Silicon carbide

Additional physico-chemical information

Administrative data

Endpoint:

other: analysis of extractable organic substances and soluble inorganic elements

Type of information:

experimental study

Adequacy of study:

other information

Study period:

21 January - 05 February 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study generated according to internationally accepted guidelines.

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: ISO 10993-12

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: ISO 10993-18

Deviations:

no

GLP compliance:

yes

Remarks:

except ICP investigation

Results and discussion

Any other information on results incl. tables

Investigation of Extractable Organic Substances (GC/MS Fingerprint)

Water Extracts: No product-related peaks were detected in the GC/MS fingerprint chromatograms of the water extracts of the investigated three different silicon carbide powders as compared to the chromatograms of the negative control (pure extraction medium).

Isopropy Alcohol Extracts: No product-related peaks were detected in the GC/MS fingerprint chromatograms of the isopropyl alcohol extracts of the investigated three different silicon carbide powders as compared to the chromatograms of the negative control (pure extraction medium).

n-Hexane Extracts: No product-related peaks were detected in the GC/MS fingerprint chromatograms of the n-hexane extracts of the investigated three different silicon carbide powders as compared to the chromatograms of the negative control (pure extraction medium).

ICP-lnvestigation

The ICP screening of the water extract of the silicon carbide powder 'TRS-9899-100F' showed the presence of the following elements.

Water extract of negative control: B, Ba, Ca, K, Mg, Na, Si.

Water extract of silicon carbide powder: B, Ba, Ca, K, Mg, Na, Si, Al, S, V, Sr.

After the screening the aqueous solutions (extract and negative control) were subjected to the quantification of the identified metallic ions. As the elements boron (B), and sodium (Na) were present in the negative control as well as in the test item extract to a similar content and were most likely extracted from the used glass-vials, a quantification was not performed. The individual results are given in the following table:

Sample | amount in µg/ml	Al	Ba	Ca	K	Mg	S	Si	Sr	V
negative control	<0.01	<0.01	0.02	<0.1	<0.01	0.1	0.3	<0.01	<0.01
SiC, TRS-9899-100F	0.07	0.01	3.2	1.1	0.12	2.2	5.5	0.02	1.1

In the table below the determined amounts of inorganic elements were related to the 1 g of powder:

Sample | amount in µg/g powder	Al	Ba	Ca	K	Mg	S	Si	Sr	V
negative control	<0.05	<0.05	0.10	<0.5	<0.05	0.5	1.5	<0.05	<0.05
SiC, TRS-9899-100F	0.35	0.05	16.0	5.5	0.6	11.0	27.5	0.10	5.5

Applicant's summary and conclusion

Conclusions:

It can be concluded, that the GC/MS fingerprint investigation showed that no product related volatile or semivolatile organic substance could be detected in the several liquid extracts of the three different silicon carbide powders.
In the ICP investigation and in comparison to pure w ater, amounts of silicon, calcium, sulfur, potassium and vanadium w ere detected in the water extract of the silicon carbide powder 'TRS-9899-100F'. Furthermore, traces of barium, strontium, aluminum and magnesium could be detected.