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Toxicological information

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:
1966
Report date:
1966
Reference Type:
publication
Title:
No information
Author:
Langendorf H, Lang K
Year:
1967
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

Constituent 1
Chemical structure
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

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]
(test phase)

32.3

64.5

61.3

60.8

44.5

52.9

           FK 700     

Test person

4

5

6

7

8

9

Sum SiO2
day 1 – 3 [mg/d] (control)

42.4

36.8

71.4

16.1

39.9

27.4

Sum SiO2
day 4 – 7 [mg/d]
(test phase)

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.  

   --------------------------

Applicant's summary and conclusion