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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Exposure related observations in humans: other data

Administrative data

exposure-related observations in humans: other data
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
no data
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted standards, sufficiently documented, acceptable for assessment.
Justification for type of information:
Test material ist different from reference substance but comparable, see chapter 13, attachment 'Analogue Approach Justification'
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
read-across source

Data source

Reference Type:
Der Einfluss polymerer Kieselsaeuren auf die renale SiO2-Ausscheidung beim Menschen.
Langendorf, H. and Lang, K.
Bibliographic source:
Zeitschrift fuer Ernaehrungswissenschaft 8, 27-32

Materials and methods

Type of study / information:
Excretion of FK700 in humans.
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
Six human volunteers received two doses of FK700 in apple juice. The urine was collected daily and analysed for the monomer SiO2 content (according to Baumann 1960).
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicon dioxide
EC Number:
EC Name:
Silicon dioxide
Cas Number:
Molecular formula:
Silicon dioxide
Constituent 2
Reference substance name:
Synthetic Amorphous Silica (SAS)
Synthetic Amorphous Silica (SAS)
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
Trade name: NM-200, a precipitated synthetic amorphous silica
NM-200 was stored at ambient temperature in the dark under N2 atmosphere.
Specific details on test material used for the study:
- Name of test material (as cited in study report): FK700
- Analytical purity: SiO2-content: 86.65%


Ethical approval:
not specified
Details on study design:
Six human volunteers (5 males and 1 female; aged 22-28) received 2 x 1.25 g FK700 each dose in 250 mL apple juice each at day 4 (morning and midday) of an experimental period of 7 days. The urine was collected daily and analysed for the monomer SiO2 content (according to Baumann 1960).
Exposure assessment:
not specified

Results and discussion

The individual baseline values of the pre-test phase were very variable and individually different, mean excretion rates ranging from 16 to 71 mg/day. In the post-treatment phase, individual mean excretion rates ranged from 20 to 81 mg/day. After ingestion at day 4, the SiO2 excretion was increased in 5 of 6 subjects and ranged between 7 and 23 mg in urine compared to day 3. One of 6 subjects showed a decreased SiO2 excretion (26 mg). Overall, increases in excretion were not unequivocally detectable. The small apparent increases were in marked contrast to the high dose of 2500 mg SiO2 applied.

Applicant's summary and conclusion

No significant increased renal excretion of SiO2 after oral uptake resp. no significant oral absorption.