Mullite

Additional toxicological data

Administrative data

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

Test material information

Constituent 1

Reference substance name:

Mullite

EC Number:

215-113-2

EC Name:

Mullite

Cas Number:

1302-93-8

Molecular formula:

Al6O13Si2

IUPAC Name:

Mullite; Al6O13Si2

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

 

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

C_i                                           = measured element concentration in µg/L

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

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

 Calculation of Bioaccessibility

Bioaccessibility was calculated as

 

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

with

 

R_i                                           = bioaccessible part in %

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

w_i,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.