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Additional toxicological data

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Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-12-07 - 2010-03-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Type of study / information:
Determination of the resorption in the digestive tract of White Fused Mullite according to DIN 19738 to determine the bioavailable parts.
Test guideline
Qualifier:
according to guideline
Guideline:
other: DIN 19738
Deviations:
yes
Remarks:
Temperature in some conducts was outside the range of 37 ± 1 °C. The samples were stored in closed vessels at 2 - 8°C. The solutions were centrifuged at 4779 g, instead of 7000 g.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Mullite
EC Number:
215-113-2
EC Name:
Mullite
Cas Number:
1302-93-8
Molecular formula:
Al6O13Si2
IUPAC Name:
Mullite

Results and discussion

Any other information on results incl. tables

Composition of Test Item

This was calculated from the data of X-ray analysis as presented in the following table:

Parameter

Mrin g/mol

% in Oxide

% in Test Item

µg/g Test Item

Al2O3

101.9613

100%

78.2%

-

Al

26.98

52.92%

41.39%

413862.936

Calculation of Mobilised Mass

The mobilised masses of the elements were calculated as

wi,mob = (ci * V)/mE

with

 

wi,mob                                     = mobilised part in µg/g test item per element

Ci                                           = measured element concentration in µg/L

V                                            = total volume in L of the aqueous phase (standard is 200 ml)

mE                                         = weight of used test item (standard is 2.0 g)

 Calculation of Bioaccessibility

Bioaccessibility was calculated as

 

Ri = (wi,mob * 100%)/wi,fest

with

 

Ri                                           = bioaccessible part in %

wi,mob                                     = mobilised part in µg/g test item per element

wi,fest                                      = part of the element in the test item in µg/g

Results

The concentrations of Al in the tests are higher than in the blanks, calculation of a limit bio-accessibility for Al was based on the LOQ and compared to the values which were found in the blanks because calculation of effective concentrations was not reasonable.

Samples without addition of milk powder:

Parameter

Mean

Standard Deviation

Relative Standard Deviation (%)

Mobilised mass of test item in µg/g

34.50

4.61

13.4%

Bioavailability in %

0.0083%

0.0001

13.36%

Samples with addition of milk powder:

Parameter

Mean

Standard Deviation

Relative Standard Deviation (%)

Mobilised mass of test item in µg/g

1276.60

147.84

11.6%

Bioavailability in %

0.3085%

0.0004

11.58%

Applicant's summary and conclusion

Conclusions:
All values in the samples were marginally above the values of the blanks. The values in the samples with addition of milk powder were higher than the values in the samples without milk powder. Bio-accessibility in the samples with addition of milk powder was 0.3085 % with RSD of 11.58 %.
Bio-accessibility was doubtlessly low, though, as no values lying significantly above the blanks were found.
Executive summary:

All values in the samples were marginally above the values of the blanks. The values in the samples with addition of milk powder were higher than the values in the samples without milk powder. Bio-accessibility in the samples with addition of milk powder was 0.3085 % with RSD of 11.58 %.

Bio-accessibility was doubtlessly low, though, as no values lying significantly above the blanks were found.