Silicon carbide

Specific investigations: other studies

Administrative data

Endpoint:

cytotoxicity

Type of information:

experimental study

Adequacy of study:

other information

Study period:

28 November 2007 - 04 February 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study generated according to internationally accepted testing guidelines.

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: ISO 10993-1

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: ISO 10993-5

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: ISO 10993-12

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

in vitro

Test animals

Details on test animals or test system and environmental conditions:

The test was carried out with L929 cells (ATCC No. CCL1, NCTC clone 929 (connective tissue mouse), clone of strain L (DSMZ)).
For the test cells were cultured in 75 cm² culture flasks (Greiner) in DMEM (Biochrom) with 10% FCS-Gold (PAA) at 37 +/- 1° C and 5.0% CO2.

Administration / exposure

Details on exposure:

1. Solvent control: DMEM 10% FCS
2. Negative control: Polyethylene extracted in DMEM 10% FCS
3. Positive control: DMSO (5%) in DMEM 10% FCS
4. Test Item: 6 concentrations of the test extract (13.2%, 19.8%, 29.6%, 44.4%, 66.7% and 100%)

Details on study design:

Controls were set up in parallel to the test item cultures in order to confirm the validity of the test. The negative control, Polyethylene material (Art. No. 188.271, Lot 04080197, Greiner), was extracted at a weight/volume ratio of 1 g/5 mL medium for 24 h at 37 +/- 1°C. The positive control, Dimethylsulfoxide (DMSO 99.5%, Lot 6H007912, Applichem), was set up in a final concentration of 5% in DMEM 10% FCS. A solvent control, consisting of extraction vehicle (DMEM 10% FCS) alone and treated in the same way as the treatment groups was included.

Examinations

Examinations:

Cytotoxic effects were assumed to be based on the protein content of the cultures, which is used as a measure for cell growth. Clear cytotoxicity was defined as an effect leading to an inhibition of cell growth of more than 30% as compared to the cultures treated with solvent controls.

Applicant's summary and conclusion

Conclusions:

Under the given conditions no substances with clear cytotoxic potential (leading to a cell growth inhibition of more than 30%) were released from the test item.

Executive summary:

In the present study the cytotoxic effects of SiC, TRS-9899-100F were analysed. Hereby, the test item was extracted under agitation for 24 h with cell culture medium and the extract was incubated with L929 cells for 68 h. The protein content of the individual cultures was then analysed as a measure for cytotoxicity and compared to those of the controls. In this study under the given conditions no substances with clear cytotoxic potential (leading to a cell growth inhibition of more than 30%) were released from the test item.