Diamond

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP conform study following guideline 90/385/EWG, 93/42/EWG and DIN EN ISO/IEC 17025 for testing of medical devices.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Type of study / information:

This in vitro method analyses the cytotoxic potential of the test item. The test is carried out using the mouse cell line L929 cultured with different
concentrations of an extract of the test item. The vitality of the cells or potential cytotoxic effects of the extract are registered via the protein content of the cell culture as compared to the controls.

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: ISO 10993-1 "Evaluation and testing within risk management process"

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: ISO 10993-5 "Tests for in vitro cytotoxicity"

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: ISO 10993-12 "Sample preparation and reference materials"

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Diamond

EC Number:

231-953-2

EC Name:

Diamond

Cas Number:

7782-40-3

Molecular formula:

C

IUPAC Name:

carbon

Details on test material:

Name: Synthetic Diamond Grade 2 (2 micron) Powder
CAS No.: 7782-40-3
Batch No.: 135-200-0125 -99 E634%CU33%WT33% REACH
Chemical Name: Diamond
Physical State: solid
Density: 3.52 g/cm3
Storage: at room temperature
Purity: >95 %
Expiry Date: no expiration date
Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety

Results and discussion

Any other information on results incl. tables

Test item: Synthetic diamond Grade 2 (2 micron) Powder

	Rel. Protein content (A550) (a)
	1	2	3	x	+	s	Growth inhibition in %
Blank	0.112	0.112	0.111	0.112	+	0.001
Positive control (b)	0.210	0.214	0.203	0.209	+	0.005	88
Negative control (c)	0.868	0.871	0.866	0.868	+	0.002	11
Solvent control
100 % v/v	0.963	0.975	0.934	0.957	+	0.017	0
66.7 % v/v	1.029	1.020	1.020	1.023	+	0.004	0
44.4 % v/v	1.051	1.012	1.051	1.038	+	0.018	0
29.6 % v/v	0.941	1.027	0.925	0.964	+	0.045	0
19.8 % v/v	0.986	0.995	1.042	1.008	+	0.025	0
13.2 % v/v	0.992	1.024	0.990	1.002	+	0.015	0
Test extract (d)
100 % v/v	0.839	0.846	0.799	0.828	+	0.021	15
66.7 % v/v	1.007	0.975	0.958	0.980	+	0.020	5
44.4 % v/v	1.017	1.017	1.009	1.014	+	0.004	3
29.6 % v/v	0.996	0.931	0.910	0.946	+	0.037	2
19.8 % v/v	1.007	1.008	1.030	1.015	+	0.011	0
13.2 % v/v	1.016	0.974	1.029	1.006	+	0.023	0

(a) 3 parallel cultures, mean + standard deviation

(b) 5% DMSO in DMEM l0% FCS

(c) PE material extracted in DMEM l0% FCS

(d) The test item was extracted under agitation in DMEM l0% FCS for 24 + 2 h at 37 + 1°C and the extract was cultured for 68 - 72 h with L929 cells at a final weight/volume ratio of 0.2 g test item / mL culture.

The controls confirmed the validity of the study. Cell growth of the positive cultures was inhibited by 88%. The extract of the negative control did not show a relevant inhibition of cell growth (11%).

Applicant's summary and conclusion

Conclusions:

In this study under the given conditions no leachable substances were released in cytotoxic concentrations from the test item.

Executive summary:

In the present study the cytotoxic effects of Synthetic Diamond Grade 2 (2 micron) Powder were analysed. Hereby, the test item was extracted under agitation for 24 + 2 h with cell culture medium and the extract was incubated with L929 cells for 68-72h. 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 leachable materials were released in cytotoxic concentrations from the test item.