Ceramic materials and wares, chemicals

Additional toxicological data

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

Test material information

Constituent 1

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

w_i,mob  = (C_i   * V)/m_E 

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 (0.05 L in all samples)

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

 

Bioaccessibility was calculated as

R_i  = (w_i,mob   * 100%)/w_i,total   

with

R_i               = bioaccessible part in %

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

w_i,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%