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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted standards, sufficiently documented, acceptable for assessment.
Reason / purpose:
reference to same study

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

Test material

Details on test material:
- Name of test material (as cited in study report): Aerosil
- Analytical purity: SiO2 content > 99.8 %
- Other: particle size: 10 to 40 nm; surface area: 175 m²


Details on study design:
Six human volunteers (5 males and 1 female; aged 22-28) received 2 x 1.25 g Aerosil each dose suspended 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 (day 1 -3) were very variable and individually different, mean excretion rates ranging from 25 to 87 mg/day. In the post-treatment phase (day 4 - 7), individual mean excretion rates ranged from 32 to 65 mg/day. After ingestion at day 4, in 3 of 6 subjects, the SiO2 content was increased in urine (20 -38 mg SiO2) compared to day 3. For the other 3 subjects, the SiO2 excretion was decreased or unchanged. 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