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Administrative data

Type of information:
experimental study
Adequacy of study:
supporting study
1 (reliable without restriction)

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
other: Guideline ISO 10993, published by the International Organization for Standardization: "Biological Evaluation of Medical Devices" Part 5: "Tests for cytotoxicity: In vitro methods", 1992.
Principles of method if other than guideline:
Test procedure:
See comments.
GLP compliance:
yes (incl. QA statement)
Type of method:
in vitro

Test material

Constituent 1
Reference substance name:

Results and discussion

Details on results:
Slight toxic effects were observed following incubation with
the concentration of 625 micrograms per millilitre of the
test item. From the concentration of 1250 micrograms per mL
up to the highest tested concentration (5000 micrograms per
mL) clear cytotoxic effects occured. The calculated XTT50
value is 1104,7 micrograms per mL.

Any other information on results incl. tables

This in vitro study was performed to assess the cytotoxic potential of 1-H-Tetrazol- 5amine- ,N-1H-tetrazol-5-yl-,monoammonium salt by means of the XTT test using the mouse cell line L929.

The following concentrations of the test item were tested: 39.1, 78.1, 156.3, 312.5, 625, 1250, 2500, 5000 microg/mL

Complete medium (RPMI 1640 containing 10% (v/v) FCS) was used as negative control and solvent control for the test item.

The solvent control for the positive control was also RPMI 1640 medium containing 10% (v/v) FCS and 10.0% (v/v) deion. water.

SDS was used as positive control. The following concentrations were applied: 3.125, 6.25, 12.5, 25, 50, 100, 125, 250 microg/mL The incubation time was 24 hours at 37 ± 1.5 °C.

The negative control and the solvent control showed no reduction in cell viability.

The positive control (SDS) induced a distinct dose-related reduction in cell viability.

Slight toxic effects were observed following incubation with the concentration of 625 jg/mL of 1-H-Tetrazol-5amine-,N-1H-tetrazol-5-yl-,monoammonium salt. From the concentration of 1250 microg/mL up to the highest tested concentration (5000 microg/mL) clear cytotoxic effects occurred. The calculated XTT50 value is 1104.7 microg/mL.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item 1-H-Tetrazol-5amine-,N-1H-tetrazol-5-yl-,monoammonium salt possesses a cytotoxic potential.

Applicant's summary and conclusion