Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Guideline ISO 10993, Part 5 and EN 7405
Deviations:
not applicable
Principles of method if other than guideline:
Test procedure:
See comments.
GLP compliance:
yes (incl. certificate)
Type of method:
in vitro

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Details on results:
Cytotoxic effects were observed following incubation
with the highest tested concentration of the test item

(5000 micro grams per mL). At lower concentrations cytotoxic
effects did not occur. The calculated XTT 50 value is 3614,2
micro g per millilitre.

Any other information on results incl. tables

With the XTT test, cell proliferation and viability as well
as mitochondrial metabolic competence of the cells after
treatment with the test item is determined colourimetri-
cally. The XXT test is based on the cleavage of the yellow
Tetrazoliumsalt XTT to form orange water soluble formazan
dye by dehydrogenase activity in active mitochondria. This
method was first described 1988 by SCUDIERO et al. and
improved in subsequent years by several other investigators.

Applicant's summary and conclusion