Silicic acid, aluminum magnesium sodium salt

Exposure related observations in humans: other data

Administrative data

Endpoint:

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

Reliability:

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

read-across source

Data source

Reference

Reference Type:

publication

Title:

Der Einfluss polymerer Kieselsaeuren auf die renale SiO2-Ausscheidung beim Menschen.

Author:

Langendorf, H. and Lang, K.

Year:

1967

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:

no

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Synthetic Amorphous Silica (SAS)

IUPAC Name:

Synthetic Amorphous Silica (SAS)

Test material form:

solid: particulate/powder

Remarks:

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%

Method

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

Results:

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

Conclusions:

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