0 cytotoxicity data – GC EUROPE Kalore User Manual
Page 29
![background image](/manuals/295858/29/background.png)
29
GC Kalore technical manual
Main differences between GC KALORE and GRADIA DIRECT shades
1. changes in terminology:
• Universal shades versus Standard shades.
• Opaque shades versus Inside special.
• Translucent shades versus Outside special.
2. changes in bleach shades:
• KALORE shades OBW and OXBW are same as GRADIA DIRECT BW and XBW shades.
• KALORE BW and XBW are new universal bleach shades with no equivalent GRADIA DIRECT
shade.
3. change in c2 and D2:
• KALORE C2 and D2 have a translucency similar to the other Universal shades. GRADIA DIRECT X
shade c2 and D2 are more translucent.
4. Change in NT and CT:
• KALORE CT and NT are slightly less translucent than CT and NT in GRADIA DIRECT.
8.0 Cytotoxicity data
KALORE was rigorously tested for toxicity of the new monomer (DX-511) using several tests based
on ISO7405 and 10993. All test results were negative for toxicity.
Table 9. Results of cytotoxicity tests with KALORE.
test item
method
Result
Cytotoxicity test
agar diffusion
negative
Sensitization test
Maximization
negative
irritation or intracutaneous reactivity
Oral mucosa irritation
negative
Subchronic systemic toxicity
negative
Genotoxicity
ames, mouse lymphoma
negative
local effects after implantation
1 month, 6 months
negative