressed:
- basic toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Study in volunteers: Oral ingestion of an SAS amount in a drink, determination of Si in urine prior and after to administration.
- GLP compliance:
- no
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
- Details on test material:
- Aerosil, CAS-Name: Silica, amorphous, fumed, cryst.-free; CAS-No. 112945-52-5
FK 700, Silica, amorphous, precipitated, crystalline-free, CAS No. 112926-00-8
Constituent 1
Method
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): 2.5 g of test substance in 0.5 L (apple juice)
VEHICLE
- Concentration in vehicle: 0.5 %
- Amount of vehicle (if gavage): 0.5 L
Results and discussion
- Results:
- Aerosil - urinary excretion: <0.5 % of the dose applied within 4 days p.a.
FK 700 - urinary excretion: <0.5 % of the dose applied within 4 days p.a.
Any other information on results incl. tables
Daily urinary excretion of SiO2in volunteers before and after ingestion of synthetic amorphous silica
Aerosil |
||||||
Test person |
1 |
2 |
3 |
10 |
11 |
12 |
Sum SiO2day 1 – 3 [mg/d] (control) |
34.5 |
86.9 |
62.8 |
40.4 |
25.3 |
36.2 |
Sum SiO2day 4 – 7 [mg/d] |
32.3 |
64.5 |
61.3 |
60.8 |
44.5 |
52.9 |
FK 700 |
||||||
Test person |
4 |
5 |
6 |
7 |
8 |
9 |
Sum SiO2 |
42.4 |
36.8 |
71.4 |
16.1 |
39.9 |
27.4 |
Sum SiO2 |
52.2 |
57.0 |
81.4 |
20.4 |
58.3 |
21.8 |
During the four days post-treatment, significant changes of the renal SiO2 excretion were not seen.
Daily SiO2 increments in urine after ingestion ranged between individually 7 and 23 mg, but were barely distinguishable
from the baseline level.
Aerosil:
The individual baseline values of the pretest phase were very variable and individually different, mean excretion rates ranging from
25 to 87 mg/d. In the post-treatment phase, individual mean excretion rates ranged from 32 to 61 mg/d.
FK 700:
The individual baseline values of the pretest phase were very variable and individually different, mean excretion rates ranging
from 16 to 71 mg/d.
In the post-treatment phase, individual mean excretion rates ranged from 20 to 81 mg/d.
---------------
Overall, increases in excretion of SiO2 after oral ingestion were not
unequivocally detectable.
The small apparent increases on the average of less than 0.5 % of the total dose were in marked contrast to the high dose of 2500 mg SiO2 applied.
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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.
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