Spinel (Mg(AlO2)2)

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-04-23 - 2009-11-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Type of study / information:

Determination of the resorption in the digestive tract of Spinel according to DIN 19738.

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: DIN 19738

Deviations:

yes

Remarks:

The composition of the test item was not determined, but calculated from information provided by the sponsor. Temperature in some conducts was outside the range of 37 ± 1 °C.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: DIN 19738

Deviations:

yes

Remarks:

The sediment was not leached with deionised H2O after centrifugation in order to avoid further dilution. The samples were stored in closed vessels at 2 - 8°C. The solutions were centrifuged at 2000 g, instead at 7000 g.

Test guideline 3

Qualifier:

according to guideline

Guideline:

other:

Deviations:

yes

Remarks:

The test item is a powder and was used without preparation (not ground).

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Spinel (Mg(AlO2)2)

EC Number:

215-105-9

EC Name:

Spinel (Mg(AlO2)2)

Cas Number:

1302-67-6

Molecular formula:

AlO2.1/2Mg

IUPAC Name:

magnesium dialuminium oxide

Applicant's summary and conclusion

Conclusions:

Findings and Results:

Two tests with and two tests without the addition of full milk powder have been performed, as well as two blanks with and without milk powder.
An aliquot of the remaining solutions then was thermically digested and resoluted in conc. HCl and water. The resulting solutions were measured via AAS for Mg and Al.
Al determinations were below LOQ, only Mg showed values a little above the blanks in samples which were digested with the addition of milk powder.
The mobilised masses of the measured elements and the bioaccessibilities are given in tabular form.
Samples without addition of milk powder:
Sample Mg 1 2 Mean sd RSD
mobilised masses of test item in µg/g 82.5 427 254 244 96%
bioaccessibility in % 4.9*10-4 2.5 *10-3 1.5 *10-3 1.4 *10-3 96%

Samples with addition of milk powder:
Sample Mg 3 4 Mean sd RSD
mobilised masses of test item in µg/g 605 689 647 59 9.2%
bioaccessibility in % 3.6 *10-3 4.1 *10-3 3.8 *10-3 3.5 *10-4 9.2%

Sample Al 1*
mobilised masses of test item in µg/g 25
bioaccessibility in % < 6.7 *10-5
* determined from the LOQ (0.25 mg/l)

Executive summary:

Findings and Results: Two tests with and two tests without the addition of full milk powder have been performed, as well as two blanks with and without milk powder. An aliquot of the remaining solutions then was thermically digested and resoluted in conc. HCl and water. The resulting solutions were measured via AAS for Mg and Al. Al determinations were below LOQ, only Mg showed values a little above the blanks in samples which were digested with the addition of milk powder. The mobilised masses of the measured elements and the bioaccessibilities are given in tabular form.

mobilised masses, bioaccessibility of Mg (Samples without addition of milk powder)

Sample Mg	1	2	Mean	sd	RSD
mobilised masses of test item in µg/g	82.5	427	254	244	96%
bioaccessibility in %	4.9*10^-4	2.5 *10^-3	1.5 *10^-3	1.4 *10^-3	96%

mobilised masses, bioaccessibility of Mg (Samples with addition of milk powder)

Sample Mg	3	4	Mean	sd	RSD
mobilised masses of test item in µg/g	605	689	647	59	9.2%
bioaccessibility in %	3.6 *10^-3	4.1 *10^-3	3.8 *10^-3	3.5 *10^-4	9.2%

mobilised masses, bioaccessibility of Al (calculated maximum)

Sample Al	Determined from LOQ	Calculated from Blank 1	Calculated from Blank 2
mobilised mass of test item in µg/g	< 25	< 12870	< 13458
bioaccessibility in %	< 6.7 *10^-5	< 0.034	< 0.036