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Diss Factsheets

Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-08-17 - 2009-12-08
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 lung of pleonastic spinel in order to determine the bio-accessible parts
Test guideline
Qualifier:
according to guideline
Guideline:
other: „Bioaccessibility testing of Cobalt compounds", Woodhall Stopford at al., J. Environ. Monit. 5, 2003, 675 - 680
Deviations:
yes
Remarks:
Shaking was performed for two hours only in order to prevent too high temperatures in the incubator. As no dissolution was observed in the first flasks, this is considered as uncritical concerning the outcome of the study.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ceramic materials and wares, chemicals
EC Number:
266-340-9
EC Name:
Ceramic materials and wares, chemicals
Cas Number:
66402-68-4
Molecular formula:
spinel of the pleonaste type containing (Mg,Fe)(Al,Fe)2O4
IUPAC Name:
not applicable

Results and discussion

Any other information on results incl. tables

Calculation of Mobilised Mass

The mobilised masses of the two elements were calculated from

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 (0.05 L in all samples)

mE             = weight of used test item (nominal: 1.0 g, real weights were used for calc.)

 

Bioaccessibility was calculated as

Ri  = (wi,mob   * 100%)/wi,total   

with

Ri               = bioaccessible part in %

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

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

 

As the concentrations of Al in the blanks and in the tests lower than LOQ (Al), calculation of a limit bio-accessibility for Al was based on the LOQ.

Bioaccessible Part Al, summary (determined from LOQ Al, 0.25 mg/l)

Parameter

Mean

Mobilised mass of test item in µg/g

<11.9

Bioaccessibility in %

<6.13*10-5

As the concentrations of Fe in the blanks and in the first samples (1-6) were lower than LOQ (Fe), calculation of a limit bio-accessibility for Fe was based on the samples 7 and 8 (taken after 72h).


 Bioaccessible Part Fe, summary

Parameter

Mean(72h)

Standard Deviation

Relative Standard Deviation(%)

Mobilised mass of test item in  

µg/g

2.17

0.14

6.6%

Limit Bioaccessibility in %

1.19* 10-5

7.80 *10-7

6.6%

BioaccessiblePart Mg,summary

Parameter

Mean(72h)

Standard Deviation

Relative Standard Deviation(%)

Mobilised mass of test item in  

µg/g

6865

77.99

1%

Bioaccessibility in %

3.25* 10 -2

3.70 *10 -4

1%
    

Applicant's summary and conclusion

Conclusions:
The test item was incubated in synthetical lung fluid (Modified Gambles solution) for a period of three days. Incubation temperature was 37 °C, atmosphere contained 5% CO2.
Samples were taken after 2, 5, 24 and 72 hours incubation time. At each sampling, two flasks were opened and filtrated through 0.45-µm membrane filters. Concentration of the test item was measured using flame AAS after addition of 1% (V/V) conc. HCI. The blanks were analysed at the last sampling point only.
All Al concentrations lay below LOQ.
In two samples (7, 8), Fe values were higher than LOQ. These were used for the determination of a bio-accessibility limit.
Because of the presence of Mg in blanks of the synthetical lung fluid, the bioaccessibility was determined from Al- and Fe-content only.
Bioaccessibility from Al content: < 6.13 E-5 %
Bioaccessibilty from Fe content: 1.19 E-5 %
Executive summary:

The test item was incubated in synthetical lung fluid (Modified Gambles solution) for a period of three days. Incubation temperature was 37 °C, atmosphere contained 5% CO2. Samples were taken after 2, 5, 24 and 72 hours incubation time. At each sampling, two flasks were opened and filtrated through 0.45-µm membrane filters. Concentration of the test item was measured using flame AAS after addition of 1% (V/V) conc. HCI. The blanks were analysed at the last sampling point only. All Al concentrations lay below LOQ. In two samples (7, 8), Fe values were higher than LOQ. These were used for the determination of a bio-accessibility limit. Because of the presence of Mg in blanks of the synthetical lung fluid, the bioaccessibility was determined from Al- and Fe-content only.

Parameter Al

Mean*

Mobilised mass of test item

<11.9 µg/g

Bioaccessibility

< 6.13 * 10 -5%

*determinated from LOQ Al,0.25mg/L

Parameter Fe

Mean(72h)

Standard Deviation

Relative Standard Deviation(%)

Mobilised mass of test item

2.17 µg/g

0.14  µg/g

6.6%

Bioaccessibility %

1.19 *10-5%

7.80 * 10 -7 %

6.6%