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In Vitro Tests
Irritation: EpiDerm and
EpiOcular Assays
Standard irritation assays make use of human three dimensional tissue
equivalents (MatTek's EpiDerm and EpiOcular tissues). The models
allow for test materials to be applied topically, which facilitates
their use with solid and insoluble materials. The endpoint
for this assay is the determination of an EC50 time (the time that it
takes for tissue viability to be reduced to 50%), from which the
irritation potential of the material can be predicted. Additional
endpoints include assaying for chemical mediators of inflammation such
as IL-1alpha and PGE2.

EpiOcular Predicted In Vivo Irritancy
|
ET50
(minutes) |
In Vivo
Irritancy |
Draize Score |
|
> 240
|
Non-irritant |
0 |
|
15.7-240 |
Minimal |
0.1 - 15 |
|
7.9-15.6 |
Mild |
15.1 - 25 |
|
3.1-7.8 |
Moderate |
25.1 - 50 |
|
1.6-3.1 |
Severe |
50.1 – 80 |
|
<1.6 |
Extreme |
80.1 - 110 |
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